AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
- Conditions
- Pregnancy in DiabeticType2Diabetes
- Registration Number
- NCT05370612
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
- Detailed Description
This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes.
The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms.
* Arm 1: Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for duration of pregnancy
* Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks gestation)
Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well.
* Primary Objective
* To examine the feasibility of completing a study to assess for differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes.
* Secondary Objectives
* To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-32 weeks of pregnancy.
* To assess patient satisfaction to continuous glucose monitoring during pregnancy
* To estimate the effect of continuous glucose monitoring on the incidence of neonatal morbidity and mortality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
- Age greater than or equal to 18 years of age at enrollment
- Ability to consent in English
- Gestational age less than or equal to 19 weeks 6 days at enrollment
- Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day
- Diagnosis of Type 2 Diabetes less than or equal to 19 weeks 6 days
- Singleton gestation
- Age less than 18 years of age at enrollment
- Lack of appropriate dating
- Multiple gestations
- Use of concentrated insulin at enrollment (ie U500)
- Preexisting CGM in place
- Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and inhaled, injectable and oral corticosteroids
- Be unwilling or unable to present to Center for Perinatal Care for visits
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility: Number of Participants Who Complete the Study within 24 month time period up to 24 months Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is.
Percentage of Time Where Blood Glucose is between 70-140 milligrams per deciliter (mg/dL) up to 26 weeks The primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM.
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences with Diabetes Management at enrollment, 28-32 weeks gestation (up to 12 weeks on study), postpartum (up to 26 weeks on study) Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content.
- Secondary Outcome Measures
Name Time Method Rates of fetal macrosomia up to 26 weeks Actual birthweight greater than 95 percent by Fenton growth curve for newborns
Percentage of time spent in hypoglycemic range up to 26 weeks Hypoglycemic range is considered less than 70 mg/dL.
Rates of preeclampsia up to approximately 20 weeks on study Gestational hypertension plus either new-onset proteinuria \[300 mg/24 hours, protein:creatinine 0.3 mg/dL\], thrombocytopenia \[platelet count\<100,000/uL\], elevated Aspartate transaminase or alanine transaminase \[\>2 upper limit of normal\], renal insufficiency \[serum creatinine\>1.1 mg/dL or an unexplained doubling of creatinine\], pulmonary edema, or cerebral or visual symptoms.
Rates of polyhydramnios up to approximately 20 weeks on study Satisfaction and Quality of Life Survey Scores (Participant Counts) at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Survey questions include answers on a 5-point likert scale, 7-point likert scale, and participant count data. Survey questions scored as participant counts are reported here.
Incidence of neonatal hypoglycemia up to 26 weeks Satisfaction and Quality of Life Survey Scores (5-point likert scale) at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Survey questions include answers on a 5-point likert scale, 7-point likert scale, and participant count data. Survey questions scored on a 5-point likert scale are reported here where higher scores indicated increased satisfaction and quality of life.
Change in hemoglobin A1c (percentage) from initiation to third trimester baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation) Rates of gestational hypertension up to approximately 20 weeks on study Gestational hypertension is defined as systolic blood pressure 140 mm Hg or diastolic blood pressure 90 mg Hg on two occasions at least 4 hours apart.
Rates of spontaneous preterm delivery up to approximately 17 weeks on study (less than 37 weeks gestation) Preterm delivery is considered less than 37 weeks.
Qualitative Outcome: Interviews to understand Participant Sense of Control around Glucose Monitoring 2-4 weeks postpartum (up to 26 weeks on study) Explore if traditional management versus continuous glucose management has higher feelings of control over diabetes management. The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.
Satisfaction and Quality of Life Survey Scores (7-point likert scale) at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Survey questions include answers on a 5-point likert scale, 7-point likert scale, and participant count data. Survey questions scored on a 7-point likert scale are reported here where higher scores indicated increased satisfaction and quality of life.
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings 2-4 weeks postpartum (up to 26 weeks on study) The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.
Number of Participants with Cesarean Delivery approximately 20 weeks on study (at time of delivery) Percentage of time spent in hyperglycemic range up to 26 weeks Hyperglycemic range is considered greater than 140 mg/dL
Rates of NICU Admission up to 26 weeks
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Wisconsin🇺🇸Madison, Wisconsin, United States