Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

Обзор

This single-arm interventional study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation. From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments. The primary objective is to measure the percentage of time spent in the target pregnancy glucose range (63-140 mg/dL). Secondary outcomes track mean glucose, HbA1c, and overall maternal and neonatal health to ensure safety and efficacy.

Подробное описание

This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.

This is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.

Participants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.

The main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg/dL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.

This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.

This is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.

Participants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.

The main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg/dL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.

Вмешательства

• Устройство Automated insulin delivery system - Medtronic 780G
  Use of automated insulin delivery system in pregnant patients with type 2 diabetes

Первичные конечные точки

• Time in range [Срок оценки: From enrollment to the delivery]
• Mean sensor glycemia [Срок оценки: From enrollment to the delivery]

Вторичные конечные точки (12)

• Time in range [Срок оценки: Week 18]
• Time in range [Срок оценки: Week 22]
• Time in range [Срок оценки: Week 26]
• Time in range [Срок оценки: Week 30]
• Time in range [Срок оценки: Week 34]
• Time in range [Срок оценки: Week 37]
• Time in tight range [Срок оценки: Week 18]
• Time in tight range [Срок оценки: Week 22]
• Time in tight range [Срок оценки: Week 26]
• Time in tight range [Срок оценки: Week 30]
• Time in tight range [Срок оценки: Week 34]
• Time in tight range [Срок оценки: Week 37]

Критерии участия

Критерии включения

• Women with diagnosed pregestational type 2 diabetes or HbA1c >6.5% in the 1st trimester (ADA, PTD)
• Age 18-45 years
• Gestational age of 16 weeks +0 days or less at baseline
• Singleton pregnancy
• HbA1c at baseline 5.0-10%
• A viable pregnancy at the recruitment
• Willingness to continue the treatment until delivery in the clinic

Критерии исключения

• Other types of diabetes including T1D and Monogenic diabetes
• Major fetal congenital defects
• Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial
• Pump therapy before pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Польша · 1 центр

• Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Med — Poznan

Публикации

• Gladych-Macioszek A, Mantaj U, Tobola-Wrobel K, Radzicka-Mularczyk S, Sibiak R, Adamczak L, Desoye G, Wender-Ozegowska E. Early gestational diabetes mellitus and type 2 diabetes: do they differ in perinatal outcome- a retrospective analysis. BMC Pregnancy Childbirth. 2026 Mar 11;26(1):423. doi: 10.1186/s12884-026-08927-3. PMID 41807957
• Sibiak R, Iciek R, Gastolek K, Chudzynska E, Meek C, Wender-Ozegowska E. Ten-year national trends in the prevalence and outcomes of gestational diabetes mellitus in Poland: a population-based study. Pol Arch Intern Med. 2026 Feb 26;136(2):17202. doi: 10.20452/pamw.17202. Epub 2026 Jan 19. PMID 41562177

Идентификаторы

NCT: NCT07602036 · 599_25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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