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

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.

Participant will know what arm they are randomized to, participants and physicians in Arm 2 will be blinded to CGM data collected for 10 days at 2 timepoints.

Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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