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Kempf K, Martin S. Effects of a Carbohydrate Meal on Lipolysis. Nutrients 2024; 16:3531. [PMID: 39458525 PMCID: PMC11510632 DOI: 10.3390/nu16203531] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2024] [Revised: 10/08/2024] [Accepted: 10/10/2024] [Indexed: 10/28/2024] Open
Abstract
BACKGROUND Due to the increasing prevalence of obesity and type 2 diabetes, effective dietary recommendations are needed. Previously, we developed the low-insulin method: by avoiding insulinogenic, i.e., insulin-release-triggering foods, insulin secretion becomes reduced, lipolysis is stimulated, and energy production is shifted to ketosis with excess ketone bodies exhaled in the form of acetone. Now, we investigate how quickly stable ketosis (defined as fasting breath acetone concentration ≥ 7.0 ppm) is achieved, whether and for how long a carbohydrate meal inhibits ketosis, and whether the responses differ in healthy adults with different insulin levels. METHODS An oral glucose tolerance test was conducted, and body composition and fasting insulin were determined at the beginning and end of the 14-day study. Participants (n = 10) followed a ketogenic diet and performed continuous glucose monitoring. Ketosis levels were determined by measuring breath acetone concentrations. On day 8, two white bread rolls with jam (72 g carbohydrates) were consumed for breakfast. RESULTS After seven days, all participants achieved stable ketosis (defined as fasting breath acetone concentration ≥ 7.0 ppm), which dropped from 8.2 to 5.7 ppm (p = 0.0014) after the carbohydrate meal. It took five days to achieve stable ketosis again. The stratification of participants into tertiles according to their fasting insulin levels demonstrated that individuals with low fasting insulin levels achieved stable ketosis again after two days and those with medium insulin levels after five days, while those with high baseline values did not reach stable ketosis by the end of the study. CONCLUSIONS By carbohydrate restriction, stable ketosis can be achieved within one week. However, a single carbohydrate meal inhibits ketosis for several days. This effect is pronounced in individuals with elevated fasting insulin levels.
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Affiliation(s)
- Kerstin Kempf
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany;
| | - Stephan Martin
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany;
- Medical Faculty and University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, 40225 Dusseldorf, Germany
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Peyyety V, Zupa MF, Hewitt B, Rodriguez Gonzalez A, Mani I, Prioleau T, McCurley J, Lin YK, Vajravelu ME. Barriers and Facilitators to Uptake of Continuous Glucose Monitoring for Management of Type 2 Diabetes Mellitus in Youth. Sci Diabetes Self Manag Care 2023; 49:426-437. [PMID: 37927056 PMCID: PMC10895543 DOI: 10.1177/26350106231205030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/07/2023]
Abstract
PURPOSE The purpose of this study was to identify factors impacting the acceptability of continuous glucose monitoring (CGM) in adolescents and young adults (AYAs) with type 2 diabetes mellitus (T2DM). METHODS In this single-center study, semistructured interviews were conducted with AYAs with T2DM and their parents to determine attitudes about CGM, including barriers and facilitators. Interviews were audio-recorded, transcribed, and evaluated using thematic analysis. RESULTS Twenty AYAs and 10 parents participated (n = 30 total). AYAs were mean age 16.5 years (SD 2.2, range = 13.7-20.1) and had median diabetes duration of 1.3 years. Most were female (65%) and from minoritized background (40% non-Hispanic Black, 10% Hispanic, 5% Asian). Seven (35%) used CGM. The primary facilitator elicited was convenience over glucose meter use. Important barriers included the impact of physically wearing the device and drawing unwanted attention, desire for AYA privacy, and inadequate education about the device. CONCLUSIONS In this diverse sample of AYAs with T2DM and their parents, CGM was generally regarded as convenient, although concerns about worsening stigma and conflict with parents were prevalent. These findings can guide the development of patient-centered approaches to CGM for AYAs with T2DM, a critical step toward reducing inequities in diabetes technology uptake.
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Affiliation(s)
- Vaishnavi Peyyety
- Division of Pediatric Endocrinology, Diabetes, and Metabolism and Center for Pediatric Research in Obesity and Metabolism, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
| | - Margaret F Zupa
- Division of Endocrinology and Metabolism, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Brianna Hewitt
- Division of Pediatric Endocrinology, Diabetes, and Metabolism and Center for Pediatric Research in Obesity and Metabolism, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
| | | | - Iswariya Mani
- Division of Pediatric Endocrinology, Diabetes, and Metabolism and Center for Pediatric Research in Obesity and Metabolism, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
| | | | - Jessica McCurley
- Department of Psychology, San Diego State University, San Diego, California
| | - Yu Kuei Lin
- Division of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, Michigan
| | - Mary Ellen Vajravelu
- Division of Pediatric Endocrinology, Diabetes, and Metabolism and Center for Pediatric Research in Obesity and Metabolism, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
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Han CY, Zhang J, Ye XM, Lu JP, Jin HY, Xu WW, Wang P, Zhang M. Telemedicine-assisted structured self-monitoring of blood glucose in management of T2DM results of a randomized clinical trial. BMC Med Inform Decis Mak 2023; 23:182. [PMID: 37710226 PMCID: PMC10500819 DOI: 10.1186/s12911-023-02283-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2022] [Accepted: 09/02/2023] [Indexed: 09/16/2023] Open
Abstract
BACKGROUND This prospective study aimed to compare telemedicine-assisted structured self-monitoring of blood glucose(SMBG) with a traditional blood glucose meter (BGM) in adults of type 2 diabetes mellitus (T2DM). METHODS Adult participants with T2DM were assigned to an intervention group or a control group. The patients in the intervention group received a connected BGM with real-time data submission as well as individual needs-based tele-coaching to address and improve motivation and daily diabetes self-management. The patients in the control group received a traditional BGM. Changes in glycated hemoglobin(HbA1c), low blood glucose index(LBGI), and diabetes self-management behaviors were analyzed. RESULTS The study demonstrated the superiority of the telemedicine-assisted structured SMBG versus the traditional BGM for improving HbA1c. Additionally, the telemedicine-assisted SMBG reduced the risk of hypoglycemia and enhanced diabetes self-management behaviors, as differences in the LBGI and the Diabetes Self-Management Questionnaire(DSMQ) results between the groups after 6 months were found to be significant. CONCLUSIONS Telemedicine-assisted structured SMBG helps physicians and patients to achieve a specific level of glycemic control and reduce hypoglycemia. The use of coaching applications and telemedicine-assisted SMBG indicated beneficial effects for T2DM self-management, which may help limit disease progression. TRIAL REGISTRATION Chinese Clinical Trail Registry No: ChiCTR2300072356 on 12/06/2023. Retrospectively registered.
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Affiliation(s)
- Chen-Yu Han
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China
| | - Jian Zhang
- Department of Pharmacology, Medical College of Shaoxing University, Shaoxing, 312000, China
| | - Xiao-Mei Ye
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China
| | - Jia-Ping Lu
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China
| | - Hai-Ying Jin
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China
| | - Wei-Wei Xu
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China
| | - Ping Wang
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China
| | - Min Zhang
- Department of Endocrinology, Qingpu Branch of Zhongshan Hospital affiliated to Fudan University, No.1158 of Gongyuan Road, Qingpu District, Shanghai, 201700, China.
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Zou Y, Zhao S, Li G, Zhang C. The Efficacy and Frequency of Self-monitoring of Blood Glucose in Non-insulin-Treated T2D Patients: a Systematic Review and Meta-analysis. J Gen Intern Med 2023; 38:755-764. [PMID: 36403159 PMCID: PMC9971532 DOI: 10.1007/s11606-022-07864-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2022] [Accepted: 10/21/2022] [Indexed: 11/21/2022]
Abstract
BACKGROUND Self-monitoring of blood glucose (SMBG) is a useful tool in diabetes management, but its efficacy and optimal application in type 2 diabetes (T2D) patients treated without insulin have been controversial. We aimed to evaluate the efficacy of SMBG in controlling blood glucose levels in non-insulin-treated T2D patients and to determine the optimal frequency and the most appropriate population to benefit from SMBG. METHODS Eligible publications from January 2000 to April 2022 were retrieved from PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases. Randomized controlled trials comparing SMBG with no SMBG or structured SMBG (S-SMBG, SMBG with defined timing and frequency of glucose measurements) were included. Meta-analyses and sub-analyses were performed to assess the efficacy, optimal frequency, and most appropriate population for SMBG. Risk of bias was assessed regarding randomization, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases. RESULTS Twenty-two studies involving 6204 participants were identified, including 17 comparing SMBG with no SMBG and 4 comparing SMBG with S-SMBG. SMBG reduced HbA1c (MD -0.30%, 95% CI -0.42 to -0.17) compared with no SMBG, and S-SMBG performed better than SMBG (MD -0.23%, 95% CI -0.38 to -0.07). Subgroup analyses showed that HbA1c control was better with SMBG at 8-11 times weekly (MD -0.35%, 95% CI -0.51 to -0.20) compared with other frequencies and with lifestyle adjustments (MD -0.37%, 95% CI -0.50 to -0.23) than with no adjustments. No significant differences in HbA1c were observed between baseline HbA1c subgroups (≤ 8% and > 8%, P = 0.63) and between diabetes duration subgroups (≤ 6 years and > 6 years, P = 0.72), respectively. DISCUSSION SMBG was effective for controlling HbA1c in non-insulin-treated T2D patients, although lacking detailed monitoring design. Better outcomes were seen with SMBG at 8-11 times weekly and lifestyle adjustment based on SMBG results. TRIAL REGISTRATION PROSPERO (CRD42021285604).
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Affiliation(s)
- Yue Zou
- Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China
| | - Sixuan Zhao
- Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China
| | - Guangyao Li
- Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China
| | - Chao Zhang
- Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
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Holmes-Truscott E, Baptista S, Ling M, Collins E, Ekinci EII, Furler J, Hagger V, Manski-Nankervis JA, Wells C, Speight J. The impact of structured self-monitoring of blood glucose on clinical, behavioral, and psychosocial outcomes among adults with non-insulin-treated type 2 diabetes: a systematic review and meta-analysis. FRONTIERS IN CLINICAL DIABETES AND HEALTHCARE 2023; 4:1177030. [PMID: 37153750 PMCID: PMC10157033 DOI: 10.3389/fcdhc.2023.1177030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 03/01/2023] [Accepted: 04/04/2023] [Indexed: 05/10/2023]
Abstract
Background Self-monitoring of blood glucose (SMBG) is considered of little clinical benefit for adults with non-insulin-treated type 2 diabetes, but no comprehensive review of a structured approach to SMBG has been published to date. Purpose To conduct a systematic review and meta-analysis of the impact of sSMBG on HbA1c, treatment modifications, behavioral and psychosocial outcomes, and; examine the moderating effects of sSMBG protocol characteristics on HbA1c. Data sources Four databases searched (November 2020; updated: February 2022). Study selection Inclusion criteria: non-randomized and randomized controlled trials (RCTs) and prospective observational studies; reporting effect of sSMBG on stated outcomes; among adults (≥18 years) with non-insulin-treated type 2 diabetes. Studies excluded if involving children or people with insulin-treated or other forms of diabetes. Data extraction and analysis Outcome data extracted, and risk of bias/quality assessed independently by two researchers. Meta-analysis was conducted for RCTs, and moderators explored (HbA1c only). Data synthesis From 2,078 abstracts, k=23 studies were included (N=5,372). Risk of bias was evident and study quality was low. Outcomes assessed included: HbA1c (k=23), treatment modification (k=16), psychosocial/behavioral outcomes (k=12). Meta-analysis revealed a significant mean difference favoring sSMBG in HbA1c (-0·29%, 95% CI: -0·46 to -0·11, k=13) and diabetes self-efficacy (0.17%, 95% CI: 0.01 to 0.33, k=2). Meta-analysis revealed no significant moderating effects by protocol characteristics. Limitations Findings limited by heterogeneity in study designs, intervention characteristics, and psychosocial assessments. Conclusion A small positive effect of sSMBG on HbA1c and diabetes self-efficacy was observed. Narrative synthesis of sSMBG intervention characteristics may guide future implementation. PROSPERO registration https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020208857, identifier CRD42020208857.
