Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility: Number of Participants Who Complete the Study within 24 month time period
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility: Number of Participants Who Complete the Study within 24 month time period
时间窗: 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.
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences with Diabetes Management
时间窗: 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.
Percentage of Time Where Blood Glucose is between 70-140 milligrams per deciliter (mg/dL)
时间窗: 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.
次要结局
- Rates of fetal macrosomia(up to 26 weeks)
- 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)
- Percentage of time spent in hypoglycemic range(up to 26 weeks)
- Rates of preeclampsia(up to approximately 20 weeks on study)
- 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))
- 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))
- 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)
- Rates of NICU Admission(up to 26 weeks)
- Rates of spontaneous preterm delivery(up to approximately 17 weeks on study (less than 37 weeks gestation))
- Qualitative Outcome: Interviews to understand Participant Sense of Control around Glucose Monitoring(2-4 weeks postpartum (up to 26 weeks on study))
- 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))
- 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))