Type 2 Diabetes and Pregnancy a Single-arm Interventional Study (pUMPreg2)
15 mei 2026 bijgewerkt door: Poznan University of Medical Sciences
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
20
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ewa Wender-Ozegowska, Prof. MD PhD
- Telefoonnummer: +48 (61) 841-93-02
- E-mail: ewozegow@ump.edu.pl
Studie Locaties
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polen, 60-535
- Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
-
Contact:
- Ewa Wender-Ozegowska, Prof. MD PhD
- Telefoonnummer: +48 (61) 841-93-02
- E-mail: ewozegow@ump.edu.pl
-
Hoofdonderzoeker:
- Ewa Wender-Ozegowska, Prof. MD PhD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Type 2 diabetes
Pregnant patients with type 2 diabetes treated with automated insulin delivery system
|
Use of automated insulin delivery system in pregnant patients with type 2 diabetes
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time in range
Tijdsspanne: From enrollment to the delivery
|
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
Tijdsspanne: From enrollment to the delivery
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
From enrollment to the delivery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time in range
Tijdsspanne: Week 18
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 18
|
|
Time in range
Tijdsspanne: Week 22
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 22
|
|
Time in range
Tijdsspanne: Week 26
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 26
|
|
Time in range
Tijdsspanne: Week 30
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 30
|
|
Time in range
Tijdsspanne: Week 34
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 34
|
|
Time in range
Tijdsspanne: Week 37
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 37
|
|
Time in tight range
Tijdsspanne: Week 18
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 18
|
|
Time in tight range
Tijdsspanne: Week 22
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 22
|
|
Time in tight range
Tijdsspanne: Week 26
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 26
|
|
Time in tight range
Tijdsspanne: Week 30
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 30
|
|
Time in tight range
Tijdsspanne: Week 34
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 34
|
|
Time in tight range
Tijdsspanne: Week 37
|
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
Tijdsspanne: 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)
|
From the recruitment to delivery
|
|
Time above range
Tijdsspanne: Week 18
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 18
|
|
Time above range
Tijdsspanne: Week 22
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 22
|
|
Time above range
Tijdsspanne: Week 26
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 26
|
|
Time above range
Tijdsspanne: Week 30
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 30
|
|
Time above range
Tijdsspanne: Week 34
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 34
|
|
Time above range
Tijdsspanne: Week 37
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 37
|
|
Time above tight range
Tijdsspanne: Week 18
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 18
|
|
Time above tight range
Tijdsspanne: Week 22
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 22
|
|
Time above tight range
Tijdsspanne: Week 26
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 26
|
|
Time above tight range
Tijdsspanne: Week 30
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 30
|
|
Time above tight range
Tijdsspanne: Week 34
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 34
|
|
Time above tight range
Tijdsspanne: Week 37
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 37
|
|
Time below range
Tijdsspanne: Week 18
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 18
|
|
Time below range
Tijdsspanne: Week 22
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 22
|
|
Time below range
Tijdsspanne: Week 26
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 26
|
|
Time below range
Tijdsspanne: Week 30
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 30
|
|
Time below range
Tijdsspanne: Week 34
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 34
|
|
Time below range
Tijdsspanne: Week 37
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 37
|
|
Mean sensor glycemia
Tijdsspanne: Week 18
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Mean sensor glycemia
Tijdsspanne: Week 22
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Mean sensor glycemia
Tijdsspanne: Week 26
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Mean sensor glycemia
Tijdsspanne: Week 30
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Mean sensor glycemia
Tijdsspanne: Week 34
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Mean sensor glycemia
Tijdsspanne: Week 37
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
Coefficient of variation (%CV)
Tijdsspanne: Week 18
|
Metric of glycemic variability measured by the sensor (%)
|
Week 18
|
|
Coefficient of variation (%CV)
Tijdsspanne: Week 22
|
Metric of glycemic variability measured by the sensor (%)
|
Week 22
|
|
Coefficient of variation (%CV)
Tijdsspanne: Week 26
|
Metric of glycemic variability measured by the sensor (%)
|
Week 26
|
|
Coefficient of variation (%CV)
Tijdsspanne: Week 30
|
Metric of glycemic variability measured by the sensor (%)
|
Week 30
|
|
Coefficient of variation (%CV)
Tijdsspanne: Week 34
|
Metric of glycemic variability measured by the sensor (%)
|
Week 34
|
|
Coefficient of variation (%CV)
Tijdsspanne: Week 37
|
Metric of glycemic variability measured by the sensor (%)
|
Week 37
|
|
Standard deviation (SD)
Tijdsspanne: Week 18
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Standard deviation (SD)
Tijdsspanne: Week 22
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Standard deviation (SD)
Tijdsspanne: Week 26
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Standard deviation (SD)
Tijdsspanne: Week 30
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Standard deviation (SD)
Tijdsspanne: Week 34
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Standard deviation (SD)
Tijdsspanne: Week 37
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
HbA1C
Tijdsspanne: Week 18
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 18
|
|
HbA1C
Tijdsspanne: Week 22
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 22
|
|
HbA1C
Tijdsspanne: Week 26
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 26
|
|
HbA1C
Tijdsspanne: Week 30
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 30
|
|
HbA1C
Tijdsspanne: Week 34
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 34
|
|
HbA1C
Tijdsspanne: Week 37
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 37
|
|
Severe hypoglycemia episodes
Tijdsspanne: From recruitment until delivery.
|
Number of episodes of self-reported severe hypoglycemia.
|
From recruitment until delivery.
|
|
Gestational weight gain
Tijdsspanne: From recruitment until delivery
|
Maternal gestational weight gain (kg)
|
From recruitment until delivery
|
|
Gestational weight gain from pre-pregnancy
Tijdsspanne: From pre-pregnancy until delivery
|
Self-reported maternal gestational weight gain (kg)
|
From pre-pregnancy until delivery
|
|
Pregnancy hypertensive disorders
Tijdsspanne: From recruitment until delivery
|
Preeclampsia, Eclampsia, Gestational hypertension
|
From recruitment until delivery
|
|
The mode of delivery
Tijdsspanne: At delivery
|
Vaginal, c-section, spontaneous, induction of labor
|
At delivery
|
|
Birth trauma
Tijdsspanne: At delivery
|
IADPSG criteria
|
At delivery
|
|
Gestational birth weight
Tijdsspanne: At delivery
|
Neonatal birth weight in grams
|
At delivery
|
|
Macrosomia
Tijdsspanne: At delivery
|
Gestational birth weight >4200g
|
At delivery
|
|
Large-for-gestational-age (LGA)
Tijdsspanne: At delivery
|
Neonatal birth weight >90th percentile
|
At delivery
|
|
Small-for-gestational-age (SGA)
Tijdsspanne: At delivery
|
Neonatal birth weight >10th percentile
|
At delivery
|
|
Placental weight
Tijdsspanne: At delivery
|
Measured in grams
|
At delivery
|
|
Gestational age
Tijdsspanne: At delivery
|
Timing of delivery
|
At delivery
|
|
Preterm birth
Tijdsspanne: At delivery
|
<37 weeks
|
At delivery
|
|
Number of neonates with respiratory distress syndrome
Tijdsspanne: 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.
|
From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
|
Number of neonates with jaundice requiring phototherapy
Tijdsspanne: 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.
|
From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
|
Number of neonates with neonatal hypoglycemia
Tijdsspanne: 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
|
Assessed from delivery until 24 hours postpartum
|
|
Stillbirth
Tijdsspanne: From week 22
|
Pregnancy loss after 22 weeks
|
From week 22
|
|
Neonatal length of hospital stay
Tijdsspanne: From date of delivery until the date of hospital discharge, assessed up to 20 weeks
|
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)
Tijdsspanne: From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
|
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
Tijdsspanne: At delivery
|
Umbilical pH <7.15
|
At delivery
|
|
Apgar score
Tijdsspanne: At delivery
|
Apgar score <8
|
At delivery
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ewa Wender-Ozegowska, Prof. MD PhD, Poznan University of Medical Sciences
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 mei 2026
Primaire voltooiing (Geschat)
1 oktober 2028
Studie voltooiing (Geschat)
1 februari 2029
Studieregistratiedata
Eerst ingediend
6 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
15 mei 2026
Eerst geplaatst (Werkelijk)
22 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
15 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 599_25
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .