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

Overview

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.

Interventions

• Device DEXCOM G7 PRO Continuous Glucose Monitor
  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 c
• Device Patient mHealth app linked to a provider dashboard
  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 resource
• Behavioral Care team coaching for medical and social needs (HUB)
  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
• Device Provider dashboard
  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 m

Primary outcome measures

• The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery [Time frame: From ≤20 weeks of gestation to delivery, an average of 5 months]

Secondary outcome measures (12)

• Large for gestational age at birth [Time frame: At birth]
• Neonatal hypoglycemia [Time frame: 48 hours of delivery]
• NICU admission [Time frame: Delivery admission]
• Preterm birth <37 weeks [Time frame: At birth]
• Respiratory distress syndrome [Time frame: Delivery admission]
• Percentage of time-in-range (TIR) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total]
• Patient activation measure (PAM) [Time frame: Once per trimester (~12 weeks, 24 weeks, and 36 weeks)]
• Patient intervention tool technology engagement [Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total]
• The Accountable Health Communities. Health-Related Social Needs Screening Tool [Time frame: Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total]

Eligibility criteria

Inclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

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

Publications

• 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/bmjope PMID 37164461

Identifiers

NCT: NCT05662462 · 2022H0399

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