Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial

Daly, AB; Boughton, CK; Nwokolo, M; Hartnell, S; Wilinska, ME; Cezar, A; Evans, ML; Hovorka, R

doi:10.1038/s41591-022-02144-z

Diabetes technology

Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial

Nat MedPublished 11 Jan 2023Randomised crossover trial

Primary result · TIR 3.9-10.0 mmol/lResultMean difference 35.3 percentage points 95% CI 28.0–42.6

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Authors' conclusion

Fully closed-loop insulin delivery improved glucose control without increasing hypoglycemia compared with standard insulin therapy

Study context

Population: Adults with T2D (7 women, 19 men; mean age 59 ± 11 years; baseline HbA1c 75 ± 15 mmol/mol (9.0% ± 1.4%))28 randomized
Participants: 26 adults

Comparison: CamAPS HX fully closed-loop app vs standard insulin therapy with masked glucose sensor (control)
Primary endpoint: Proportion of time in target glucose range (3.9-10.0 mmol/l)
Follow-up: 8-week periods

Methodological detailsopen-label, single-centre, two 8-week periods, 2-week to 4-week washout, Recruited 16 December 2020 to 24 November 2021; 30 recruited, 28 randomized (14 closed-loop first, 14 control first)

Open-label
Single-centre
Two 8-week periods
2-week to 4-week washout
Recruited 16 December 2020 to 24 November 2021; 30 recruited, 28 randomized (14 closed-loop first, 14 control first)

Primary result

TIR 3.9-10.0 mmol/l

Mean difference

35.3 percentage points

95% CI 28.0–42.6

P < 0.001

By group

Closed-loop66.3%mean · SD 14.9%

Control32.3%mean · SD 24.7%

Closed-loopvs Control

mean difference 35.3 percentage points (95% CI 28.0–42.6); P < 0.001

As reported in the abstract

Further findings

Outcome	Closed-loop	Control	← Lower with closed-loop ←→ Higher with closed-loop →	Mean difference (percentage points) (95% CI)	P value
Time >10.0 mmol/l	33.2% (SD 14.8%)	67.0% (SD 25.2%)	−60−40−20020	−35.2 (−42.8 to −27.5)	P < 0.001
			−60−40−20020Difference, percentage points (linear scale)

Mmol l-1

Outcome	Closed-loop	Control	← Lower with closed-loop ←→ Higher with closed-loop →	Mean difference (mmol l-1) (95% CI)	P value
Mean glucose	9.2 (SD 1.2)	12.6 (SD 3.0)	−6−4−202	−3.6 (−4.6 to −2.5)	P < 0.001
			−6−4−202Difference, mmol l-1 (linear scale)

HbA1c · end of period

mean difference (mmol mol-1) −15 (−11 to −20) · P < 0.001

Closed-loop57 mmol mol-1SD 9

Control72 mmol mol-1SD 13

HbA1c % Closed-loop 7.3% ± 0.8% · Control 8.7% ± 1.2%

HbA1c: estimate outside printed interval order; % MD −1.4 (95% CI −1.0 to −1.8)

Safety

Median

Outcome	Closed-loop	Control	P value
Time <3.9 mmol/lSimilar between treatments	0.44% (IQR 0.19–0.81%)	0.08% (IQR 0.00–1.05%)	P = 0.43

Severe hypoglycaemia and SAEs

Severe hypoglycemia events in either period: 0
Treatment-related serious adverse event during closed-loop period: 1

Original publication

Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial. Nat Med. Published 11 January 2023. doi:10.1038/s41591-022-02144-z

Read the original article ↗

Composed by AI from the published abstract and checked against it. How Briefs are made →