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

Type2diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05662462
• Other study ID #: 2022H0399
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: March 2029

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: Kartik Venkatesh, MD, PhD
• Phone: 614-293-2222
• Email: kartik.venkatesh[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 three 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: March 2029
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. pregnant individuals age =18 years;

2. =20 weeks of gestation;

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;

10. not currently using a CGM device.

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Pre-Gestational Diabetes
• Pregnancy in Diabetic
• Pregnancy in Diabetics
• Pregnancy, High Risk

Intervention

Device:
• DEXCOM G6 PRO Continuous Glucose Monitor
Participants in the intervention arm will be provided with DEXCOM® G6 PRO CGM sensors and transmitters. The Dexcom G6 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® G6 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
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.

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 participants to community resources through "care pathways," a defined action plan addressing patient needs which is recorded and tracked.

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 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	Agency for Healthcare Research and Quality (AHRQ), DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Large for gestational age at birth	Birthweight >90% for gestational age using a 2017 NCHS reference standard	At birth
Secondary	Neonatal hypoglycemia	Any blood glucose <30 mg/dL within 48 hours of delivery	48 hours of delivery
Secondary	NICU admission	NICU admission for any indication	Delivery admission
Secondary	Preterm birth <37 weeks		At birth
Secondary	Respiratory distress syndrome		Delivery admission
Secondary	Percentage of time-in-range (TIR)	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%).	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Mean CGM glucose levels during the day and night	Among participants in the intervention arm, we will assess CGM measures of glycemic control.	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Time spent above and below target range	Among participants in the intervention arm, we will assess CGM measures of glycemic control.	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Low and high blood glucose indices	Among participants in the intervention arm, we will assess CGM measures of glycemic control.	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Patient activation measure (PAM)	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.	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Secondary	Patient intervention tool technology engagement	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).	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	The Accountable Health Communities. Health-Related Social Needs Screening Tool	Provider dashboard and HUB data (for intervention group) and EHR referral and chart notes by licensed social worker (standard of care group).	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Blood glucose levels	EHR data and mHealth app (CGM)(for the intervention group) and self-monitored blood glucose (for standard of care group)	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Diabetes Knowledge Questionnaire (DKQ)	Measured through Patient's Diabetes Knowledge Questionnaire. This is a PRO. 24 item scale, continuous measure.	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Secondary	Morisky Medication Adherence Scale (MMAS-8)	Adherence will be measured through Medication Adherence Scale. This is a PRO	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Health care utilization	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.	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total
Secondary	Short Assessment of Health Literacy-Spanish and English (SAHL-S&E)	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.	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Secondary	eHealth literacy scale (eHEALS)	8-item measure of eHealth literacy.	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Secondary	Comprehension of education material	Comprehension of education material will be measured through Self-developed survey. This is a PRO.	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.
Secondary	Diabetes Distress Scale (DDS)	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.	Once per trimester (~12 weeks, 24 weeks, and 36 weeks)
Secondary	Self-efficacy for Diabetes	Self-efficacy will be measured through the Diabetes Management Self-Efficacy Scale. This is a PRO. Continuous measure or mean score of 8 items.	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.
Secondary	Doctor-Patient Communication Scale	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.	Across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total