NCT07602036

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
33mo left

Started May 2026

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Feb 2029

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

May 6, 2026

Last Update Submit

May 15, 2026

Conditions

PregnancyType 2 Diabetes

Keywords

type 2 diabetespregnancyinsulin pumpAutomated insulin delivery system

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (76)

  • Time in range

    Week 18

  • Time in range

    Week 22

  • Time in range

    Week 26

  • Time in range

    Week 30

  • Time in range

    Week 34

  • +71 more secondary outcomes

Study Arms (1)

Type 2 diabetes

EXPERIMENTAL

Pregnant patients with type 2 diabetes treated with automated insulin delivery system

Device: Automated insulin delivery system - Medtronic 780G

Interventions

Automated insulin delivery system - Medtronic 780GDEVICE

Use of automated insulin delivery system in pregnant patients with type 2 diabetes

Type 2 diabetes

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences

Poznan, Wielkopolska, 60-535, Poland

Location

Related Publications (2)

  • 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: 41807957BACKGROUND

  • 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: 41562177BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ewa Wender-Ozegowska, Prof. MD PhD

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewa Wender-Ozegowska, Prof. MD PhD

CONTACT

+48 (61) 841-93-02ewozegow@ump.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single group longitudinal observational design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 22, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)