ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery
研究概览
简要总结
The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c <6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c <6.5% in the third trimester compared to the standard care group
详细描述
Type 2 diabetes (T2D) in pregnancy increases the risk of adverse outcomes for both the mother and infant. Over 1 in 3 infants born to individuals with T2D will experience an adverse outcome, including large for gestational age at birth, preterm birth, birth trauma, neonatal hypoglycemia, and stillbirth. Strict maternal glycemic control throughout pregnancy is key to optimizing perinatal outcomes. This is possible with insulin pharmacotherapy, vigilant glucose monitoring, lifestyle modifications including diet and exercise, and team-based prenatal care. Medicaid-enrolled pregnant individuals with T2D experience non-medical social needs that limit their ability to achieve glycemic control, including lack of reliable transportation to attend prenatal visits, access to resources to engage in diet and exercise changes, and convenient methods to log self-monitored glucose values and adjust insulin dosing.
A multi-faceted provider-patient based approach is needed with proven strategies to improve glycemic control. We propose "ACHIEVE: Successfully achieving and maintaining euglycemia during pregnancy for type 2 diabetes through technology and coaching." Our intervention is multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. This intervention empowers Medicaid-enrolled pregnant individuals with T2D and their healthcare providers to achieve and maintain glycemic control, improve access to care, and provide patient education and support. Each sub-component of the proposed intervention is grounded in Social Cognitive Theory (SCT), and emphasizes on individuals' skills, knowledge and beliefs, and self-efficacy to achieve glycemic control.
We propose four aims: AIM 1: Develop the tailored ACHIEVE mHealth app and provider dashboard for Medicaid-enrolled pregnant individuals with T2D and their healthcare team through active stakeholder engagement; AIM 2: Conduct an RCT and measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c <6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c <6.5% in the third trimester compared to the standard care group; and AIM 3: Identify multi-level patient and provider barriers and facilitators to satisfaction, engagement, and use of the intervention and its subcomponents. AIM 4: Examine postpartum (i.e. 6-12 months after delivery) diabetes and reproductive health outcomes in both intervention and standard care arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment of the primary outcome of glycemic control (Hemoglobin A1c <6.5%) will assessed blinded to study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant individuals age ≥18 years;
- •≤20 weeks of gestation (specifically, <20+6 weeks);
- •diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
- •Medicaid insurance;
- •English or Spanish speaking;
- •cognitively able to complete the study requirements;
- •consent to all study activities;
- •accessible for participation in study activities;
- •use a smartphone with internet access;
- •Participants must also consent to the study team abstracting information from their electronic health records (EHRs), using CGM for glucose monitoring if randomized to the intervention group, tracking the participants' clinic, hospital, and emergency room visits during the study period, as well as tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application (app), including what activities are used in the mobile application (e.g., recording blood glucose, scheduling appointments, messaging their healthcare providers, accessing educational resources).
排除标准
- 未提供
研究组 & 干预措施
Standard of care
Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support.
ACHIEVE Intervention
The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.
干预措施: DEXCOM G7 PRO Continuous Glucose Monitor (Device)
ACHIEVE Intervention
The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.
干预措施: Patient mHealth app linked to a provider dashboard (Device)
ACHIEVE Intervention
The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.
干预措施: Care team coaching for medical and social needs (HUB) (Behavioral)
ACHIEVE Intervention
The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.
干预措施: Provider dashboard (Device)
结局指标
主要结局
The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery
时间窗: From ≤20 weeks of gestation to delivery, an average of 5 months
A1c is a blood test that represents the average glucose over the previous three months. Our outcome threshold is slightly higher than the target of \<6.0 recently recommended by ADA because: 1) our target population of pregnant individuals includes those with poor glycemic control at enrollment, 2) an aggressive target \<6% can result in frequent episodes of hypoglycemia, of particular concern for participants in the standard care arm without CGM, and 3) the frequency of adverse neonatal outcomes are similar with third trimester A1c 6-6.4% vs. \<6%. A1c will be assessed once per trimester, consistent with ADA and ACOG guidelines for T2D management in pregnancy, and at delivery. For participants with \>1 value in the third trimester, the value closest to delivery will be used. A standard assay will be used for HbA1c. We will evaluate HbA1c as an absolute percentage of total hemoglobin using reference standards per the Diabetes Control and Complications Trial Reference Method.
次要结局
- Self-efficacy for Diabetes(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.)
- Time spent above and below target range(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Low and high blood glucose indices(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Patient activation measure (PAM)(Once per trimester (~12 weeks, 24 weeks, and 36 weeks))
- Large for gestational age at birth(At birth)
- Preterm birth <37 weeks(At birth)
- Neonatal hypoglycemia(48 hours of delivery)
- NICU admission(Delivery admission)
- Patient intervention tool technology engagement(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Respiratory distress syndrome(Delivery admission)
- The Accountable Health Communities. Health-Related Social Needs Screening Tool(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Mean CGM glucose levels during the day and night(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Health care utilization(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Comprehension of education material(3 times in the first six weeks and then monthly during study participation, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.)
- Percentage of time-in-range (TIR)(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Diabetes Distress Scale (DDS)(Once per trimester (~12 weeks, 24 weeks, and 36 weeks))
- Blood glucose levels(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Diabetes Knowledge Questionnaire (DKQ)(Once per trimester (~12 weeks, 24 weeks, and 36 weeks))
- Morisky Medication Adherence Scale (MMAS-8)(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Doctor-Patient Communication Scale(Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total)
- Short Assessment of Health Literacy-Spanish and English (SAHL-S&E)(Once per trimester (~12 weeks, 24 weeks, and 36 weeks))
- eHealth literacy scale (eHEALS)(Once per trimester (~12 weeks, 24 weeks, and 36 weeks))
研究者
Kartik K Venkatesh
Associate Professor
Ohio State University