Type 2 Diabetes and Pregnancy a Single-arm Interventional Study (pUMPreg2)
15. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ewa Wender-Ozegowska, Prof. MD PhD
- Telefonnummer: +48 (61) 841-93-02
- E-post: ewozegow@ump.edu.pl
Studiesteder
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polen, 60-535
- Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
-
Ta kontakt med:
- Ewa Wender-Ozegowska, Prof. MD PhD
- Telefonnummer: +48 (61) 841-93-02
- E-post: ewozegow@ump.edu.pl
-
Hovedetterforsker:
- Ewa Wender-Ozegowska, Prof. MD PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ewa Wender-Ozegowska, Prof. MD PhD, Poznan University of Medical Sciences
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. oktober 2028
Studiet fullført (Antatt)
1. februar 2029
Datoer for studieregistrering
Først innsendt
6. mai 2026
Først innsendt som oppfylte QC-kriteriene
15. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 599_25
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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