Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching

Not Applicable

Recruiting

• Conditions: Pregnancy in Diabetic; Pre-Gestational Diabetes; Type2diabetes; Pregnancy, High Risk
• Interventions: Device: DEXCOM G7 PRO Continuous Glucose Monitor; Device: Patient mHealth app linked to a provider dashboard; Behavioral: Care team coaching for medical and social needs (HUB); Device: Provider dashboard

• Registration Number: NCT05662462
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Study Start: 2024-07-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-29
• Primary Completion: 2028-05
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 124

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACHIEVE Intervention	Patient mHealth app linked to a provider dashboard	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.
ACHIEVE Intervention	Care team coaching for medical and social needs (HUB)	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.
ACHIEVE Intervention	DEXCOM G7 PRO Continuous Glucose Monitor	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.
ACHIEVE Intervention	Provider dashboard	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.

Primary Outcome Measures

Name	Time	Method
The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery	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.

Secondary Outcome Measures

Name	Time	Method
Preterm birth <37 weeks	At birth
Neonatal hypoglycemia	48 hours of delivery	Any blood glucose \<30 mg/dL within 48 hours of delivery
NICU admission	Delivery admission	NICU admission for any indication
Large for gestational age at birth	At birth	Birthweight \>90% for gestational age using a 2017 NCHS reference standard
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	Patient intervention tool technology engagement data will be collected through Log files and will be measured as the number of sessions a participant had with the tool (total and average use for tool and specific functions).
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	Provider dashboard and HUB data (for intervention group) and EHR referral and chart notes by licensed social worker (standard of care group).
eHealth literacy scale (eHEALS)	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)	8-item measure of eHealth literacy.
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	Among participants in the intervention arm, we will assess CGM measures of glycemic control.
Health care utilization	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total	Scheduled prenatal clinic visits, hospitalizations, emergency department visits, obstetric triage visits, and unscheduled clinic visits through EHR. Data will be collected from the electronic health record and patient survey.
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.	Comprehension of education material will be measured through Self-developed survey. This is a PRO.
Self-efficacy for Diabetes	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.	Self-efficacy will be measured through the Diabetes Management Self-Efficacy Scale. This is a PRO. Continuous measure or mean score of 8 items.
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	Among participants in the intervention arm, we will assess CGM measures of glycemic control. The target range will be between 63 to 140 mg/dL, consistent with the CONCEPTT CGM trial in pregnant individuals with T1D, emerging data in pregnancy, and expert opinion. We will assess TIR as both a continuous and dichotomous measure (≥85%).
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	Among participants in the intervention arm, we will assess CGM measures of glycemic control.
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	Among participants in the intervention arm, we will assess CGM measures of glycemic control.
Patient activation measure (PAM)	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)	These outcomes will be measured by survey to capture knowledge, skill, and confidence to manage one's health and health care 13-items, continuous scale measures from 0 to 100. This is a PRO.
Diabetes Distress Scale (DDS)	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)	Diabetes Distress will be measured through the Diabetes Distress Scale. This is a PRO. The DDS is a self-report survey that has 17 items.
Blood glucose levels	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total	EHR data and mHealth app (CGM)(for the intervention group) and self-monitored blood glucose (for standard of care group)
Diabetes Knowledge Questionnaire (DKQ)	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)	Measured through Patient's Diabetes Knowledge Questionnaire. This is a PRO. 24 item scale, continuous measure.
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	Adherence will be measured through Medication Adherence Scale. This is a PRO
Doctor-Patient Communication Scale	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total	The questionnaire contains 15 items with 4 possible answers: no, possibly no, possibly yes, and yes, rated according to a Likert-type scale (1 to 4 points), with score of 4 being the best possible response.
Short Assessment of Health Literacy-Spanish and English (SAHL-S&E)	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)	Health literacy will be measured through eHealth literacy scale and Health literacy scale. This is a PRO. A score between 0 and 14 suggests the examinee has low health literacy.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine; 🇺🇸 Columbus, Ohio, United States