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NCT Number: NCT07602036

Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

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.

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Poznan, Wielkopolska, 60-535, Poland

Location contact

Ewa Wender-Ozegowska, Prof. MD PhD

CONTACT

[email protected]

+48 (61) 841-93-02

Ewa Wender-Ozegowska, Prof. MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • HbA1c at baseline 5.0-10%
  • A viable pregnancy at the recruitment
  • Willingness to continue the treatment until delivery in the clinic

Exclusion criteria

  • 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

Treatment and study plan

Automated insulin delivery system - Medtronic 780G

Device

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

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. Time above range

    Time frame: Week 18

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

  15. Time above range

    Time frame: Week 22

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

  16. Time above range

    Time frame: Week 26

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

  17. Time above range

    Time frame: Week 30

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

  18. Time above range

    Time frame: Week 34

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

  19. Time above range

    Time frame: Week 37

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

  20. Time above tight range

    Time frame: Week 18

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

  21. Time above tight range

    Time frame: Week 22

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

  22. Time above tight range

    Time frame: Week 26

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

  23. Time above tight range

    Time frame: Week 30

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

  24. Time above tight range

    Time frame: Week 34

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

  25. Time above tight range

    Time frame: Week 37

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

  26. Time below range

    Time frame: Week 18

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

  27. Time below range

    Time frame: Week 22

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

  28. Time below range

    Time frame: Week 26

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

  29. Time below range

    Time frame: Week 30

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

  30. Time below range

    Time frame: Week 34

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

  31. Time below range

    Time frame: Week 37

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

  32. Mean sensor glycemia

    Time frame: Week 18

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

  33. Mean sensor glycemia

    Time frame: Week 22

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

  34. Mean sensor glycemia

    Time frame: Week 26

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

  35. Mean sensor glycemia

    Time frame: Week 30

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

  36. Mean sensor glycemia

    Time frame: Week 34

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

  37. Mean sensor glycemia

    Time frame: Week 37

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

  38. Coefficient of variation (%CV)

    Time frame: Week 18

    Metric of glycemic variability measured by the sensor (%)

  39. Coefficient of variation (%CV)

    Time frame: Week 22

    Metric of glycemic variability measured by the sensor (%)

  40. Coefficient of variation (%CV)

    Time frame: Week 26

    Metric of glycemic variability measured by the sensor (%)

  41. Coefficient of variation (%CV)

    Time frame: Week 30

    Metric of glycemic variability measured by the sensor (%)

  42. Coefficient of variation (%CV)

    Time frame: Week 34

    Metric of glycemic variability measured by the sensor (%)

  43. Coefficient of variation (%CV)

    Time frame: Week 37

    Metric of glycemic variability measured by the sensor (%)

  44. Standard deviation (SD)

    Time frame: Week 18

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

  45. Standard deviation (SD)

    Time frame: Week 22

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

  46. Standard deviation (SD)

    Time frame: Week 26

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

  47. Standard deviation (SD)

    Time frame: Week 30

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

  48. Standard deviation (SD)

    Time frame: Week 34

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

  49. Standard deviation (SD)

    Time frame: Week 37

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

  50. HbA1C

    Time frame: Week 18

    Blood glycated hemoglobin measurement (% and mmol/mol)

  51. HbA1C

    Time frame: Week 22

    Blood glycated hemoglobin measurement (% and mmol/mol)

  52. HbA1C

    Time frame: Week 26

    Blood glycated hemoglobin measurement (% and mmol/mol)

  53. HbA1C

    Time frame: Week 30

    Blood glycated hemoglobin measurement (% and mmol/mol)

  54. HbA1C

    Time frame: Week 34

    Blood glycated hemoglobin measurement (% and mmol/mol)

  55. HbA1C

    Time frame: Week 37

    Blood glycated hemoglobin measurement (% and mmol/mol)

  56. Severe hypoglycemia episodes

    Time frame: From recruitment until delivery.

    Number of episodes of self-reported severe hypoglycemia.

  57. Gestational weight gain

    Time frame: From recruitment until delivery

    Maternal gestational weight gain (kg)

  58. Gestational weight gain from pre-pregnancy

    Time frame: From pre-pregnancy until delivery

    Self-reported maternal gestational weight gain (kg)

  59. Pregnancy hypertensive disorders

    Time frame: From recruitment until delivery

    Preeclampsia, Eclampsia, Gestational hypertension

  60. The mode of delivery

    Time frame: At delivery

    Vaginal, c-section, spontaneous, induction of labor

  61. Birth trauma

    Time frame: At delivery

    IADPSG criteria

  62. Gestational birth weight

    Time frame: At delivery

    Neonatal birth weight in grams

  63. Macrosomia

    Time frame: At delivery

    Gestational birth weight >4200g

  64. Large-for-gestational-age (LGA)

    Time frame: At delivery

    Neonatal birth weight >90th percentile

  65. Small-for-gestational-age (SGA)

    Time frame: At delivery

    Neonatal birth weight >10th percentile

  66. Placental weight

    Time frame: At delivery

    Measured in grams

  67. Gestational age

    Time frame: At delivery

    Timing of delivery

  68. Preterm birth

    Time frame: At delivery

    <37 weeks

  69. 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.

  70. 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.

  71. 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

  72. Stillbirth

    Time frame: From week 22

    Pregnancy loss after 22 weeks

  73. 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

  74. 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

  75. Neonatal acidosis

    Time frame: At delivery

    Umbilical pH <7.15

  76. Apgar score

    Time frame: At delivery

    Apgar score <8

Study contacts

Contact information is provided by the study sponsor or research team.

Ewa Wender-Ozegowska, Prof. MD PhD

CONTACT

[email protected]

+48 (61) 841-93-02

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • Medtronic

Registry information

Acronym: pUMPreg2

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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