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Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

NCT07602036 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Automated insulin delivery system - Medtronic 780G

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ewa Wender-Ozegowska, Prof. MD PhD · Poznan University of Medical Sciences

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-10-31
Completion
2029-02-28
FDA Device
Yes

Countries

  • Poland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07602036 on ClinicalTrials.gov