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PregnancypUMPreg2NCT07602036

Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

A study testing Automated insulin delivery system - Medtronic 780G in people with Pregnancy and Type 2 Diabetes, run by Poznan University of Medical Sciences at 1 site in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pregnancy, Type 2 Diabetes
What is being tested?
Automated insulin delivery system - Medtronic 780G
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePoland
Study dates
1 May 2026to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ewa Wender-Ozegowska, Prof. MD PhD contact

+48 (61) 841-93-02

ewozegow@ump.edu.pl

Poland1 site
  • Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences

    Poznan, Wielkopolska, 60-535

    Ewa Wender-Ozegowska, Prof. MD PhD, +48 (61) 841-93-02, ewozegow@ump.edu.pl

    Ewa Wender-Ozegowska, Prof. MD PhD

Other trials in Poland

About this 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.

Read the 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.

Being tested
Automated insulin delivery system - Medtronic 780G
Keywords
type 2 diabetes, pregnancy, insulin pump, Automated insulin delivery system
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated insulin delivery system - Medtronic 780GDevice

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

Study groups in NCT07602036
Study groupRoleWhat they receive
Type 2 diabetesExperimentalPregnant patients with type 2 diabetes treated with automated insulin delivery system
Receives: Device: Automated insulin delivery system - Medtronic 780G

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in range

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

    Measured: From enrollment to the delivery

  2. Mean sensor glycemia

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

    Measured: From enrollment to the delivery

Secondary outcomes (76)
  1. Time in range

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

    Measured: Week 18

  2. Time in range

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

    Measured: Week 22

  3. Time in range

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

    Measured: Week 26

  4. Time in range

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

    Measured: Week 30

  5. Time in range

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

    Measured: Week 34

  6. Time in range

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

    Measured: Week 37

  7. Time in tight range

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

    Measured: Week 18

  8. Time in tight range

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

    Measured: Week 22

  9. Time in tight range

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

    Measured: Week 26

  10. Time in tight range

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

    Measured: Week 30

  11. Time in tight range

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

    Measured: Week 34

  12. Time in tight range

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

    Measured: Week 37

  13. 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)

    Measured: From the recruitment to delivery

  14. Time above range

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

    Measured: Week 18

  15. Time above range

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

    Measured: Week 22

  16. Time above range

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

    Measured: Week 26

  17. Time above range

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

    Measured: Week 30

  18. Time above range

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

    Measured: Week 34

  19. Time above range

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

    Measured: Week 37

  20. Time above tight range

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

    Measured: Week 18

  21. Time above tight range

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

    Measured: Week 22

  22. Time above tight range

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

    Measured: Week 26

  23. Time above tight range

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

    Measured: Week 30

  24. Time above tight range

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

    Measured: Week 34

  25. Time above tight range

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

    Measured: Week 37

  26. Time below range

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

    Measured: Week 18

  27. Time below range

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

    Measured: Week 22

  28. Time below range

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

    Measured: Week 26

  29. Time below range

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

    Measured: Week 30

  30. Time below range

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

    Measured: Week 34

  31. Time below range

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

    Measured: Week 37

  32. Mean sensor glycemia

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

    Measured: Week 18

  33. Mean sensor glycemia

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

    Measured: Week 22

  34. Mean sensor glycemia

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

    Measured: Week 26

  35. Mean sensor glycemia

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

    Measured: Week 30

  36. Mean sensor glycemia

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

    Measured: Week 34

  37. Mean sensor glycemia

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

    Measured: Week 37

  38. Coefficient of variation (%CV)

    Metric of glycemic variability measured by the sensor (%)

    Measured: Week 18

  39. Coefficient of variation (%CV)

    Metric of glycemic variability measured by the sensor (%)

    Measured: Week 22

  40. Coefficient of variation (%CV)

    Metric of glycemic variability measured by the sensor (%)

    Measured: Week 26

  41. Coefficient of variation (%CV)

    Metric of glycemic variability measured by the sensor (%)

    Measured: Week 30

  42. Coefficient of variation (%CV)

    Metric of glycemic variability measured by the sensor (%)

    Measured: Week 34

  43. Coefficient of variation (%CV)

    Metric of glycemic variability measured by the sensor (%)

    Measured: Week 37

  44. Standard deviation (SD)

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

    Measured: Week 18

  45. Standard deviation (SD)

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

    Measured: Week 22

  46. Standard deviation (SD)

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

    Measured: Week 26

  47. Standard deviation (SD)

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

    Measured: Week 30

  48. Standard deviation (SD)

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

    Measured: Week 34

  49. Standard deviation (SD)

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

    Measured: Week 37

  50. HbA1C

    Blood glycated hemoglobin measurement (% and mmol/mol)

    Measured: Week 18

  51. HbA1C

    Blood glycated hemoglobin measurement (% and mmol/mol)

    Measured: Week 22

  52. HbA1C

    Blood glycated hemoglobin measurement (% and mmol/mol)

    Measured: Week 26

  53. HbA1C

    Blood glycated hemoglobin measurement (% and mmol/mol)

    Measured: Week 30

  54. HbA1C

    Blood glycated hemoglobin measurement (% and mmol/mol)

    Measured: Week 34

  55. HbA1C

    Blood glycated hemoglobin measurement (% and mmol/mol)

    Measured: Week 37

  56. Severe hypoglycemia episodes

    Number of episodes of self-reported severe hypoglycemia.

    Measured: From recruitment until delivery.

  57. Gestational weight gain

    Maternal gestational weight gain (kg)

    Measured: From recruitment until delivery

  58. Gestational weight gain from pre-pregnancy

    Self-reported maternal gestational weight gain (kg)

    Measured: From pre-pregnancy until delivery

  59. Pregnancy hypertensive disorders

    Preeclampsia, Eclampsia, Gestational hypertension

    Measured: From recruitment until delivery

  60. The mode of delivery

    Vaginal, c-section, spontaneous, induction of labor

    Measured: At delivery

  61. Birth trauma

    IADPSG criteria

    Measured: At delivery

  62. Gestational birth weight

    Neonatal birth weight in grams

    Measured: At delivery

  63. Macrosomia

    Gestational birth weight >4200g

    Measured: At delivery

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

    Neonatal birth weight >90th percentile

    Measured: At delivery

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

    Neonatal birth weight >10th percentile

    Measured: At delivery

  66. Placental weight

    Measured in grams

    Measured: At delivery

  67. Gestational age

    Timing of delivery

    Measured: At delivery

  68. Preterm birth

    <37 weeks

    Measured: At delivery

  69. 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.

    Measured: From delivery until hospital discharge, assessed up to 20 weeks postpartum

  70. 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.

    Measured: From delivery until hospital discharge, assessed up to 20 weeks postpartum

  71. 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

    Measured: Assessed from delivery until 24 hours postpartum

  72. Stillbirth

    Pregnancy loss after 22 weeks

    Measured: From week 22

  73. Neonatal length of hospital stay

    Duration of neonatal hospitalization, measured in days

    Measured: From date of delivery until the date of hospital discharge, assessed up to 20 weeks

  74. Length of stay in the neonatal intensive care unit (NICU)

    Duration of NICU stay, measured in days

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

  75. Neonatal acidosis

    Umbilical pH <7.15

    Measured: At delivery

  76. Apgar score

    Apgar score <8

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Single group longitudinal observational design
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07602036
Sponsor's protocol ID
599_25
Acronym
pUMPreg2
Status last verified
May 2026
First submitted
6 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 41807957
  • 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.

    PubMed 41562177

Questions about this trial

What is this clinical trial studying?

A study testing Automated insulin delivery system - Medtronic 780G in people with Pregnancy and Type 2 Diabetes, run by Poznan University of Medical Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ewa Wender-Ozegowska, Prof. MD PhD (+48 (61) 841-93-02, ewozegow@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in range (time frame: From enrollment to the delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07602036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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