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Affiliation(s)
- Elizabeth Holmes-Truscott
- School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia
- *Correspondence: Elizabeth Holmes-Truscott,
| | - Shaira Baptista
- School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia
| | - Mathew Ling
- School of Psychology, Deakin University, Geelong, VIC, Australia
- Neami National, Preston, VIC, Australia
| | | | - EIif I. Ekinci
- Department of Medicine, Austin Health, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia
- The Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Melbourne, VIC, Australia
| | - John Furler
- Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia
| | - Virginia Hagger
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia
- School of Nursing and Midwifery, Faculty of Health, Deakin University, Burwood, VIC, Australia
| | - Jo-Anne Manski-Nankervis
- The Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Melbourne, VIC, Australia
- Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia
| | | | - Jane Speight
- School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia
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Lee CS, Westland H, Faulkner KM, Iovino P, Thompson JH, Sexton J, Farry E, Jaarsma T, Riegel B. The effectiveness of self-care interventions in chronic illness: a meta-analysis of randomized controlled trials. Int J Nurs Stud 2022; 134:104322. [DOI: 10.1016/j.ijnurstu.2022.104322] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2022] [Revised: 06/21/2022] [Accepted: 06/28/2022] [Indexed: 11/30/2022]
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Schembre SM, Jospe MR, Bedrick EJ, Li L, Brewster AM, Levy E, Dirba DD, Campbell M, Taylor RW, Basen-Engquist KM. Hunger Training as a self-regulation strategy in a comprehensive weight loss program for breast cancer prevention: a randomized feasibility study. Cancer Prev Res (Phila) 2021; 15:193-201. [PMID: 34893531 DOI: 10.1158/1940-6207.capr-21-0298] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2021] [Revised: 09/30/2021] [Accepted: 12/06/2021] [Indexed: 11/16/2022]
Abstract
Weight losses >10% favorably modulate biomarkers of breast cancer risk but are not typically achieved by comprehensive weight loss programs, including the Diabetes Prevention Program (DPP). Combining the DPP with Hunger Training (HT), an evidence-based self-regulation strategy that uses self-monitored glucose levels to guide meal timing, has potential to enhance weight losses and cancer-related biomarkers, if proven feasible. This 2-arm RCT examined the feasibility of adding HT to the DPP and explored effects on weight and metabolic and breast cancer risk biomarkers. Fifty postmenopausal women (BMI > 27 kg/m2) at risk of breast cancer were randomized to the DPP+HT or DPP-only arm. Both arms followed a 16-week version of the DPP delivered weekly by a trained registered dietitian. Those in the DPP+HT also wore a continuous glucose monitor during weeks 4-6 of the program. Feasibility criteria were accrual rates > 50%, retention rates > 80%, and adherence to the HT protocol >75%. All a priori feasibility criteria were achieved. The accrual rate was 67%; retention rate was 81%; and adherence to HT was 90%. Weight losses and BMI reductions were significant over time as were changes in metabolic and breast cancer risk biomarkers but did not vary by group. This trial demonstrated that HT was feasible to add to comprehensive weight management program targeted towards postmenopausal women at high risk of breast cancer, though upon preliminary examination it does not appear to enhance weight loss or metabolic changes.
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Affiliation(s)
- Susan M Schembre
- Department of Family and Community Medicine, University of Arizona
| | | | - Edward J Bedrick
- Center for Biomedical Informatics and Biostatistics, University of Arizona
| | - Liang Li
- The University of Texas MD Anderson Cancer Center
| | - Abenaa M Brewster
- Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center
| | - Erma Levy
- Behavioral Science, The University of Texas MD Anderson Cancer Center
| | | | - Morgan Campbell
- Behavioral Science, The University of Texas MD Anderson Cancer Center
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Cheng AYY, Feig DS, Ho J, Siemens R. Blood Glucose Monitoring in Adults and Children with Diabetes: Update 2021. Can J Diabetes 2021; 45:580-587. [PMID: 34511234 DOI: 10.1016/j.jcjd.2021.07.003] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2021] [Indexed: 12/14/2022]
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Weinstock RS, Braffett BH, McGuigan P, Larkin ME, Grover NB, Walders-Abramson N, Laffel LM, Chan CL, Chang N, Schwartzman BE, Barajas RA, Celona-Jacobs N, Haymond MW. Self-Monitoring of Blood Glucose in Youth-Onset Type 2 Diabetes: Results From the TODAY Study. Diabetes Care 2019; 42:903-909. [PMID: 30833375 PMCID: PMC6489117 DOI: 10.2337/dc18-1854] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/04/2018] [Accepted: 02/04/2019] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To determine whether self-monitoring of blood glucose (SMBG) is associated with lower HbA1c in youth with type 2 diabetes taking oral medications only or after starting insulin for persistently elevated HbA1c. RESEARCH DESIGN AND METHODS Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study participants (n = 699) taking oral medications were asked to perform SMBG twice daily. After reaching primary outcome (PO) (HbA1c ≥8% [64 mmol/mol]) over 6 months or an inability to wean from temporary insulin because of metabolic decompensation), insulin glargine was started. HbA1c and percent of SMBG (SMBG%) (percent days when the meter was used one or more times) before and after PO were analyzed. RESULTS SMBG declined over time and was inversely related to HbA1c (P < 0.0001). Of 298 youth who reached PO and started insulin, 282 had SMBG data. At PO, mean ± SD age was 15.8 ± 2.3 years, BMI 35.5 ± 7.9 kg/m2, and HbA1c 9.6 ± 2.0% (81 ± 21.9 mmol/mol); 65.3% were female. Median SMBG% was 40% at PO, which increased to 49% after 6 months and fell to 41% after 1 year on insulin. At PO, 22% of youth checked ≥80% of days, which increased to 25% and fell to 19% after 6 and 12 months using insulin, respectively. At PO, compared with those who checked <80%, youth who checked ≥80% were younger and with a lower BMI, HbA1c, and blood pressure. SMBG ≥80% was associated with ≥1% reduction in HbA1c at 6 and 12 months after insulin initiation. CONCLUSIONS Low SMBG adherence was common and associated with higher HbA1c. Optimal SMBG frequency in youth using or not using insulin, and whether less frequent SMBG is a marker for overall worse self-care, require further study.
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Affiliation(s)
- Ruth S Weinstock
- State University of New York Upstate Medical University, Syracuse, NY
| | | | - Paul McGuigan
- Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, OH
| | - Mary E Larkin
- Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, MA
| | - Nisha B Grover
- The Biostatistics Center, George Washington University, Rockville, MD
| | | | - Lori M Laffel
- Joslin Diabetes Center, Harvard Medical School, Boston, MA
| | | | - Nancy Chang
- Children's Hospital of Los Angeles, Los Angeles, CA
| | | | - Rose Ann Barajas
- University of Texas Health Science Center San Antonio, San Antonio, TX
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Pfützner A, Strobl S, Demircik F, Redert L, Pfützner J, Pfützner AH, Lier A. Evaluation of a New Noninvasive Glucose Monitoring Device by Means of Standardized Meal Experiments. J Diabetes Sci Technol 2018; 12:1178-1183. [PMID: 29451016 PMCID: PMC6232728 DOI: 10.1177/1932296818758769] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
BACKGROUND Frequent blood glucose readings are the most cumbersome aspect of diabetes treatment for many patients. The noninvasive TensorTip Combo Glucometer (CoG) component employs dedicated mathematical algorithms to analyze the collected signal and to predict tissue glucose at the fingertip. This study presents the performance of the CoG (the invasive and the noninvasive components) during a standardized meal experiment. METHODS Each of the 36 participants (18 females and males each, age: 49 ± 18 years, 14 healthy subjects, 6 type 1 and 16 type 2 patients) received a device for conducting calibration at home. Thereafter, they ingested a standardized meal. Blood glucose was assessed from capillary blood samples by means of the (non)invasive device, YSI Stat 2300 plus, Contour Next at time points -30, 0, 15, 30, 45, 60, 75, 90, 120, 150, and 180 minutes. Statistical analysis was performed by consensus error grid (CEG) and calculation of mean absolute relative difference (MARD) in comparison to YSI. RESULTS For the noninvasive (NI) CoG technology, 100% of the data pairs were found in CEG zones A (96.6%) and B (3.4%); 100% were seen in zone A for the invasive component and Contour Next. MARD was calculated to be 4.2% for Contour Next, 9.2% for the invasive component, and 14.4% for the NI component. CONCLUSIONS After appropriate individual calibration of the NI technology, both the NI and the invasive CoG components reliably tracked tissue and blood glucose values, respectively. This may enable patients with diabetes to monitor their glucose levels frequently, reliably, and most of all pain-free.
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Affiliation(s)
- Andreas Pfützner
- Pfützner Science & Health Institute,
Mainz, Germany
- Sciema UG, Mainz, Germany
- Technical University, Bingen,
Germany
- Andreas Pfützner, MD, PhD, Diabetes Center
& Practice, Pfützner Science & Health Institute, Parcusstr 8, Mainz,
D-55116, Germany.
| | | | - Filiz Demircik
- Pfützner Science & Health Institute,
Mainz, Germany
- Technical University, Bingen,
Germany
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Rao PV, Makkar BM, Kumar A, Das AK, Singh AK, Mithal A, Bhansali A, Misra A, Maheshwari A, Gupta A, Rustogi A, Saboo B, Vasanth Kumar CH, Anand Moses CR, Thacker H, Panda J, Jana J, Kesavdev J, Narasimha Setty KR, Chawla M, Deshpande N, Tandon N, Chawla R, Kovil R, Sahay R, Madhu SV, Banerjee S, Agarwal S, Kalra S, Bajaj S, Joshi SR, Aravind SR, Chowdhury S, Ghosh S, Gupta S, Mohan V, Panikar V, Viswanathan V. RSSDI consensus on self-monitoring of blood glucose in types 1 and 2 diabetes mellitus in India. Int J Diabetes Dev Ctries 2018; 38:260-279. [DOI: 10.1007/s13410-018-0677-3] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
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12
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Machry RV, Rados DV, Gregório GRD, Rodrigues TC. Self-monitoring blood glucose improves glycemic control in type 2 diabetes without intensive treatment: A systematic review and meta-analysis. Diabetes Res Clin Pract 2018; 142:173-187. [PMID: 29857093 DOI: 10.1016/j.diabres.2018.05.037] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/18/2017] [Revised: 04/29/2018] [Accepted: 05/22/2018] [Indexed: 11/15/2022]
Abstract
AIMS Systematic review and meta-analysis to evaluate the effect of Self-Monitoring of Blood Glucose (SMBG) on glycemic control in patients with type 2 Diabetes (T2D). METHODS We searched the Medline, Embase, Cochrane Central, and ClinicalTrials.gov databases up to 20 July 2017. We also performed a manual search of abstracts from recent meetings of the American Diabetes Association and the European Association for the Study of Diabetes. STUDY SELECTION randomized controlled trials (RCTs) conducted in patients with T2D comparing any kind of SMBG to a control group. Two independent reviewers assessed the eligibility of references. Influence of SMBG in glycated hemoglobin (HbA1c) was aggregated as weighted mean difference accessed by direct random effect meta-analyses at 12, 24 weeks and 1 year. Sub-analyses were made to assess the effects of previous glycemic control and number of tests performed. RESULTS SMBG was associated with a reduction of HbA1c at 12 weeks (-0.31%; 95% CI: -0.57 to -0.05) and 24 weeks (-0.34%; 95%CI: -0.52 to -0.17), but no difference was found for 1 year. Subgroup analysis including studies with baseline HbA1c greater than 8% showed a higher reduction of HbA1c: -0.83% (95% CI: -1.55 to -0.11) at 12 weeks, and -0.48% (95% CI: -0.77 to -0.19) at 24 weeks, with no difference for 1 year nor for the stratification for number the tests. CONCLUSION SMBG seems to lead to a slightly better glycemic control in the short term in patients with T2D. Patients decompensated at baseline appear to have the greatest benefit. PROSPERO register: CRD42016033558.
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Affiliation(s)
- Rafael Vaz Machry
- Post Graduate Program in Medical Sciences - Endocrinology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Department of Internal Medicine, Medical School, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.
| | - Dimitris Varvaki Rados
- Post Graduate Program in Medical Sciences - Endocrinology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Division of Internal Medicine, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
| | | | - Ticiana Costa Rodrigues
- Post Graduate Program in Medical Sciences - Endocrinology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Division of Endocrinology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Department of Internal Medicine, Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil
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14
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Kempf K, Altpeter B, Berger J, Reuß O, Fuchs M, Schneider M, Gärtner B, Niedermeier K, Martin S. Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care 2017; 40:863-871. [PMID: 28500214 DOI: 10.2337/dc17-0303] [Citation(s) in RCA: 88] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2017] [Accepted: 04/11/2017] [Indexed: 02/03/2023]
Abstract
OBJECTIVE Lifestyle interventions are the foundation of treatment in newly diagnosed type 2 diabetes. However, their therapeutic potential in advanced disease stages is unknown. We evaluated the efficacy of the Telemedical Lifestyle intervention Program (TeLiPro) in improving metabolic control in advanced-stage type 2 diabetes. RESEARCH DESIGN AND METHODS In this single-blind, active comparator, intervention study, patients with type 2 diabetes (with glycated hemoglobin [HbA1c] ≥7.5% [58.5 mmol/mol]), and BMI ≥27 kg/m2 and on ≥2 antidiabetes medications) were recruited in Germany and randomized 1:1 using an electronically generated random list and sealed envelopes into two parallel groups. The data analyst was blinded after assignment. The control group (n = 100) got weighing scales and step counters and remained in routine care. The TeLiPro group (n = 102) additionally received telemedical coaching including medical-mental motivation, a formula diet, and self-monitored blood glucose for 12 weeks. The primary end point was the estimated treatment difference in HbA1c reduction after 12 weeks. All available values per patient (n = 202) were analyzed. Analyses were also performed at 26 and 52 weeks of follow-up. RESULTS HbA1c reduction was significantly higher in the TeLiPro group (mean ± SD -1.1 ± 1.2% vs. -0.2 ± 0.8%; P < 0.0001). The estimated treatment difference in the fully adjusted model was 0.8% (95% CI 1.1; 0.5) (P < 0.0001). Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [95% CI 1.0; 0.3], P = 0.0001; week 52: 0.6% [0.9; 0.2], P < 0.001). The same applies for secondary outcomes: weight (TeLiPro -6.2 ± 4.6 kg vs. control -1.0 ± 3.4 kg), BMI (-2.1 ± 1.5 kg/m2 vs. -0.3 ± 1.1 kg/m2), systolic blood pressure (-5.7 ± 15.3 mmHg vs. -1.6 ± 13.8 mmHg), 10-year cardiovascular disease risk, antidiabetes medication, and quality of life and eating behavior (P < 0.01 for all). The effects were maintained long-term. No adverse events were reported. CONCLUSIONS In advanced-stage type 2 diabetes, TeLiPro can improve glycemic control and may offer new options to avoid pharmacological intensification.
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Affiliation(s)
- Kerstin Kempf
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany
| | - Bernd Altpeter
- German Institute for Telemedicine and Healthpromotion, Düsseldorf, Germany
| | - Janine Berger
- German Institute for Telemedicine and Healthpromotion, Düsseldorf, Germany
| | - Oliver Reuß
- Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany
| | | | - Michael Schneider
- Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.,Mannheim Institute for Public Health, Medical Faculty Mannheim, Ruprecht-Karls University Heidelberg, Mannheim, Germany
| | - Babette Gärtner
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany
| | - Katja Niedermeier
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany
| | - Stephan Martin
- West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany.,Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany
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15
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Teston EF, Arruda GOD, Sales CA, Serafim D, Marcon SS. Nursing appointment and cardiometabolic control of diabetics: a randomized clinical trial. Rev Bras Enferm 2017; 70:468-474. [DOI: 10.1590/0034-7167-2016-0352] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2016] [Accepted: 09/01/2016] [Indexed: 01/21/2023] Open
Abstract
ABSTRACT Objective: to verify the effect of nursing appointment on cardiometabolic profile of people with Diabetes Mellitus type 2. Method: randomized controlled trial, developed with 134 individuals chosen for two groups: intervention and control. The intervention consisted of three nursing appointments alternated bimonthly, with two phone calls, over five months. The control group received usual care offered by the Health Unit. Data were collected through semi-structured interviews before and after the intervention, in addition to conducting laboratory tests. Results: after the intervention, a significant difference was shown in the amount of glycated hemoglobin (p = 0.006) and in the systolic blood pressure (p = 0.031), which were higher in the control group. Conclusion: besides being low-cost and easy to develop on the monitoring routine of people with diabetes, the intervention performed influenced positively the biochemical profile.
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16
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Zhu H, Zhu Y, Leung SW. Is self-monitoring of blood glucose effective in improving glycaemic control in type 2 diabetes without insulin treatment: a meta-analysis of randomised controlled trials. BMJ Open 2016; 6:e010524. [PMID: 27591016 PMCID: PMC5020874 DOI: 10.1136/bmjopen-2015-010524] [Citation(s) in RCA: 52] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/03/2022] Open
Abstract
OBJECTIVE The present study aimed to verify the effectiveness of self-monitoring of blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes (T2D). METHODS A comprehensive literature search was conducted in PubMed, Cochrane Library, Web of Science, ScienceDirect and ClinicalTrials.gov from their respective inception dates to 26 October 2015. Eligible randomised controlled trials (RCTs) were included according to prespecified criteria. The quality of the included RCTs was evaluated according to the Cochrane risk of bias tool, and the evidence quality of meta-analyses was assessed by the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis of primary and secondary outcome measures was performed. Sensitivity and subgroup analyses were carried out to evaluate the robustness and heterogeneity of the findings. Begg's and Egger's tests were used to quantify publication biases. RESULTS A total of 15 RCTs, comprising 3383 patients with non-insulin-treated T2D, met the inclusion criteria. The SMBG intervention improved glycated haemoglobin (HbA1c) (mean difference -0.33; 95% CI -0.45 to -0.22; p=3.0730e-8; n=18), body mass index (BMI; -0.65; -1.18 to -0.12; p=0.0164; n=9) and total cholesterol (TC; -0.12; -0.20 to -0.04; p=0.0034; n=8) more effectively than the control in overall effect. The sensitivity analysis revealed little difference in overall effect, indicating the robustness of the results. SMBG moderated HbA1c levels better than the control in all subgroup analyses. Most of the RCTs had high risk of bias in blinding, while the overall quality of evidence for HbA1c was moderate according to the GRADE criteria. Publication bias was moderate for BMI. CONCLUSIONS SMBG improved HbA1c levels in the short term (≤6-month follow-up) and long term (≥12-month follow-up) in patients with T2D who were not using insulin. TRIAL REGISTRATION NUMBER CRD42015019099.
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Affiliation(s)
- Hongmei Zhu
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Yanan Zhu
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Siu-wai Leung
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
- School of Informatics, University of Edinburgh, Edinburgh, UK
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17
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Afable A, Karingula NS. Evidence based review of type 2 diabetes prevention and management in low and middle income countries. World J Diabetes 2016; 7:209-229. [PMID: 27226816 PMCID: PMC4873312 DOI: 10.4239/wjd.v7.i10.209] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2014] [Revised: 01/28/2016] [Accepted: 03/09/2016] [Indexed: 02/05/2023] Open
Abstract
AIM: To identify the newest approaches to type 2 diabetes (T2DM) prevention and control in the developing world context.
METHODS: We conducted a systematic review of published studies of diabetes prevention and control programs in low and middle-income countries, as defined by the World Bank. We searched PubMed using Medical Subject Headings terms. Studies needed to satisfy four criteria: (1) Must be experimental; (2) Must include patients with T2DM or focusing on prevention of T2DM; (3) Must have a lifestyle intervention component; (4) Must be written in English; and (5) Must have measurable outcomes related to diabetes.
RESULTS: A total of 66 studies from 20 developing countries were gathered with publication dates through September 2014. India contributed the largest number of trials (11/66). Of the total 66 studies reviewed, all but 3 studies reported evidence of favorable outcomes in the prevention and control of type 2 diabetes. The overwhelming majority of studies reported on diabetes management (56/66), and among these more than half were structured lifestyle education programs. The evidence suggests that lifestyle education led by allied health professionals (nurses, pharmacists) were as effective as those led by physicians or a team of clinicians. The remaining diabetes management interventions focused on diet or exercise, but the evidence to recommend one approach over another was weak.
CONCLUSION: Large experimental diabetes prevention/control studies of dietary and exercise interventions are lacking particularly those that consider quality rather than quantity of carbohydrates and alternative exercise.
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Elgart JF, González L, Prestes M, Rucci E, Gagliardino JJ. Frequency of self-monitoring blood glucose and attainment of HbA1c target values. Acta Diabetol 2016; 53:57-62. [PMID: 25841589 DOI: 10.1007/s00592-015-0745-9] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2014] [Accepted: 03/18/2015] [Indexed: 11/30/2022]
Abstract
AIMS Test strips for self-monitoring of blood glucose (SMBG) represent in Argentina, around 50 % of diabetes treatment cost; the frequency of their use is closely associated with hyperglycemia treatment. However, the favorable impact of SMBG on attainment of HbA1c goal in different treatment conditions remains controversial. We therefore attempted to estimate the relationship between use of SMBG test strips and degree of attainment of metabolic control in an institution of our social security subsector (SSS) in which provision is fully covered and submitted to a regular audit system. METHODS Observational retrospective study using information of 657 patients with T2DM (period 2009-2010) from the database of the Diabetes and Other Cardiovascular Risk Factors Program (DICARO) of one institution of our SSS. DICARO provides-with an audit system-100 % coverage for all drugs and keeps records of clinical, metabolic and treatment data from every patient. RESULTS The average monthly test strips/patient used for SMBG increased as a function of treatment intensification: Monotherapy with oral antidiabetic drugs (OAD) < combined OAD therapy < insulin treatment. In every condition, the number was larger in people with target HbA1c levels. Test strips represented the larger percentage of total prescription cost. CONCLUSIONS In our population, the type of hyperglycemia treatment was the main driver of test strip use for SMBG; in every condition tested, targeted HbA1c values were associated with greater strip use. Patient education and prescription audit may optimize its use and treatment outcomes.
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Affiliation(s)
- Jorge F Elgart
- CENEXA. Centro de Endocrinología Experimental y Aplicada (UNLP-CONICET LA PLATA, Centro Colaborador de la OPS/OMS en Diabetes), Facultad de Ciencias Médicas UNLP, 60 y 120, 1900, La Plata, Argentina.
| | - Lorena González
- CENEXA. Centro de Endocrinología Experimental y Aplicada (UNLP-CONICET LA PLATA, Centro Colaborador de la OPS/OMS en Diabetes), Facultad de Ciencias Médicas UNLP, 60 y 120, 1900, La Plata, Argentina.
- Escuela de Economía de la Salud y Administración de Organizaciones de Salud, Facultad de Ciencias Económicas, Universidad Nacional de La Plata (UNLP), La Plata, Argentina.
| | - Mariana Prestes
- CENEXA. Centro de Endocrinología Experimental y Aplicada (UNLP-CONICET LA PLATA, Centro Colaborador de la OPS/OMS en Diabetes), Facultad de Ciencias Médicas UNLP, 60 y 120, 1900, La Plata, Argentina.
| | - Enzo Rucci
- CENEXA. Centro de Endocrinología Experimental y Aplicada (UNLP-CONICET LA PLATA, Centro Colaborador de la OPS/OMS en Diabetes), Facultad de Ciencias Médicas UNLP, 60 y 120, 1900, La Plata, Argentina.
- III-LIDI, Facultad de Informática, Universidad Nacional de La Plata (UNLP), La Plata, Argentina.
| | - Juan J Gagliardino
- CENEXA. Centro de Endocrinología Experimental y Aplicada (UNLP-CONICET LA PLATA, Centro Colaborador de la OPS/OMS en Diabetes), Facultad de Ciencias Médicas UNLP, 60 y 120, 1900, La Plata, Argentina.
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Harashima SI, Nishimura A, Ikeda K, Wang Y, Liu Y, Inagaki N. Once Daily Self-Monitoring of Blood Glucose (SMBG) Improves Glycemic Control in Oral Hypoglycemic Agents (OHA)-Treated Diabetes: SMBG-OHA Follow-Up Study. J Diabetes Sci Technol 2015; 10:378-82. [PMID: 26428934 PMCID: PMC4773965 DOI: 10.1177/1932296815608869] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
BACKGROUND The aim of this study was to compare glycemic control between SMBG-continued and -discontinued subjects with type 2 diabetes in the SMBG-OHA study. METHOD Of the 96 subjects from the SMBG-OHA study, 59 were recruited for the 24-week, comparison follow-up study. The study outcomes were the differences in change in HbA1c levels at 24 weeks between the 2 groups, and change in SMBG frequency in SMBG-continued subjects. RESULTS Although health insurance does not cover the cost of SMBG, 22.0% of subjects continued SMBG of their own will after the SMBG-OHA study was completed. HbA1c levels were maintained from 6.81 ± 0.55% to 6.64 ± 0.53% in SMBG-continued subjects. Conversely, HbA1c levels were increased from 7.18 ± 0.63% to 7.48 ± 0.84% in SMBG-discontinued subjects. HbA1c levels were significantly different by 0.83 ± 0.25% (95% CI: -1.33 to -0.36). The difference in change in HbA1c between the groups was -0.46% (95% CI: -0.78 to -0.15). SMBG frequency was decreased from 2.02 ± 1.06 to 1.53 ± 0.86 times a day. CONCLUSIONS HbA1c levels were maintained in SMBG-continued subjects but increased in SMBG-discontinued subjects. The study implied that almost once daily SMBG is helpful to maintain glycemic control in non-insulin-treated type 2 diabetes.
