Role of automated insulin delivery in managing insulin-treated outpatients with type 2 diabetes: A systematic review and meta-analysis

Table 1 Baseline characteristics of individual randomized trials and study participants included in the meta-analysis

Ref.	Trial design, Trial reg number	Major inclusion criteria	Groups	Interventions	Number	Age (years), mean ± SD	HbA1c (%), mean ± SD	Diabetes duration (years), mean ± SD/median (interquartile range)	Key outcomes	Duration
Borel et al[23], 2024, three hospitals in France	Cross-over, NCT05369871	Age > 18 years, body weight ≤ 150 kg, insulin pump for ≥ 6 months, equipped with a CGM or flash glucose monitoring system, TDDI < 160 U/24 hours, and HbA1c < 10%	AID	DBLG1 hybrid closed-loop system (Accu-Chek Insight insulin pump, DexcomG6 CGM system and Diabeloop application)	17	63 ± 9	7.9 ± 0.9	24 ± 9	TIR, TAR, TBR, coefficient of glucose variation, TDDI, glucose management indicator	13 weeks (including two therapy: 6 weeks therapy of hybrid closed loop and 6 weeks of CSII + CGM)
			Control	Usual insulin pump therapy equipped with a DexcomG6 CGM system (CSII + CGM)	17
Boughton et al[24], 2021, two centers in United Kingdom and Switzerland	Cross-over, NCT04025775	Age ≥ 18 years, subcutaneous insulin therapy and end-stage renal disease requiring maintenance dialysis (hemodialysis or peritoneal dialysis)	AID	CamAPS HX closed-loop app (CamDiab) (Dana Diabecare RS pump, Dexcom G6 CGM system and Cambridge adaptive model predictive control algorithm, version 0.3.71)	26	68.3 ± 11.2	7.2 ± 1.3	20 ± 10	TIR, TAR, TBR, coefficient of glucose variation, TDDI, AEs	40 days (two therapy: 20 days therapy of closed loop and standard insulin therapy)
			Control	Standard subcutaneous insulin therapy with masked CGM	26
Daly et al[25], 2023, two centers in United Kingdom	Cross-over, NCT04701424	Age ≥ 18 years, subcutaneous insulin therapy, HbA1c ≤ 11%	AID	CamAPS HX Closed-loop (Dana insulin pump, Dexcom G6 real-time CGM system, and CamAPS HX Application v.0.3.71)	26	59 ± 11	9.0 ± 1.4	17.5 ± 8.2	TIR, TAR, TBR, HbA1c, mean sensor glucose, coefficient of glucose variation, TDDI, AEs	16 weeks (two therapy: 8 weeks therapy of closed loop and standard insulin therapy)
			Control	MDI and Dexcom G6 CGM system	26
Kudva et al[26], 2025, 21 centers in the United States and Canada	Parallel group, NCT05785832	Age ≥ 18 years, T2D ≥ 6 months. On MDI or insulin pump for ≥ 3 months1	AID	T: Slim X2 insulin pump with CIQ + technology (Tandem) and Dexcom G6 CGM system	215	59 ± 12	8.2 ± 1.4	18 (11-26)	HbA1c, TIR, TAR, TBR, AEs	13 weeks
			Control	Pretrial insulin delivery regimen and Dexcom G6 CGM system	104	57 ± 12	8.1 ± 1.2	18 (11-24)
Reznik et al[27], 2014, 36 centers in Canada, Europe, Israel, South Africa, and the United States	Parallel group, NCT01182493	Age 30-75 years, on MDI, TDDI ≤ 220 U/24 hours, HbA1c 8%-12%, ≥ 2.5 SMBG/day on average	AID	Medtronic MiniMed Paradigm Veo system; Medtronic	168	55.5 ± 9.7	9.0 ± 0.8	14.9 ± 8	HbA1c, mean 24-hour glucose concentrations, area under the curve for hypoglycaemia and hyperglycaemia, TAR, TBR, AEs	6 months
			Control	MDI with SMBG	163	56.4 ± 9.5	9.0 ± 0.8	15.3 ± 8
Reznik et al[28], 2024, muti-center in France	Parallel group, NCT04233229	Age > 18 years, T2D ≥ 6 months. On MDI ≥ 6 months. Requiring nursing support at home, HbA1c 8%-12%	AID	T: Slim X2 insulin pump with CIQ technology (Tandem) and Dexcom G6 CGM system	14	69.3 ± 6.7	9.0 ± 1.2	20.4 ± 12.3	TIR, TAR, TBR, coefficient of glucose variation, HbA1c, TDDI, body weight, body mass index, AEs	12 weeks
			Control	MDI with SMBG (from day 70 onwards, Dexcom G6 CGM until the planned completion of the study at day 90)	15	69.7 ± 10.3	9.25 ± 1.0	17.0 ± 9.05

¹In both groups, 96% were on multiple daily insulin injection and 4% were on an insulin pump.

AEs: Adverse events; AID: Automated insulin delivery; CGM: Continuous glucose monitoring; CIQ: Control-IQ; CSII: Continuous subcutaneous insulin infusion; HbA1c: Glycated hemoglobin; MDI: Multiple daily insulin injection; SMBG: Self-monitoring of blood glucose; TAR: Time above range; TBR: Time below range; TDDI: Total daily dose of insulin; TIR: Time in range; T2D: Type 2 diabetes.