Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

N/ANot Yet RecruitingNCT07602036

Poznan University of Medical Sciences20 enrolled

Overview

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.

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

Allocation

Conditions

Pregnancy Type 2 Diabetes

Interventions

Automated insulin delivery system - Medtronic 780GDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Poznan, Wielkopolska, Poland

Outcomes

Primary Outcomes

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

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

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

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

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

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

Time in range

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

Time frame: Week 34

Time in range

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

Time frame: Week 37

Time in tight range

Central Contacts

Ewa Wender-Ozegowska, Prof. MD PhD

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)

Time in tight range

Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)

Time frame: Week 22

Time in tight range

Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)

Time frame: Week 26

Time in tight range

Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)

Time frame: Week 30

Time in tight range

Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)

Time frame: Week 34

Time in tight range

Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)

Time frame: 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)

Time frame: From the recruitment to delivery

Time above range

Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)

Time frame: Week 18

Time above range

Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)

Time frame: Week 22

Time above range

Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)

Time frame: Week 26

Time above range

Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)

Time frame: Week 30

Time above range

Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)

Time frame: Week 34

Time above range

Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)

Time frame: Week 37

Time above tight range

Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)

Time frame: Week 18

Time above tight range

Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)

Time frame: Week 22

Time above tight range

Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)

Time frame: Week 26

Time above tight range

Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)

Time frame: Week 30

Time above tight range

Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)

Time frame: Week 34

Time above tight range

Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)

Time frame: Week 37

Time below range

Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)

Time frame: Week 18

Time below range

Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)

Time frame: Week 22

Time below range

Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)

Time frame: Week 26

Time below range

Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)

Time frame: Week 30

Time below range

Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)

Time frame: Week 34

Time below range

Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)

Time frame: Week 37

Mean sensor glycemia

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

Time frame: Week 18

Mean sensor glycemia

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

Time frame: Week 22

Mean sensor glycemia

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

Time frame: Week 26

Mean sensor glycemia

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

Time frame: Week 30

Mean sensor glycemia

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

Time frame: Week 34

Mean sensor glycemia

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

Time frame: Week 37

Coefficient of variation (%CV)

Metric of glycemic variability measured by the sensor (%)

Time frame: Week 18

Coefficient of variation (%CV)

Metric of glycemic variability measured by the sensor (%)

Time frame: Week 22

Coefficient of variation (%CV)

Metric of glycemic variability measured by the sensor (%)

Time frame: Week 26

Coefficient of variation (%CV)

Metric of glycemic variability measured by the sensor (%)

Time frame: Week 30

Coefficient of variation (%CV)

Metric of glycemic variability measured by the sensor (%)

Time frame: Week 34

Coefficient of variation (%CV)

Metric of glycemic variability measured by the sensor (%)

Time frame: Week 37

Standard deviation (SD)

Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)

Time frame: Week 18

Standard deviation (SD)

Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)

Time frame: Week 22

Standard deviation (SD)

Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)

Time frame: Week 26

Standard deviation (SD)

Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)

Time frame: Week 30

Standard deviation (SD)

Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)

Time frame: Week 34

Standard deviation (SD)

Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)

Time frame: Week 37

HbA1C

Blood glycated hemoglobin measurement (% and mmol/mol)

Time frame: Week 18

HbA1C

Blood glycated hemoglobin measurement (% and mmol/mol)

Time frame: Week 22

HbA1C

Blood glycated hemoglobin measurement (% and mmol/mol)

Time frame: Week 26

HbA1C

Blood glycated hemoglobin measurement (% and mmol/mol)

Time frame: Week 30

HbA1C

Blood glycated hemoglobin measurement (% and mmol/mol)

Time frame: Week 34

HbA1C

Blood glycated hemoglobin measurement (% and mmol/mol)

Time frame: Week 37

Severe hypoglycemia episodes

Number of episodes of self-reported severe hypoglycemia.

Time frame: From recruitment until delivery.

Gestational weight gain

Maternal gestational weight gain (kg)

Time frame: From recruitment until delivery

Gestational weight gain from pre-pregnancy

Self-reported maternal gestational weight gain (kg)

Time frame: From pre-pregnancy until delivery

Pregnancy hypertensive disorders

Preeclampsia, Eclampsia, Gestational hypertension

Time frame: From recruitment until delivery

The mode of delivery

Vaginal, c-section, spontaneous, induction of labor

Time frame: At delivery

Birth trauma

IADPSG criteria

Time frame: At delivery

Gestational birth weight

Neonatal birth weight in grams

Time frame: At delivery

Macrosomia

Gestational birth weight \>4200g

Time frame: At delivery

Large-for-gestational-age (LGA)

Neonatal birth weight \>90th percentile

Time frame: At delivery

Small-for-gestational-age (SGA)

Neonatal birth weight \>10th percentile

Time frame: At delivery

Placental weight

Measured in grams

Time frame: At delivery

Gestational age

Timing of delivery

Time frame: At delivery

Preterm birth

\<37 weeks

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Assessed from delivery until 24 hours postpartum

Stillbirth

Pregnancy loss after 22 weeks

Time frame: From week 22

Neonatal length of hospital stay

Duration of neonatal hospitalization, measured in days

Time frame: 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

Time frame: From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks

Neonatal acidosis

Umbilical pH \<7.15

Time frame: At delivery

Apgar score

Apgar score \<8

Time frame: At delivery