Health TrialsbyHealthPanel

Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

ConditionsPregnancyType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPoznan University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Automated insulin delivery system - Medtronic 780G

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Type 2 diabetesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time in range

Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)

Time frame
From enrollment to the delivery
2

Mean sensor glycemia

Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)

Time frame
From enrollment to the delivery

Secondary outcomes

1

Time in range

Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)

Time frame
Week 18
2

Time in range

Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)

Time frame
Week 22
3

Time in range

Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)

Time frame
Week 26
4

Time in range

Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)

Time frame
Week 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poznan University of Medical Sciences

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: