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

NCT05662462 | Recruiting FDA Device

• 1 other identifier: 2022H0399
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  From ≤20 weeks of gestation to delivery, an average of 5 months

Secondary Outcomes (22)

• Large for gestational age at birth

  At birth

• Neonatal hypoglycemia

  48 hours of delivery

• NICU admission

  Delivery admission

• Preterm birth <37 weeks

  At birth

• Respiratory distress syndrome

  Delivery admission

Study Arms (2)

ACHIEVE Intervention

ACTIVE COMPARATOR

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.

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

Standard of care

NO INTERVENTION

Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support.

Interventions

DEXCOM G7 PRO Continuous Glucose Monitor DEVICE

Participants in the intervention arm will be provided with DEXCOM® G7 PRO CGM sensors and transmitters. The Dexcom G7 CGM system is accurate and safe in pregnant individuals with diabetes. Participants will be taught how to place and remove CGM sensors by a trained research nurse, and will be given sensors to change themselves at home every 10 days. Of note, the DEXCOM® G7 PRO can be applied as a patch on the abdomen, arm, or upper buttocks, is well-tolerated in pregnancy, and does not require calibration. Our mHealth app will allow for wireless synchronization with the CGM sensor so that data are seamlessly reported back to the healthcare team.

ACHIEVE Intervention

Patient mHealth app linked to a provider dashboard DEVICE

The mHealth app is based on our team's prototype intervention developed at our study site. The mHealth app provides diverse functions, including education, reminders, care goals, care pathway recommendations, CGM data and PROs reporting and monitoring, messaging and video conferencing, and a calendar function. Content is based on clinical guidelines for diabetes in pregnancy. Participants will be directed to appropriate resources and online learning to help them navigate the app and its resources. PROs in the mHealth app will be embedded to address health and social needs, and rule-based algorithms will provide tailored care goals, show care pathways, and establish the frequency of elicited PROs.

ACHIEVE Intervention

Care team coaching for medical and social needs (HUB) BEHAVIORAL

Participants will be screened at enrollment and throughout the intervention for social needs using a survey adapted from validated instruments, such as the Accountable Health Communities Health-Related Social Needs Screening Tool. The care team will refer participants with affirmative responses to the HUB through the provider dashboard to address social needs (e.g., food insecurity, housing, employment). HUB community health workers will perform comprehensive social needs assessments and connect participants to community resources through "care pathways," a defined action plan addressing patient needs which is recorded and tracked.

Also known as: Healthcare Collaborative of Greater Columbus Central Ohio Pathways HUB and social needs

ACHIEVE Intervention

Provider dashboard DEVICE

The ACHIEVE intervention will include a bi-directional dashboard that displays information about individuals, including priority care goals and pathways, and recommendations generated via PROMPT. Healthcare team members can access the dashboard embedded within a portal to modify or update information and close the loop on participant tasks. The dashboard will present recommendations for participant goals and pathways provided by the PROMPT algorithms. Providers can use these recommendations or manually select ones for the participant. Providers can sequence goals and pathways by level of complexity. Both the HUB and the healthcare team can perform ongoing assessments of HUB pathway selections and assess recurring needs through the provider dashboard.

ACHIEVE Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is restricted to pregnant individuals.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• Venkatesh KK, Joseph JJ, Swoboda C, Strouse R, Hoseus J, Baker C, Summerfield T, Bartholomew A, Buccilla L, Pan X, Sieck C, McAlearney AS, Huerta TR, Fareed N. Multicomponent provider-patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study. BMJ Open. 2023 May 10;13(5):e074657. doi: 10.1136/bmjopen-2023-074657.

  PMID: 37164461 DERIVED

MeSH Terms

Conditions

Pregnancy in Diabetics; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Naleef Fareed, PhD, MBA

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Joshua J Joseph, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Kartik K Venkatesh, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kartik Venkatesh, MD, PhD

CONTACT

614-293-2222; kartik.venkatesh@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment of the primary outcome of glycemic control (Hemoglobin A1c \<6.5%) will assessed blinded to study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 22, 2022
• Study Start: July 11, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)