Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes

Lee, TTM; Collett, C; Bergford, S; Hartnell, S; Scott, EM; Lindsay, RS; Hunt, KF; McCance, DR; Barnard-Kelly, K; Rankin, D; Lawton, J; Reynolds, RM; Flanagan, E; Hammond, M; Shepstone, L; Wilinska, ME; Sibayan, J; Kollman, C; Beck, R; Hovorka, R; Murphy, HR; AiDAPT Collaborative Group

doi:10.1056/nejmoa2303911

Gestational diabetes & diabetes in pregnancy

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes

N Engl J MedPublished 5 Oct 2023Randomised controlled trial

Primary result · % time in target glucose rangeResultMean adjusted difference 10.5 percentage points 95% CI 7.0–14.0

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Authors' conclusion

Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes.

Study context

Population: Pregnant women with T1D and HbA1c ≥6.5%, 9 UK sites; mean age 31.1±5.3 years, mean baseline HbA1c 7.7±1.2%
Participants: 124 women

Comparison: Hybrid closed-loop therapy vs standard insulin therapy, both with CGM
Primary endpoint: % time in pregnancy-specific target glucose range (63–140 mg/dL [3.5–7.8 mmol/L]) by CGM
Follow-up: 16 weeks' gestation until delivery

Methodological detailsmulticentre

Multicentre

Primary result

% time in target glucose range

Mean adjusted difference

10.5 percentage points

95% CI 7.0–14.0

P < 0.001

By group

Closed-loop68.2mean · SD 10.5 · %

Standard care55.6mean · SD 12.5 · %

Closed-loopvs Standard care

mean adjusted difference 10.5 percentage points (95% CI 7.0–14.0); P < 0.001

As reported in the abstract

Secondary outcomes

Outcome	← Lower with closed-loop ←→ Higher with closed-loop →	Difference (percentage points) (95% CI)
% time hyperglycaemic (>140 mg/dL)	−20−1001020	−10.2 (−13.8 to −6.6)
Overnight time in target range	−20−1001020	12.3 (8.3–16.2)
HbA1c	−20−1001020	−0.31 (−0.50 to −0.12)
	−20−1001020Difference, percentage points (linear scale)

Safety

Outcome	Closed-loop	Standard care
Safety events
Severe hypoglycaemia	6	5
DKA	1	1
Device-related adverse events	12	— not stated in the abstract
Related to closed-loop therapy	7	— not stated in the abstract

— not stated in the abstract

Safety events

No unanticipated safety problems with closed-loop therapy; little time spent hypoglycaemic

Original publication

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes. N Engl J Med. Published 5 October 2023. doi:10.1056/nejmoa2303911

Read the original article ↗

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