Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
DEXCOM G7 PRO Continuous Glucose Monitor
DeviceParticipants 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.
Patient mHealth app linked to a provider dashboard
DeviceThe 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.
Care team coaching for medical and social needs (HUB)
BehavioralParticipants 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.
Provider dashboard
DeviceThe 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.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: ACHIEVE InterventionActive comparator 4 interventions
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
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.
Time frame
From ≤20 weeks of gestation to delivery, an average of 5 monthsSecondary outcomes
1
Large for gestational age at birth
Birthweight \>90% for gestational age using a 2017 NCHS reference standard
Time frame
At birth2
Neonatal hypoglycemia
Any blood glucose \<30 mg/dL within 48 hours of delivery
Time frame
48 hours of delivery3
NICU admission
NICU admission for any indication
Time frame
Delivery admission4
Preterm birth <37 weeks
Time frame
At birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
DexCom, Inc.
Collaborator
Source ClinicalTrials.gov