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Affiliation(s)
- Shin-Ichi Harashima
- Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Akiko Nishimura
- Department of Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Kaori Ikeda
- Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Yu Wang
- Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Yanyan Liu
- Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Nobuya Inagaki
- Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan
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Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes. J Med Internet Res 2015. [PMID: 26199142 PMCID: PMC4527012 DOI: 10.2196/jmir.4112] [Citation(s) in RCA: 76] [Impact Index Per Article: 7.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022] Open
Abstract
Background Type 2 diabetes mellitus is a worldwide challenge. Practice guidelines promote structured self-monitoring of blood glucose (SMBG) for informing health care providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change. Paired glucose testing—pairs of glucose results obtained before and after a meal or physical activity—is a method of structured SMBG. However, frequent access to glucose data to interpret values and recommend actions is challenging. A complete feedback loop—data collection and interpretation combined with feedback to modify treatment—has been associated with improved outcomes, yet there remains limited integration of SMBG feedback in diabetes management. Incorporating telehealth remote monitoring and asynchronous electronic health record (EHR) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management—employ the complete feedback loop to improve outcomes. Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test. Methods A 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. Participants were aged 30-70 years, not using insulin with A1c levels between 7.5% and 10.9% (58-96 mmol/mol). The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly. CDEs called participants monthly to discuss paired glucose testing trends and treatment changes. Separate mixed-effects models were used to analyze data. Results Participants (N=90) were primarily white (64%, 56/87), mean age 58 (SD 11) years, mean body mass index 34.1 (SD 6.7) kg/m2, with diabetes for mean 8.2 (SD 5.4) years, and a mean A1c of 8.3% (SD 1.1; 67 mmol/mol). Both groups lowered A1c with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months (SE 0.08, t159=–2.87, P=.005). Change in medication (SE 0.21, t157=–3.37, P=.009) was significantly associated with lower A1c level. The treatment group significantly improved on the SDSCA subscales carbohydrate spacing (P=.04), monitoring glucose (P=.001), and foot care (P=.02). Conclusions An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A1c levels compared to usual care. Trial Registration Clinicaltrials.gov NCT01715649; https://www.clinicaltrials.gov/ct2/show/NCT01715649 (Archived by WebCite at http://www.webcitation.org/6ZinLl8D0).
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Affiliation(s)
- Deborah A Greenwood
- Clinical Performance Improvement Consultant, Office of Patient Experience, Quality and Clinical Effectiveness, Sutter Health, Sacramento, CA, United States.
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Dallosso HM, Bodicoat DH, Campbell M, Carey ME, Davies MJ, Eborall HC, Hadjiconstantinou M, Khunti K, Speight J, Heller S. Self-monitoring of blood glucose versus self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes receiving structured education: a cluster randomized controlled trial. Diabet Med 2015; 32:414-22. [PMID: 25308625 DOI: 10.1111/dme.12598] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/06/2014] [Indexed: 11/30/2022]
Abstract
AIMS To compare the effectiveness and acceptability of self-monitoring of blood glucose with self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes. METHODS We conducted a multi-site cluster randomized controlled trial with practice-level randomization. Participants attended a structured group education programme, which included a module on self-monitoring using blood glucose or urine glucose monitoring. HbA1c and other biomedical measures as well as psychosocial data were collected at 6, 12 and 18 months. A total of 292 participants with Type 2 diabetes were recruited from 75 practices. RESULTS HbA1c levels were significantly lower at 18 months than at baseline in both the blood monitoring group [mean (se) -12 (2) mmol/mol; -1.1 (0.2) %] and the urine monitoring group [mean (se) -13 (2) mmol/mol; -1.2 (0.2)%], with no difference between groups [mean difference adjusted for cluster effect and baseline value = -1 mmol/mol (95% CI -3, 2); -0.1% (95% CI -0.3, 0.2)]. Similar improvements were observed for the other biomedical outcomes, with no differences between groups. Both groups showed improvements in total treatment satisfaction, generic well-being, and diabetes-specific well-being, and had a less threatening view of diabetes, with no differences between groups at 18 months. Approximately one in five participants in the urine monitoring arm switched to blood monitoring, while those in the blood monitoring arm rarely switched (18 vs 1% at 18 months; P < 0.001). CONCLUSIONS Participants with newly diagnosed Type 2 diabetes who attended structured education showed similar improvements in HbA1c levels at 18 months, regardless of whether they were assigned to blood or urine self-monitoring.
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Affiliation(s)
- H M Dallosso
- University Hospitals of Leicester, Leicester Diabetes Centre, Leicester, UK
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Ruiz Gracia T, García de la Torre Lobo N, Durán Rodríguez Hervada A, Calle Pascual AL. Structured SMBG in early management of T2DM: Contributions from the St Carlos study. World J Diabetes 2014; 5:471-481. [PMID: 25126393 PMCID: PMC4127582 DOI: 10.4239/wjd.v5.i4.471] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/13/2014] [Revised: 04/11/2014] [Accepted: 05/29/2014] [Indexed: 02/05/2023] Open
Abstract
Diabetes mellitus type 2 (T2DM) is a global pandemic that will affect 300 million people in the next decade. It has been shown that early and aggressive treatment of T2DM from the onset decreases complications, and the patient’s active role is necessary to achieve better glycemic control. In order to achieve glycemic control targets, an active attitude in patients is needed, and self-monitoring of blood glucose (SMBG) plays a significant role. Nowadays, SMBG has become an important component of modern therapy for diabetes mellitus, and is even more useful if it is performed in a structured way. SMBG aids physicians and patients to achieve a specific level of glycemic control and to prevent hypoglycemia. In addition, SMBG empowers patients to achieve nutritional and physical activity goals, and helps physicians to optimize the different hypoglycemic therapies as demonstrated in the St Carlos study. This article describes the different ways of using this educational and therapeutic tool from the medical point of view as well as from the patient’s perspective.
