Type 2 Diabetes and Pregnancy a Single-arm Interventional Study
Pregnancy · Type 2 Diabetes
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 45 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 20 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Type 2 diabetes
Pregnant patients with type 2 diabetes treated with automated insulin delivery system
Device: Automated insulin delivery system - Medtronic 780G
Automated insulin delivery system - Medtronic 780G DEVICE
Use of automated insulin delivery system in pregnant patients with type 2 diabetes
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Time in range
Time frame: From enrollment to the delivery
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Mean sensor glycemia
Time frame: From enrollment to the delivery
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Secondary measures
Time in range
Time frame: Week 18
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Time frame: Week 22
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Time frame: Week 26
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Time frame: Week 30
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Time frame: Week 34
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Time frame: Week 37
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in tight range
Time frame: Week 18
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Time frame: Week 22
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Time frame: Week 26
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Time frame: Week 30
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Time frame: Week 34
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Time frame: Week 37
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Change in the time in range values
Time frame: From the recruitment to delivery
Change in percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time above range
Time frame: Week 18
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Time frame: Week 22
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Time frame: Week 26
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Time frame: Week 30
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Time frame: Week 34
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Time frame: Week 37
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above tight range
Time frame: Week 18
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Time frame: Week 22
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Time frame: Week 26
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Time frame: Week 30
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Time frame: Week 34
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Time frame: Week 37
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time below range
Time frame: Week 18
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Time frame: Week 22
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Time frame: Week 26
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Time frame: Week 30
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Time frame: Week 34
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Time frame: Week 37
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Mean sensor glycemia
Time frame: Week 18
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Time frame: Week 22
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Time frame: Week 26
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Time frame: Week 30
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Time frame: Week 34
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Time frame: Week 37
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Coefficient of variation (%CV)
Time frame: Week 18
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Time frame: Week 22
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Time frame: Week 26
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Time frame: Week 30
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Time frame: Week 34
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Time frame: Week 37
Metric of glycemic variability measured by the sensor (%)
Standard deviation (SD)
Time frame: Week 18
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Time frame: Week 22
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Time frame: Week 26
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Time frame: Week 30
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Time frame: Week 34
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Time frame: Week 37
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
HbA1C
Time frame: Week 18
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Time frame: Week 22
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Time frame: Week 26
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Time frame: Week 30
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Time frame: Week 34
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Time frame: Week 37
Blood glycated hemoglobin measurement (% and mmol/mol)
Severe hypoglycemia episodes
Time frame: From recruitment until delivery.
Number of episodes of self-reported severe hypoglycemia.
Gestational weight gain
Time frame: From recruitment until delivery
Maternal gestational weight gain (kg)
Gestational weight gain from pre-pregnancy
Time frame: From pre-pregnancy until delivery
Self-reported maternal gestational weight gain (kg)
Pregnancy hypertensive disorders
Time frame: From recruitment until delivery
Preeclampsia, Eclampsia, Gestational hypertension
The mode of delivery
Time frame: At delivery
Vaginal, c-section, spontaneous, induction of labor
Birth trauma
Time frame: At delivery
IADPSG criteria
Gestational birth weight
Time frame: At delivery
Neonatal birth weight in grams
Macrosomia
Time frame: At delivery
Gestational birth weight \>4200g
Large-for-gestational-age (LGA)
Time frame: At delivery
Neonatal birth weight \>90th percentile
Small-for-gestational-age (SGA)
Time frame: At delivery
Neonatal birth weight \<10th percentile
Placental weight
Time frame: At delivery
Measured in grams
Gestational age
Time frame: At delivery
Timing of delivery
Preterm birth
Time frame: At delivery
\<37 weeks
Number of neonates with respiratory distress syndrome
Time frame: From delivery until hospital discharge, assessed up to 20 weeks postpartum
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.
Number of neonates with jaundice requiring phototherapy
Time frame: From delivery until hospital discharge, assessed up to 20 weeks postpartum
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.
Number of neonates with neonatal hypoglycemia
Time frame: Assessed from delivery until 24 hours postpartum
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
Stillbirth
Time frame: From week 22
Pregnancy loss after 22 weeks
Neonatal length of hospital stay
Time frame: From date of delivery until the date of hospital discharge, assessed up to 20 weeks
Duration of neonatal hospitalization, measured in days
Length of stay in the neonatal intensive care unit (NICU)
Time frame: From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
Duration of NICU stay, measured in days
Neonatal acidosis
Time frame: At delivery
Umbilical pH \<7.15
Apgar score
Time frame: At delivery
Apgar score \<8
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical SciencesPoznan, Wielkopolska, PolandRecruiting
Study team and timeline
- Lead sponsor
- Poznan University of Medical Sciences
- Study start
- May 8, 2026 Actual
- Primary completion
- 2028-10 Estimated
- Study completion
- 2029-02 Estimated
- First posted
- May 22, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Type 2 Diabetes and Pregnancy a Single-arm Interventional Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026