Table 1.

Key randomised controlled trials of closed-loop insulin delivery using commercialised systems.

Closed-loop system	Type of study	Comparator	Duration	Population	Baseline HbA1c	Glycaemic outcomes			Closed-loop usage
						TIR	TBR	HbA1c
670G HCL [39]	Randomised, parallel	Usual care (MDI or pump)	6 months	n=120 adults	58mmol/mol [7.5%]	↑ 15 percentage points to 70% [vs 55% control]	↓ to 1.8% [vs 3.8% control]	↓ to 7.0% [vs 7.4% control]	Median 89%
670G HCL [41]	Randomised, parallel	Usual care (MDI or pump)	6 months	n=172 children, adolescents and young adults (12–25 years)	64mmol/mol [8.0%]	↑ 6.7 percentage points to 63% [vs 56% control]	↓ to 2.2% [vs 4.1% control]	↓ to 7.5% [vs 7.6% control]	Not stated
780G AHCL [42]	Randomised, crossover	670G HCL	3 months	n=113 adolescents and young adults (14–29 years)	63mmol/mol [7.9%]	↑to 67% [vs 63% 670G HCL]	↔at 2.1% [vs 2.1% 670G HCL]	↓ to 7.4% [vs 7.6% 670G HCL]	Median 75% [HCL] 86% [AHCL]
780G AHCL [44]	Randomised, crossover	670G PLGM	4 weeks	n=59 children and adults (7–80 years)	60mmol/mol [7.6%]	↑ 13 percentage points to 70% [vs 60% PLGM]	↓ to 2.1% [vs 2.5% PLGM]	Not measured due to short study duration	Mean 96%
Control-IQ [47]	Randomised, parallel	SAP therapy	6 months	n=168 (14+ years)	57mmol/molbr] [7.4%]	↑ 11 percentage points to 70% [vs 59% SAP]	↓ to 1.6% [vs 2.3% SAP]	↓ to 7.1% [vs 7.4% SAP]	Median 90%
Control-IQ [48]	Randomised, parallel	SAP therapy	4 months	n=101 children (6–13 years)	60 – 63mmol/mol [7.6 – 7.9%]	↑ 11 percentage points to 67% [vs 55% SAP]	Similar between groups [1.6% vs 1.8% SAP]	↓ to 7.0% [vs 7.6% SAP] but this change was not statistically significant	Median 93%
Cambridge closed-loop [CamAPS FX] [56]	Randomised, crossover	HCL with faster insulin aspart (Fiasp)	2 months	n=25 adults	57mmol/mol [7.4%]	Not different between HCL with fiasp vs HCL with aspart [75% for both]	↓ in HCL with fiasp vs aspart [2.4% vs 2.9%]	HbA1c not measured due to short study duration	Median 95% (Fiasp) and 96% (Aspart)
Cambridge closed-loop [CamAPS FX] [55]	Randomised, parallel	Insulin pump therapy	6 months	n=46 children (6–18 years)	67 to 68mmol/mol [8.2 – 8.3%]	↑ 12 percentage points to 63% [vs 49% control]	Similar between groups [10.8% vs 6.3% control]	↓ to 6.8% [vs 7.9% control]	Median 93%
Cambridge closed-loop [CamAPS FX] [20]	Randomised, crossover	SAP therapy	4 months	n=74 children (1–7 years)	57mmol/mol [7.3%]	↑ 9 percentage points to 72% (vs 63% control]	Similar between groups [4.9% vs 4.5% control]	↓ to 6.6% [vs 7.0% control]	Median 95%
DBLG1 [57]	Randomised, crossover	SAP therapy	3 months	n=68 adults	59mmol/mol [7.6%]	↑ 9 percentage points to 69% [vs 59% SAP]	↓ to 2.0% [vs 4.3% SAP]	HbA1c significantly decreased in HCL, absolute values not available	Median 84%
DBLG1 [59]	Randomised, crossover, non-inferiority	SAP therapy	6 weeks	n=17 children (6–12 years)	Not stated	↑ to 66% [vs 59% SAP]	↓ to 2.6% [vs 5.2% SAP]	HbA1c not measured due to short study duration	Not stated

HCL – hybrid closed-loop. AHCL – advanced hybrid closed-loop. PLGM – predictive low glucose management. SAP – sensor-augmented pump. TIR – time in range (3.9–10.0mmol/L). TBR – time below range (<3.9mmol/L). HbA1c – glycated haemoglobin.