Type 2 Diabetes and Pregnancy a Single-arm Interventional Study (pUMPreg2)
15. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ewa Wender-Ozegowska, Prof. MD PhD
- Telefonnummer: +48 (61) 841-93-02
- E-mail: ewozegow@ump.edu.pl
Studiesteder
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polen, 60-535
- Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
-
Kontakt:
- Ewa Wender-Ozegowska, Prof. MD PhD
- Telefonnummer: +48 (61) 841-93-02
- E-mail: ewozegow@ump.edu.pl
-
Ledende efterforsker:
- Ewa Wender-Ozegowska, Prof. MD PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time in range
Tidsramme: 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
Tidsramme: From enrollment to the delivery
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
From enrollment to the delivery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time in range
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 18
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 18
|
|
Time above range
Tidsramme: Week 22
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 22
|
|
Time above range
Tidsramme: Week 26
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 26
|
|
Time above range
Tidsramme: Week 30
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 30
|
|
Time above range
Tidsramme: Week 34
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 34
|
|
Time above range
Tidsramme: Week 37
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 37
|
|
Time above tight range
Tidsramme: Week 18
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 18
|
|
Time above tight range
Tidsramme: Week 22
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 22
|
|
Time above tight range
Tidsramme: Week 26
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 26
|
|
Time above tight range
Tidsramme: Week 30
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 30
|
|
Time above tight range
Tidsramme: Week 34
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 34
|
|
Time above tight range
Tidsramme: Week 37
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 37
|
|
Time below range
Tidsramme: Week 18
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 18
|
|
Time below range
Tidsramme: Week 22
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 22
|
|
Time below range
Tidsramme: Week 26
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 26
|
|
Time below range
Tidsramme: Week 30
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 30
|
|
Time below range
Tidsramme: Week 34
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 34
|
|
Time below range
Tidsramme: Week 37
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 37
|
|
Mean sensor glycemia
Tidsramme: Week 18
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Mean sensor glycemia
Tidsramme: Week 22
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Mean sensor glycemia
Tidsramme: Week 26
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Mean sensor glycemia
Tidsramme: Week 30
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Mean sensor glycemia
Tidsramme: Week 34
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Mean sensor glycemia
Tidsramme: Week 37
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
Coefficient of variation (%CV)
Tidsramme: Week 18
|
Metric of glycemic variability measured by the sensor (%)
|
Week 18
|
|
Coefficient of variation (%CV)
Tidsramme: Week 22
|
Metric of glycemic variability measured by the sensor (%)
|
Week 22
|
|
Coefficient of variation (%CV)
Tidsramme: Week 26
|
Metric of glycemic variability measured by the sensor (%)
|
Week 26
|
|
Coefficient of variation (%CV)
Tidsramme: Week 30
|
Metric of glycemic variability measured by the sensor (%)
|
Week 30
|
|
Coefficient of variation (%CV)
Tidsramme: Week 34
|
Metric of glycemic variability measured by the sensor (%)
|
Week 34
|
|
Coefficient of variation (%CV)
Tidsramme: Week 37
|
Metric of glycemic variability measured by the sensor (%)
|
Week 37
|
|
Standard deviation (SD)
Tidsramme: Week 18
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Standard deviation (SD)
Tidsramme: Week 22
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Standard deviation (SD)
Tidsramme: Week 26
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Standard deviation (SD)
Tidsramme: Week 30
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Standard deviation (SD)
Tidsramme: Week 34
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Standard deviation (SD)
Tidsramme: Week 37
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
HbA1C
Tidsramme: Week 18
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 18
|
|
HbA1C
Tidsramme: Week 22
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 22
|
|
HbA1C
Tidsramme: Week 26
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 26
|
|
HbA1C
Tidsramme: Week 30
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 30
|
|
HbA1C
Tidsramme: Week 34
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 34
|
|
HbA1C
Tidsramme: Week 37
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 37
|
|
Severe hypoglycemia episodes
Tidsramme: From recruitment until delivery.
|
Number of episodes of self-reported severe hypoglycemia.
|
From recruitment until delivery.
|
|
Gestational weight gain
Tidsramme: From recruitment until delivery
|
Maternal gestational weight gain (kg)
|
From recruitment until delivery
|
|
Gestational weight gain from pre-pregnancy
Tidsramme: From pre-pregnancy until delivery
|
Self-reported maternal gestational weight gain (kg)
|
From pre-pregnancy until delivery
|
|
Pregnancy hypertensive disorders
Tidsramme: From recruitment until delivery
|
Preeclampsia, Eclampsia, Gestational hypertension
|
From recruitment until delivery
|
|
The mode of delivery
Tidsramme: At delivery
|
Vaginal, c-section, spontaneous, induction of labor
|
At delivery
|
|
Birth trauma
Tidsramme: At delivery
|
IADPSG criteria
|
At delivery
|
|
Gestational birth weight
Tidsramme: At delivery
|
Neonatal birth weight in grams
|
At delivery
|
|
Macrosomia
Tidsramme: At delivery
|
Gestational birth weight >4200g
|
At delivery
|
|
Large-for-gestational-age (LGA)
Tidsramme: At delivery
|
Neonatal birth weight >90th percentile
|
At delivery
|
|
Small-for-gestational-age (SGA)
Tidsramme: At delivery
|
Neonatal birth weight >10th percentile
|
At delivery
|
|
Placental weight
Tidsramme: At delivery
|
Measured in grams
|
At delivery
|
|
Gestational age
Tidsramme: At delivery
|
Timing of delivery
|
At delivery
|
|
Preterm birth
Tidsramme: At delivery
|
<37 weeks
|
At delivery
|
|
Number of neonates with respiratory distress syndrome
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From week 22
|
Pregnancy loss after 22 weeks
|
From week 22
|
|
Neonatal length of hospital stay
Tidsramme: 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)
Tidsramme: 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
Tidsramme: At delivery
|
Umbilical pH <7.15
|
At delivery
|
|
Apgar score
Tidsramme: At delivery
|
Apgar score <8
|
At delivery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ewa Wender-Ozegowska, Prof. MD PhD, Poznan University of Medical Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. maj 2026
Primær færdiggørelse (Anslået)
1. oktober 2028
Studieafslutning (Anslået)
1. februar 2029
Datoer for studieregistrering
Først indsendt
6. maj 2026
Først indsendt, der opfyldte QC-kriterier
15. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 599_25
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