Clinical trial NCT05370612: AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
Official title: Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2Diabetes
Pregnancy in Diabetic
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-05-11
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot, prospective, randomized trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility: Number of Participants Who Complete the Study within 24 month time period
timeFrame: up to 24 months
measure: Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences with Diabetes Management
timeFrame: at enrollment, 28-32 weeks gestation (up to 12 weeks on study), postpartum (up to 26 weeks on study)
measure: Percentage of Time Where Blood Glucose is between 70-140 milligrams per deciliter (mg/dL)
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Number of Participants with Cesarean Delivery
timeFrame: approximately 20 weeks on study (at time of delivery)
measure: Change in hemoglobin A1c (percentage) from initiation to third trimester
timeFrame: baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation)
measure: Percentage of time spent in hyperglycemic range
timeFrame: up to 26 weeks
measure: Percentage of time spent in hypoglycemic range
timeFrame: up to 26 weeks
measure: Rates of gestational hypertension
timeFrame: up to approximately 20 weeks on study
measure: Rates of preeclampsia
timeFrame: up to approximately 20 weeks on study
measure: Rates of polyhydramnios
timeFrame: up to approximately 20 weeks on study
measure: Incidence of neonatal hypoglycemia
timeFrame: up to 26 weeks
measure: Rates of fetal macrosomia
timeFrame: up to 26 weeks
measure: Rates of NICU Admission
timeFrame: up to 26 weeks
measure: Rates of spontaneous preterm delivery
timeFrame: up to approximately 17 weeks on study (less than 37 weeks gestation)
measure: Satisfaction and Quality of Life Survey Scores (5-point likert scale)
timeFrame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
measure: Satisfaction and Quality of Life Survey Scores (7-point likert scale)
timeFrame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
measure: Satisfaction and Quality of Life Survey Scores (Participant Counts)
timeFrame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
measure: Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
timeFrame: 2-4 weeks postpartum (up to 26 weeks on study)
measure: Qualitative Outcome: Interviews to understand Participant Sense of Control around Glucose Monitoring
timeFrame: 2-4 weeks postpartum (up to 26 weeks on study)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Jacquelyn H Adams, MD
role: PRINCIPAL_INVESTIGATOR
References: