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

Enhancing Cardiometabolic Care Study

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Diabetes Self-Management Education and Support (DSMES) Program; 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.	Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program; Digital delivery of a DSMES program designed to build self-management skills and support diabetes management. Recipients have access to online curriculum, a live CDCES, group-based communication forums, and connected technology to track weight, food intake, physical activity and glucose levels.
No Intervention: Matched Control; A de-identified dataset of control subjects matched on baseline demographics and clinical characteristics will be cultivated for comparison to the active intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c at 6 months from baseline	Non-fasting venous blood sample	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight at 6 months from baseline	Percentage of body weight loss	Baseline, 6 months
Change in medication adherence at 6 months from baseline	The Adherence Estimator, a three-item self-report questionnaire, will be used to assess medication adherence	Baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization at 6 and 12 months from baseline	Patient electronic health record data will be collected to examine the impact on short-term health care utilization	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Omada Health, Inc.
• Collaborators: Palo Alto Medical Foundation; Sutter Health
• Investigators: Principal Investigator: Jiang Li, PhD, Palo Alto Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): August 2, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: type 2 diabetes; digital health; behavior modification; diabetes education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2020.082-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No