Type 2 Diabetes and Pregnancy a Single-arm Interventional Study (pUMPreg2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Type 2 Diabetes
• Intervention / Treatment: Device: Automated insulin delivery system - Medtronic 780G

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ewa Wender-Ozegowska, Prof. MD PhD; Phone Number: +48 (61) 841-93-02; Email: ewozegow@ump.edu.pl

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 60-535
      • Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
      • Contact: Ewa Wender-Ozegowska, Prof. MD PhD; Phone Number: +48 (61) 841-93-02; Email: ewozegow@ump.edu.pl
      • Principal Investigator: Ewa Wender-Ozegowska, Prof. MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 2 diabetes; Pregnant patients with type 2 diabetes treated with automated insulin delivery system	Device: Automated insulin delivery system - Medtronic 780G; Use of automated insulin delivery system in pregnant patients with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	From enrollment to the delivery
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	From enrollment to the delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	Week 18
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	Week 22
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	Week 26
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	Week 30
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	Week 34
Time in range	Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	Week 37
Time in tight range	Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)	Week 18
Time in tight range	Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)	Week 22
Time in tight range	Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)	Week 26
Time in tight range	Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)	Week 30
Time in tight range	Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)	Week 34
Time in tight range	Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)	Week 37
Change in the time in range values	Change in percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)	From the recruitment to delivery
Time above range	Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)	Week 18
Time above range	Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)	Week 22
Time above range	Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)	Week 26
Time above range	Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)	Week 30
Time above range	Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)	Week 34
Time above range	Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)	Week 37
Time above tight range	Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)	Week 18
Time above tight range	Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)	Week 22
Time above tight range	Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)	Week 26
Time above tight range	Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)	Week 30
Time above tight range	Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)	Week 34
Time above tight range	Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)	Week 37
Time below range	Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)	Week 18
Time below range	Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)	Week 22
Time below range	Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)	Week 26
Time below range	Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)	Week 30
Time below range	Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)	Week 34
Time below range	Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)	Week 37
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	Week 18
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	Week 22
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	Week 26
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	Week 30
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	Week 34
Mean sensor glycemia	Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)	Week 37
Coefficient of variation (%CV)	Metric of glycemic variability measured by the sensor (%)	Week 18
Coefficient of variation (%CV)	Metric of glycemic variability measured by the sensor (%)	Week 22
Coefficient of variation (%CV)	Metric of glycemic variability measured by the sensor (%)	Week 26
Coefficient of variation (%CV)	Metric of glycemic variability measured by the sensor (%)	Week 30
Coefficient of variation (%CV)	Metric of glycemic variability measured by the sensor (%)	Week 34
Coefficient of variation (%CV)	Metric of glycemic variability measured by the sensor (%)	Week 37
Standard deviation (SD)	Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)	Week 18
Standard deviation (SD)	Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)	Week 22
Standard deviation (SD)	Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)	Week 26
Standard deviation (SD)	Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)	Week 30
Standard deviation (SD)	Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)	Week 34
Standard deviation (SD)	Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)	Week 37
HbA1C	Blood glycated hemoglobin measurement (% and mmol/mol)	Week 18
HbA1C	Blood glycated hemoglobin measurement (% and mmol/mol)	Week 22
HbA1C	Blood glycated hemoglobin measurement (% and mmol/mol)	Week 26
HbA1C	Blood glycated hemoglobin measurement (% and mmol/mol)	Week 30
HbA1C	Blood glycated hemoglobin measurement (% and mmol/mol)	Week 34
HbA1C	Blood glycated hemoglobin measurement (% and mmol/mol)	Week 37
Severe hypoglycemia episodes	Number of episodes of self-reported severe hypoglycemia.	From recruitment until delivery.
Gestational weight gain	Maternal gestational weight gain (kg)	From recruitment until delivery
Gestational weight gain from pre-pregnancy	Self-reported maternal gestational weight gain (kg)	From pre-pregnancy until delivery
Pregnancy hypertensive disorders	Preeclampsia, Eclampsia, Gestational hypertension	From recruitment until delivery
The mode of delivery	Vaginal, c-section, spontaneous, induction of labor	At delivery
Birth trauma	IADPSG criteria	At delivery
Gestational birth weight	Neonatal birth weight in grams	At delivery
Macrosomia	Gestational birth weight >4200g	At delivery
Large-for-gestational-age (LGA)	Neonatal birth weight >90th percentile	At delivery
Small-for-gestational-age (SGA)	Neonatal birth weight >10th percentile	At delivery
Placental weight	Measured in grams	At delivery
Gestational age	Timing of delivery	At delivery
Preterm birth	<37 weeks	At delivery
Number of neonates with respiratory distress syndrome	Defined as the number of neonates diagnosed with respiratory distress syndrome during the postnatal hospital stay, based on clinical signs of respiratory distress and the need for respiratory support, with or without radiological confirmation, according to local neonatal clinical practice.	From delivery until hospital discharge, assessed up to 20 weeks postpartum
Number of neonates with jaundice requiring phototherapy	Defined as the number of neonates diagnosed with neonatal jaundice requiring phototherapy during the postnatal hospital stay. Phototherapy requirement will be determined according to local neonatal clinical practice based on serum or transcutaneous bilirubin assessment.	From delivery until hospital discharge, assessed up to 20 weeks postpartum
Number of neonates with neonatal hypoglycemia	Neonatal hypoglycemia - glucose concentrations in neonatal blood <40 mg/dL (2.2 mmol/L) in a single laboratory measurement at least 3 hours after birth, in the first 24 hours of life	Assessed from delivery until 24 hours postpartum
Stillbirth	Pregnancy loss after 22 weeks	From week 22
Neonatal length of hospital stay	Duration of neonatal hospitalization, measured in days	From date of delivery until the date of hospital discharge, assessed up to 20 weeks
Length of stay in the neonatal intensive care unit (NICU)	Duration of NICU stay, measured in days	From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
Neonatal acidosis	Umbilical pH <7.15	At delivery
Apgar score	Apgar score <8	At delivery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Collaborators: Medtronic
• Investigators: Principal Investigator: Ewa Wender-Ozegowska, Prof. MD PhD, Poznan University of Medical Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; type 2 diabetes; insulin pump; Automated insulin delivery system
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 599_25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes