AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy

University of Wisconsin, Madison16 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Type2Diabetes Pregnancy in Diabetic

Interventions

Dexcom G6 CGMDEVICE

Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data. Experimental Group will wear CGM for the duration of their pregnancy. Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy.

Participant Finger Stick Glucose MonitoringOTHER

Standard of care for individual participant

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period

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.

Time frame: up to 24 months

Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management

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. Higher numbers indicate higher satisfaction with diabetes management.

Time frame: baseline, 12 weeks on study, and postpartum (up to 26 weeks on study)

Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range

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.

Time frame: Baseline, 26 weeks

Secondary Outcomes

Number of Participants With Cesarean Delivery

Time frame: approximately 20 weeks on study (at time of delivery)

Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester

Time frame: baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Percentage of Time Spent in Hyperglycemic Range

Hyperglycemic range is considered greater than 140 mg/dL. A very high hyperglycemic range is \>250mg/dL.

Time frame: up to 26 weeks

Percentage of Time Spent in Hypoglycemic Range

Hypoglycemic range is considered less than 70 mg/dL. Low is 55-70, very low is \<54.

Time frame: 26 weeks

Rates of Gestational Hypertension

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.

Time frame: up to approximately 20 weeks on study

Rates of Preeclampsia

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.

Time frame: up to approximately 20 weeks on study

Rates of Polyhydramnios

Time frame: up to approximately 20 weeks on study

Incidence of Neonatal Hypoglycemia

Time frame: up to 26 weeks

Rates of Fetal Macrosomia

Actual birthweight greater than 95 percent by Fenton growth curve for newborns

Time frame: up to 26 weeks

Rates of NICU Admission

Time frame: up to 26 weeks

Rates of Spontaneous Preterm Delivery

Preterm delivery is considered less than 37 weeks.

Time frame: up to approximately 17 weeks on study (less than 37 weeks gestation)

Satisfaction and Quality of Life Survey Scores (5-point Likert Scale)

Satisfaction and Quality of Life survey will be administered and answers will be compared between groups. Survey questions include answers on a 5-point Likert scale. Scores range from 15-75, where higher scores indicate lower satisfaction and quality of life, and lower scores indicate higher satisfaction and quality of life.

Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)

Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings

The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.

Time frame: 2-4 weeks postpartum (up to 26 weeks on study)

Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring

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.

Time frame: 2-4 weeks postpartum (up to 26 weeks on study)

Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes?

A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied

Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)

Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level?

Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)

Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks?

Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)

Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment?

Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)

Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes?

Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)