Type 2 Diabetes and Pregnancy a Single-arm Interventional Study
Pregnancy · Type 2 Diabetes
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 45 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- No aceptados
- Participantes
- 20 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Women with diagnosed pregestational type 2 diabetes or HbA1c \>6.5% in the 1st trimester (ADA, PTD)
2. Age 18-45 years
3. Gestational age of 16 weeks +0 days or less at baseline
4. Singleton pregnancy
5. HbA1c at baseline 5.0-10%
6. A viable pregnancy at the recruitment
7. Willingness to continue the treatment until delivery in the clinic
Exclusion Criteria:
1. Other types of diabetes including T1D and Monogenic diabetes
2. Major fetal congenital defects
3. Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial
4. Pump therapy before pregnancy
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Type 2 diabetes
Pregnant patients with type 2 diabetes treated with automated insulin delivery system
Device: Automated insulin delivery system - Medtronic 780G
Automated insulin delivery system - Medtronic 780G DEVICE
Use of automated insulin delivery system in pregnant patients with type 2 diabetes
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Time in range
Plazo: From enrollment to the delivery
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Mean sensor glycemia
Plazo: From enrollment to the delivery
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Medidas secundarias
Time in range
Plazo: Week 18
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Plazo: Week 22
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Plazo: Week 26
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Plazo: Week 30
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Plazo: Week 34
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in range
Plazo: Week 37
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
Time in tight range
Plazo: Week 18
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Plazo: Week 22
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Plazo: Week 26
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Plazo: Week 30
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Plazo: Week 34
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Time in tight range
Plazo: Week 37
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
Change in the time in range values
Plazo: 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)
Time above range
Plazo: Week 18
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Plazo: Week 22
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Plazo: Week 26
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Plazo: Week 30
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Plazo: Week 34
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above range
Plazo: Week 37
Percentage of time spent above target glucose values - \>140 mg/dL (\>7.8 mmol/L)
Time above tight range
Plazo: Week 18
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Plazo: Week 22
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Plazo: Week 26
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Plazo: Week 30
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Plazo: Week 34
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time above tight range
Plazo: Week 37
Percentage of time spent above target glucose values - \>120 mg/dL (\>6.7 mmol/L)
Time below range
Plazo: Week 18
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Plazo: Week 22
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Plazo: Week 26
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Plazo: Week 30
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Plazo: Week 34
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Time below range
Plazo: Week 37
Percentage of time spent below target glucose values - \<63 mg/dL (\<3.5 mmol/L)
Mean sensor glycemia
Plazo: Week 18
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Plazo: Week 22
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Plazo: Week 26
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Plazo: Week 30
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Plazo: Week 34
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Mean sensor glycemia
Plazo: Week 37
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
Coefficient of variation (%CV)
Plazo: Week 18
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Plazo: Week 22
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Plazo: Week 26
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Plazo: Week 30
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Plazo: Week 34
Metric of glycemic variability measured by the sensor (%)
Coefficient of variation (%CV)
Plazo: Week 37
Metric of glycemic variability measured by the sensor (%)
Standard deviation (SD)
Plazo: Week 18
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Plazo: Week 22
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Plazo: Week 26
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Plazo: Week 30
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Plazo: Week 34
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
Standard deviation (SD)
Plazo: Week 37
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
HbA1C
Plazo: Week 18
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Plazo: Week 22
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Plazo: Week 26
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Plazo: Week 30
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Plazo: Week 34
Blood glycated hemoglobin measurement (% and mmol/mol)
HbA1C
Plazo: Week 37
Blood glycated hemoglobin measurement (% and mmol/mol)
Severe hypoglycemia episodes
Plazo: From recruitment until delivery.
Number of episodes of self-reported severe hypoglycemia.
Gestational weight gain
Plazo: From recruitment until delivery
Maternal gestational weight gain (kg)
Gestational weight gain from pre-pregnancy
Plazo: From pre-pregnancy until delivery
Self-reported maternal gestational weight gain (kg)
Pregnancy hypertensive disorders
Plazo: From recruitment until delivery
Preeclampsia, Eclampsia, Gestational hypertension
The mode of delivery
Plazo: At delivery
Vaginal, c-section, spontaneous, induction of labor
Birth trauma
Plazo: At delivery
IADPSG criteria
Gestational birth weight
Plazo: At delivery
Neonatal birth weight in grams
Macrosomia
Plazo: At delivery
Gestational birth weight \>4200g
Large-for-gestational-age (LGA)
Plazo: At delivery
Neonatal birth weight \>90th percentile
Small-for-gestational-age (SGA)
Plazo: At delivery
Neonatal birth weight \<10th percentile
Placental weight
Plazo: At delivery
Measured in grams
Gestational age
Plazo: At delivery
Timing of delivery
Preterm birth
Plazo: At delivery
\<37 weeks
Number of neonates with respiratory distress syndrome
Plazo: 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.
Number of neonates with jaundice requiring phototherapy
Plazo: 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.
Number of neonates with neonatal hypoglycemia
Plazo: 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
Stillbirth
Plazo: From week 22
Pregnancy loss after 22 weeks
Neonatal length of hospital stay
Plazo: From date of delivery until the date of hospital discharge, assessed up to 20 weeks
Duration of neonatal hospitalization, measured in days
Length of stay in the neonatal intensive care unit (NICU)
Plazo: From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
Duration of NICU stay, measured in days
Neonatal acidosis
Plazo: At delivery
Umbilical pH \<7.15
Apgar score
Plazo: At delivery
Apgar score \<8
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical SciencesPoznan, Wielkopolska, PolandReclutando
Equipo y fechas
- Patrocinador principal
- Poznan University of Medical Sciences
- Inicio del estudio
- 8 may 2026 Real
- Finalización primaria
- 2028-10 Estimado
- Finalización del estudio
- 2029-02 Estimado
- Primera publicación
- 22 may 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Type 2 Diabetes and Pregnancy a Single-arm Interventional Study
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026