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Clinical Trial Details

Trial ID: L6347
Source ID: NCT05922033
Associated Drug: Patient-Led Insulin (Intervention Group)
Title: Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Gestational Diabetes Mellitus|Pregnancy in Diabetic|Pregnancy, High Risk
Interventions: DRUG: Patient-led Insulin (intervention group)|DRUG: Provider-led Insulin (standard care)
Outcome Measures: Primary: Fasting glycemic control, Continuous measure of mean fasting glucose during the 36th week of pregnancy. Patients with have the mean fasting glucose value during the 36th week of pregnancy. We will use this goal given that inadequate glycemic control may be delivered as soon as the early term period (37-39 weeks) or patients may also have spontaneous or iatrogenic preterm delivery. If the patient delivers before the 36th week or does not have data available in the 36th week, we will use the last available week of data If the patient does not have glucose log in the 36th week, we will use the most proximal week such as the 37th week., From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation | Secondary: Birth weight in grams, continuous measure birthweight in grams of neonate of the pregnancy as recorded in the delivery record, At birth|Fasting blood glucose >50% at target within the past week, categorical measure of fasting BG at target. Fasting blood glucose at target (\>95) in greater than 50% of recorded values with in the past week, From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation|Postprandial blood glucose >50% at target within the past week, categorical measure of fasting BG at target. Postprandial blood glucose \>50% at target (\<140 at 1 hour postprandial or \<120 at 2 hour postprandial) within the past week, From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation|Average fasting blood glucose, Continuous measure of average fasting blood glucose. Average fasting blood glucose for each week of the pregnancy from randomization until delivery, From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation|Average postprandial blood glucose, Continuous measure of average postprandial blood glucose. Average fasting blood glucose for each week of the pregnancy from randomization until delivery, From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation|Maternal hypoglycemia events, Number of maternal hypoglycemia events defined as percent fasting glucose below 60, From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation|Total insulin usage (units/kg/day), continuous measure total insulin usage at time of delivery, at time of delivery approximately from 36 weeks to 39 weeks gestation|Composite perinatal outcomes (large for gestational age, neonatal hypoglycemia, NICU admission), categorical measure of the presence composite outcomes of large for gestational age, and neonatal hypoglycemia and NICU admissions of as a result of pregnancy., At birth|Neonatal hypoglycemia, categorical measure if neonatal hypoglycemia is present as defined as blood glucose \<35 mg/dL requiring glucose treatment in the first 24 hours of birth, at birth until 24 hours birth|NICU admissions, categorical measure if neonate is admitted to the neonatal intensive care unit for any indication at birth or until discharge of neonate, Any NICU admission for 48 hours or greater duration up to 2-3 months|Preterm birth <34 weeks for any indication, categorical measure of the presence of delivery before 34 weeks either spontaneous or iatrogenic, At birth|Preterm birth <37 weeks for any indication, categorical measure of the presence of delivery before 37 weeks either spontaneous or iatrogenic, At birth|Hypertensive disorder of pregnancy, categorical measure of the presence of the diagnosis of hypertensive disorder of pregnancy including gestational hypertension, preeclampsia with and without severe features, and superimposed preeclampsia, eclampsia, and HELLP syndrome as defined by ACOG guidelines, From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation|Large for gestational age, Categorical measure if neonate is large for gestational age as defined by 90th percentile for birthweight standardized by gestational age and sex, At birth|Demographics and logistic barriers survey, continuous measure of survey from the demographics and logistic barriers survey, after the 36th week until delivery|Diabetes Treatment Satisfaction Questionnaire (DTSQ), continuous measure of survey information from Diabetes Treatment Satisfaction Questionnaire (DTSQ) assessing patients' satisfaction with their diabetes treatment, after the 36th week until delivery|Diabetes Distress Screening (DDS) Scale, continuous measure of survey Diabetes Distress Screening (DDS) Scale assessing the severity of the distress with living with gestational diabetes, after the 36th week until delivery
Sponsor/Collaborators: Sponsor: Ohio State University
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-10-19
Completion Date: 2025-06
Results First Posted:
Last Update Posted: 2025-02-25
Locations: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus, Ohio, 43210, United States
URL: https://clinicaltrials.gov/show/NCT05922033