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HAMBURG, Germany — Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy in people with type 1 diabetes, providing a clinical advantage beyond that achieved with continuous glucose monitoring (CGM) and insulin-pump therapy, shows the AiDAPT randomized controlled trial.

The results were presented for the first time at this year’s European Association for the Study of Diabetes (EASD) meeting and published simultaneously in The New England Journal of Medicine (NEJM).

“The importance of these findings cannot be understated,” said Satish K. Garg, M.D., and Sarit Polsky, M.D., from the Davis Center for Diabetes at the University of Colorado, Denver, quetiapine fumarate prescribed for sleep who wrote the editorial accompanying the study.  “Clearly, closed-loop systems have changed the landscape of diabetes care in nonpregnant populations…the AiDAPT trial provides hope that this landscape may also be altered for the better for pregnant persons with type 1 diabetes,” they write.

Helen Murphy, MD, consultant diabetologist at Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK, led the study and presented the work. She reported that time within the pregnancy-specific target glucose range was significantly higher in women in the closed-loop group than those on standard of care. Four times as many women in the closed-loop group as the standard of care group met the goal of 70% of time in the pregnancy-specific target glucose range, without any increase in hypoglycemia.

Of note, Murphy drew attention to the positive effect the system had mentally, as well as physically, on the mothers across their pregnancy. “Some said they could stay in work, for example one was in [the] hospitality [industry] and it [the hybrid closed loop] meant she could stay in paid employment for longer and this made a huge difference to her. Others said their partners could stay away from home overnight because they were no longer afraid of dying of hypoglycemia,” she said.

In comparison to the standard of care arm (standard insulin therapy with CGM), those in the closed-loop group were within the pregnancy-specific target glucose range for an extra 10.5% of the time (P < .001), a finding that was clinically significant. 

Moderating the session were Alexandra Kautzky-Willer, MD, from the Medical University of Vienna, Austria, and Fidelma Dunne, MD, professor in medicine at the National University of Ireland. “These results indicate a significant step forward in the clinical care of pregnant women with type 1 diabetes,” said Kautzky-Willer, adding that, “this randomized clinical trial is very important showing that using hybrid closed-loop systems during pregnancy can essentially increase the pregnancy-specific time in target without higher rates of hypoglycemic episodes. Of note, the glucose control during night-time and early morning markedly improved using [the] hybrid closed-loop system.”

Dunne congratulated the researchers on their work, highlighting that, “This rigorously conducted trial is a leap forward in the control of glucose in pregnant women with type 1 diabetes. This is strong evidence that hybrid closed loop should become the standard of care for all pregnant women with type 1 diabetes.”

Difference of 10.5% Points for Time in Range

The multicenter, controlled trial was carried out across nine UK hospitals and randomly assigned 124 pregnant women with type 1 diabetes and an A1c of at least 6.5% to receive standard insulin therapy (n = 63) or hybrid closed-loop therapy (n = 61), with both groups using CGM (Abbott FreeStyle Libre, Dexcom, Medtronic).

Essentially, the trial investigated the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg/dL [3.5 to 7.8 mmol/L]) as measured by CGM from 16 weeks’ gestation until delivery. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level >140 mg/dL), overnight time in the target range, the A1c level, and safety events.  Women had an average age of 31 years, baseline A1c of 7.7, median week of gestation at randomization 11 weeks, and 56%–57% had experienced diabetes complications in the past (retinopathy 56%).

The mean percentage of time that the maternal glucose level was in the target range was 68.2 ± 10.5% in the closed-loop group and 55.6 ± 12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points (95% CI, 7.0 – 14.0; P < .001) according to intent to treat analysis, and 12% (95% CI, 8% – 15%) difference by per protocol analysis (P < .001).

The percentage of time spent in the target range during the overnight period was similar to the 24-hour results (mean difference, 12.3 percentage points; 95% CI, 8.3 – 16.2).  And, 28 participants (47%) in the closed loop group and 7 (11%) in the standard-care group spent more than 70% of each day (16 hours 48 minutes) within the pregnancy-specific target glucose range, reported the researchers.

“These women had better results around glycemia, managing their own diabetes without significant weight gain,” remarked Tara Lee, MBBS, obstetrician at Norfolk and Norwich University Hospitals and first author of the NEJM paper. “Some women worry about gaining a lot of weight if they have more insulin, and that this adds to their obstetric complications, but we found this wasn’t the case.” Maternal weight gain was 11.1 kg +/- 6.1 in the closed-loop patients and 14.1 kg +/-6.1 for women on standard of care. (P = .02).

Gestational age of delivery was 4 to 4.5 days earlier in the closed loop group compared with the standard of care group. “This needs more exploration but importantly the neonatal outcomes show no difference in complications for example, respiratory distress, hypoglycemia,” added Lee.

The study was supported by the Efficacy and Mechanism Evaluation (EME) Program, an MRC and NIHR partnership; the Juvenile Diabetes Research Foundation; and the Diabetes Research & Wellness Foundation Sutherland-Earl Clinical Fellowship. Disclosure forms provided by the authors and editorialists are available with the full text of the study and the editorial at 

New Engl J Med. Published online October 5, 2023. Abstract, Editorial

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