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Steventon A, Bardsley M, Doll H, Tuckey E, Newman SP. Effect of telehealth on glycaemic control: analysis of patients with type 2 diabetes in the Whole Systems Demonstrator cluster randomised trial. BMC Health Serv Res 2014; 14:334. [PMID: 25100190 PMCID: PMC4128403 DOI: 10.1186/1472-6963-14-334] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2014] [Accepted: 07/23/2014] [Indexed: 12/27/2022] Open
Abstract
BACKGROUND The Whole Systems Demonstrator was a large, pragmatic, cluster randomised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of England. Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely. We examined whether telehealth led to changes in glycosylated haemoglobin (HbA1c) among the subset of patients with type 2 diabetes. METHODS The general practice electronic medical record was used as the source of information on HbA1c. Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period, and adjusted for differences in HbA1c readings recorded before recruitment. Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period. RESULTS 513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study. Telehealth was associated with lower HbA1c than usual care during the trial period (difference 0.21% or 2.3 mmol/mol, 95% CI, 0.04% to 0.38%, p = 0.013). Among the 457 patients in the secondary analysis, mean HbA1c showed little change for controls following recruitment, but fell for intervention patients from 8.38% to 8.15% (68 to 66 mmol/mol). A higher proportion of intervention patients than controls had HbA1c below the 7.5% (58 mmol/mol) threshold that was targeted by general practices (30.4% vs. 38.0%). This difference, however, did not quite reach statistical significance (adjusted odds ratio 1.63, 95% CI, 0.99 to 2.68, p = 0.053). CONCLUSIONS Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months. The scale of the improvements is consistent with previous meta-analyses, but was relatively modest and seems unlikely to produce significant patient benefit. TRIAL REGISTRATION NUMBER International Standard Randomized Controlled Trial Number Register ISRCTN43002091.
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Czupryniak L, Barkai L, Bolgarska S, Bronisz A, Broz J, Cypryk K, Honka M, Janez A, Krnic M, Lalic N, Martinka E, Rahelic D, Roman G, Tankova T, Várkonyi T, Wolnik B, Zherdova N. Self-monitoring of blood glucose in diabetes: from evidence to clinical reality in Central and Eastern Europe--recommendations from the international Central-Eastern European expert group. Diabetes Technol Ther 2014; 16:460-75. [PMID: 24716890 PMCID: PMC4074758 DOI: 10.1089/dia.2013.0302] [Citation(s) in RCA: 47] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Self-monitoring of blood glucose (SMBG) is universally considered to be an integral part of type 1 diabetes management and crucial for optimizing the safety and efficacy of complex insulin regimens. This extends to type 2 diabetes patients on intensive insulin therapy, and there is also a growing body of evidence suggesting that structured SMBG is beneficial for all type 2 diabetes patients, regardless of therapy. However, access to SMBG can be limited in many countries in Central and Eastern Europe. A consensus group of diabetes experts from 10 countries in this region (with overlapping historical, political, and social environments)--Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovakia, Slovenia, and Ukraine--was formed to discuss the role of SMBG across the spectrum of patients with diabetes. The group considered SMBG to be an essential tool that should be accessible to all patients with diabetes, including those with non-insulin-treated type 2 diabetes. The current article summarizes the evidence put forward by the consensus group and provides their recommendations for the appropriate use of SMBG as part of individualized patient management. The ultimate goal of these evidence-based recommendations is to help patients and providers in Central and Eastern Europe to make optimal use of SMBG in order to maximize the efficacy and safety of glucose-lowering therapies, to prevent complications, and to empower the patient to play a more active role in the management of their diabetes.
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Affiliation(s)
- Leszek Czupryniak
- Internal Medicine and Diabetology Department, Medical University of Lodz, Lodz, Poland
| | - László Barkai
- Postgraduate Institute of Pediatrics, Medical and Health Science Center, University of Debrecen, Debrecen, Hungary
- Department of Theoretical Health Sciences, Faculty of Health Care, University of Miskolc, Miskolc, Hungary
| | - Svetlana Bolgarska
- Department of Diabetology, National Medical Academy of Post-Graduate Education, Institute of Endocrinology and Metabolism of National Academy of Medical Science, Kiev, Ukraine
| | - Agata Bronisz
- Department of Endocrinology and Diabetology, Nicolaus Copernicus University in Toruń, Toruń, Poland
- Ludwik Rydygier Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland
| | - Jan Broz
- Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic
- Faculty Hospital Motol, Prague, Czech Republic
| | - Katarzyna Cypryk
- Department of Diabetology and Metabolic Diseases, Medical University of Lodz, Lodz, Poland
| | - Marek Honka
- Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic
- Faculty Hospital Motol, Prague, Czech Republic
| | - Andrej Janez
- Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Center, Ljubljana, Slovenia
| | | | - Nebojsa Lalic
- Department for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
| | - Emil Martinka
- National Institute for Endocrinology and Diabetology, Lubochna, Slovakia
| | - Dario Rahelic
- Department of Endocrinology, Diabetes and Metabolic Disorders, Dubrava University Hospital, Zagreb, Croatia
| | - Gabriela Roman
- Iuliu Hatieganu University of Medicine & Pharmacy, Clinical Center of Diabetes, Nutrition, Metabolic Diseases, Cluj-Napoca, Romania
| | | | - Tamás Várkonyi
- First Department of Internal Medicine, University of Szeged, Szeged, Hungary
| | - Bogumił Wolnik
- Department of Hypertension and Diabetology, Medical University of Gdańsk, Gdańsk, Poland
| | - Nadia Zherdova
- Department of Diabetology, National Medical Academy of Post-Graduate Education, Institute of Endocrinology and Metabolism of National Academy of Medical Science, Kiev, Ukraine
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Alzaid A, Schlaeger C, Hinzmann R. 6(th) Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) applications and beyond, April 25-27, 2013, Riga, Latvia. Diabetes Technol Ther 2013; 15:1033-52. [PMID: 24074038 PMCID: PMC3868282 DOI: 10.1089/dia.2013.0260] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/12/2022]
Abstract
International experts in the fields of diabetes, diabetes technology, endocrinology, and pediatrics gathered for the 6(th) Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and beyond. The aim of this meeting was to continue setting up a global network of experts in this field and provide an international platform for exchange of ideas to improve life for people with diabetes. The 2013 meeting comprised a comprehensive scientific program, parallel interactive workshops, and two keynote lectures. All these discussions were intended to help identify gaps and areas where further scientific work and clinical studies are warranted.
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Affiliation(s)
- Aus Alzaid
- Prince Sultan Military Medical City, Riyadh, Saudi Arabia
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