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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes | Experimental | Pregnant patients with type 2 diabetes treated with automated insulin delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated insulin delivery system - Medtronic 780G | Device | Use of automated insulin delivery system in pregnant patients with type 2 diabetes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) | From enrollment to the delivery |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | From enrollment to the delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) | Week 18 |
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ewa Wender-Ozegowska, Prof. MD PhD | Contact | +48 (61) 841-93-02 | ewozegow@ump.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Ewa Wender-Ozegowska, Prof. MD PhD | Poznan University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences | Poznan | Wielkopolska | 60-535 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41807957 | Background | Gladych-Macioszek A, Mantaj U, Tobola-Wrobel K, Radzicka-Mularczyk S, Sibiak R, Adamczak L, Desoye G, Wender-Ozegowska E. Early gestational diabetes mellitus and type 2 diabetes: do they differ in perinatal outcome- a retrospective analysis. BMC Pregnancy Childbirth. 2026 Mar 11;26(1):423. doi: 10.1186/s12884-026-08927-3. | |
| 41562177 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single group longitudinal observational design
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| Week 22 |
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) | Week 26 |
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) | Week 30 |
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) | Week 34 |
| Time in range | Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L) | Week 37 |
| Time in tight range | Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L) | Week 18 |
| Time in tight range | Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L) | Week 22 |
| Time in tight range | Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L) | Week 26 |
| Time in tight range | Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L) | Week 30 |
| Time in tight range | Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L) | Week 34 |
| Time in tight range | Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L) | 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) | From the recruitment to delivery |
| Time above range | Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L) | Week 18 |
| Time above range | Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L) | Week 22 |
| Time above range | Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L) | Week 26 |
| Time above range | Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L) | Week 30 |
| Time above range | Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L) | Week 34 |
| Time above range | Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L) | Week 37 |
| Time above tight range | Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L) | Week 18 |
| Time above tight range | Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L) | Week 22 |
| Time above tight range | Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L) | Week 26 |
| Time above tight range | Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L) | Week 30 |
| Time above tight range | Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L) | Week 34 |
| Time above tight range | Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L) | Week 37 |
| Time below range | Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L) | Week 18 |
| Time below range | Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L) | Week 22 |
| Time below range | Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L) | Week 26 |
| Time below range | Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L) | Week 30 |
| Time below range | Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L) | Week 34 |
| Time below range | Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L) | Week 37 |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | Week 18 |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | Week 22 |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | Week 26 |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | Week 30 |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | Week 34 |
| Mean sensor glycemia | Average value of glucose concentration measured by the sensor (mg/dL and mmol/L) | Week 37 |
| Coefficient of variation (%CV) | Metric of glycemic variability measured by the sensor (%) | Week 18 |
| Coefficient of variation (%CV) | Metric of glycemic variability measured by the sensor (%) | Week 22 |
| Coefficient of variation (%CV) | Metric of glycemic variability measured by the sensor (%) | Week 26 |
| Coefficient of variation (%CV) | Metric of glycemic variability measured by the sensor (%) | Week 30 |
| Coefficient of variation (%CV) | Metric of glycemic variability measured by the sensor (%) | Week 34 |
| Coefficient of variation (%CV) | Metric of glycemic variability measured by the sensor (%) | Week 37 |
| Standard deviation (SD) | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) | Week 18 |
| Standard deviation (SD) | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) | Week 22 |
| Standard deviation (SD) | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) | Week 26 |
| Standard deviation (SD) | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) | Week 30 |
| Standard deviation (SD) | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) | Week 34 |
| Standard deviation (SD) | Metric of glycemic variability measured by the sensor (mg/dL and mmol/L) | Week 37 |
| HbA1C | Blood glycated hemoglobin measurement (% and mmol/mol) | Week 18 |
| HbA1C | Blood glycated hemoglobin measurement (% and mmol/mol) | Week 22 |
| HbA1C | Blood glycated hemoglobin measurement (% and mmol/mol) | Week 26 |
| HbA1C | Blood glycated hemoglobin measurement (% and mmol/mol) | Week 30 |
| HbA1C | Blood glycated hemoglobin measurement (% and mmol/mol) | Week 34 |
| HbA1C | Blood glycated hemoglobin measurement (% and mmol/mol) | Week 37 |
| Severe hypoglycemia episodes | Number of episodes of self-reported severe hypoglycemia. | From recruitment until delivery. |
| Gestational weight gain | Maternal gestational weight gain (kg) | From recruitment until delivery |
| Gestational weight gain from pre-pregnancy | Self-reported maternal gestational weight gain (kg) | From pre-pregnancy until delivery |
| Pregnancy hypertensive disorders | Preeclampsia, Eclampsia, Gestational hypertension | From recruitment until delivery |
| The mode of delivery | Vaginal, c-section, spontaneous, induction of labor | At delivery |
| Birth trauma | IADPSG criteria | At delivery |
| Gestational birth weight | Neonatal birth weight in grams | At delivery |
| Macrosomia | Gestational birth weight >4200g | At delivery |
| Large-for-gestational-age (LGA) | Neonatal birth weight >90th percentile | At delivery |
| Small-for-gestational-age (SGA) | Neonatal birth weight >10th percentile | At delivery |
| Placental weight | Measured in grams | At delivery |
| Gestational age | Timing of delivery | At delivery |
| Preterm birth | <37 weeks | 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. | 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. | 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 | Assessed from delivery until 24 hours postpartum |
| Stillbirth | Pregnancy loss after 22 weeks | From week 22 |
| Neonatal length of hospital stay | Duration of neonatal hospitalization, measured in days | 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 | From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks |
| Neonatal acidosis | Umbilical pH <7.15 | At delivery |
| Apgar score | Apgar score <8 | At delivery |
| Sibiak R, Iciek R, Gastolek K, Chudzynska E, Meek C, Wender-Ozegowska E. Ten-year national trends in the prevalence and outcomes of gestational diabetes mellitus in Poland: a population-based study. Pol Arch Intern Med. 2026 Feb 26;136(2):17202. doi: 10.20452/pamw.17202. Epub 2026 Jan 19. |
| D004700 | Endocrine System Diseases |