Pregnancy, Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, pregnancy, insulin pump, Automated insulin delivery system
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.
Detailed 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. 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.
Interventions
DEVICEAutomated insulin delivery system - Medtronic 780G
Use of automated insulin delivery system in pregnant patients with type 2 diabetes
Sponsors
Poznan University of Medical Sciences
Medtronic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single group longitudinal observational design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 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 | From enrollment to the delivery | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | Week 18 | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) |
| Time in tight range | Week 18 | 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 | 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 | Week 18 | Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L) |
| Time above tight range | Week 18 | Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L) |
| Time below range | Week 18 | Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L) |
| Mean sensor glycemia | Week 18 | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) |
| Coefficient of variation (%CV) | Week 18 | Metric of glycemic variability measured by the sensor (%) |
| Standard deviation (SD) | Week 18 | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) |
| HbA1C | Week 18 | Blood glycated hemoglobin measurement (% and mmol/mol) |
| Severe hypoglycemia episodes | From recruitment until delivery. | Number of episodes of self-reported severe hypoglycemia. |
| Gestational weight gain | From recruitment until delivery | Maternal gestational weight gain (kg) |
| Gestational weight gain from pre-pregnancy | From pre-pregnancy until delivery | Self-reported maternal gestational weight gain (kg) |
| Pregnancy hypertensive disorders | From recruitment until delivery | Preeclampsia, Eclampsia, Gestational hypertension |
| The mode of delivery | At delivery | Vaginal, c-section, spontaneous, induction of labor |
| Birth trauma | At delivery | IADPSG criteria |
| Gestational birth weight | At delivery | Neonatal birth weight in grams |
| Macrosomia | At delivery | Gestational birth weight \>4200g |
| Large-for-gestational-age (LGA) | At delivery | Neonatal birth weight \>90th percentile |
| Small-for-gestational-age (SGA) | At delivery | Neonatal birth weight \>10th percentile |
| Placental weight | At delivery | Measured in grams |
| Gestational age | At delivery | Timing of delivery |
| Preterm birth | At delivery | \<37 weeks |
| Number of neonates with respiratory distress syndrome | 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 | 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 | 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 | From week 22 | Pregnancy loss after 22 weeks |
| Neonatal length of hospital stay | 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) | 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 | At delivery | Umbilical pH \<7.15 |
| Apgar score | At delivery | Apgar score \<8 |
Countries
Poland
Contacts
CONTACTEwa Wender-Ozegowska, Prof. MD PhD
PRINCIPAL_INVESTIGATOREwa Wender-Ozegowska, Prof. MD PhD
Poznan University of Medical Sciences
Outcome results
None listed