Clinical trial NCT05662462: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Official title: ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Gestational Diabetes
Type2diabetes
Pregnancy in Diabetic
Pregnancy, High Risk
Keywords: mHealth
Pregnancy
Type 2 diabetes
Continuous glucose monitoring
Mobile application
Medicaid
Glycemic control
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: DexCom, Inc.
First posted: 2022-12-22
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. pregnant individuals age ≥18 years;
2. ≤20 weeks of gestation (specifically, \<20+6 weeks);
3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
4. Medicaid insurance;
5. English or Spanish speaking;
6. cognitively able to complete the study requirements;
7. consent to all study activities;
8. accessible for participation in study activities;
9. 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).

Primary outcomes:
measure: The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery
timeFrame: From ≤20 weeks of gestation to delivery, an average of 5 months
Secondary outcomes:
measure: Large for gestational age at birth
timeFrame: At birth
measure: Neonatal hypoglycemia
timeFrame: 48 hours of delivery
measure: NICU admission
timeFrame: Delivery admission
measure: Preterm birth <37 weeks
timeFrame: At birth
measure: Respiratory distress syndrome
timeFrame: Delivery admission
measure: Percentage of time-in-range (TIR)
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Mean CGM glucose levels during the day and night
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Time spent above and below target range
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Low and high blood glucose indices
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Patient activation measure (PAM)
timeFrame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
measure: Patient intervention tool technology engagement
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: The Accountable Health Communities. Health-Related Social Needs Screening Tool
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Blood glucose levels
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Diabetes Knowledge Questionnaire (DKQ)
timeFrame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Health care utilization
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
measure: Short Assessment of Health Literacy-Spanish and English (SAHL-S&E)
timeFrame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
measure: eHealth literacy scale (eHEALS)
timeFrame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
measure: Comprehension of education material
timeFrame: 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.
measure: Diabetes Distress Scale (DDS)
timeFrame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
measure: Self-efficacy for Diabetes
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.
measure: Doctor-Patient Communication Scale
timeFrame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Naleef Fareed, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Joshua J Joseph, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Kartik K Venkatesh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: