Impact of a Digital Self-Management Program on A1C for Individuals With Type 2 Diabetes

Omada Health

Status: Terminated

Conditions: Type 2 Diabetes

Treatments: Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04892680

2020.082-1

Details and patient eligibility

About

The goal of this study is to evaluate a digital chronic disease self-management program designed to provide virtual support and guidance for patients with type 2 diabetes.

Full description

Approximately 45% of patients with type 2 diabetes do not achieve adequate glycemic control (A1C < 7%). When diabetes is uncontrolled, complications develop that threaten health and endanger life. This study will make an effort to address this growing health challenge and to reduce the burden of diabetes in this population. More broadly, this study will have important implications and benefits for the growing diabetes population in the U.S. Study results will inform future interventions to reduce diabetes and improve outcomes. A better understanding of the efficacy of a digital chronic disease self-management program will directly benefit the participants of the program but, in the future, has the potential to more broadly benefit this population throughout the nation.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults at least 18 years of age and less than 65 years of age
• Overweight (BMI ≥ 25 kg/m2, or BMI ≥ 23 kg/m2 if of Asian descent)
• Uncontrolled type 2 diabetes (HbA1C ≥7.5% and ≤12%)
• Diagnosed with type 2 diabetes at least 6 months ago, but not more than 10 years ago
• Has a compatible smartphone running either Android Operating System 5.0 or higher, or iPhone 7 or later, running iOS 11 or higher.
• Willing to set up an online account
• An email address in regular use
• Ambulatory (e.g., living at home and not in a skilled nursing facility)
• Able to speak, understand, and read English

Exclusion criteria

• A diagnosis of Type 1 diabetes
• Currently pregnant or postpartum (within 4 weeks)
• Currently using a continuous glucose monitor to manage diabetes
• Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
• Skin lesions, scarring, redness, infection or edema at the continuous glucose monitor application sites (upper arm) that could interfere with sensor placement or the accuracy of interstitial glucose measurements
• An active eating disorder such as anorexia or bulimia (not including binge-eating disorder) for which he/she has received treatment in the past 12 months
• Alcohol or substance abuse that impairs ability to participate in the program
• Unable to engage in physical activity for more than 2 months over the next 6 months (i.e. due to injury or recent or planned surgery)
• Any of the following in the past 3 months AND are not medically cleared by your physician to exercise: Transient ischemic attack or stroke; Heart attack (myocardial infarction); Hospitalization for congestive heart failure; Cardiac surgery (such as coronary artery bypass grafting (CABG), coronary artery stenting); Bariatric/gastric bypass surgery
• Received a solid Organ Transplant (kidney, liver, etc.) within the past 6 months
• Recent (within the last 6 months) or planned cancer treatment (chemotherapy, radiation, bone marrow transplant, cancer-related surgery - not including hormonal chemotherapy, such as tamoxifen).
• On dialysis treatment
• Taking steroids or prednisone (high doses) or getting cortisone injection
• Stage 4-5 Chronic Kidney Disease
• Class 3-4 Congestive Heart Failure
• Participation in diabetes education in the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Online Diabetes Self-Management Education and Support (DSMES) Program

Experimental group

Description:

Participants will receive access to a 6-month online DSMES program that includes several components that are standard to DSMES. Participants receive online curriculum, access to a live Certified Diabetes Care and Education Specialist (CDCES), interactive group message forums, and connected devices for monitoring food intake, weight, physical activity and glucose levels.

Treatment:

Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program

Matched Control

No Intervention group

Description:

A de-identified dataset of control subjects matched on baseline demographics and clinical characteristics will be cultivated for comparison to the active intervention arm.