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

NCT04892680 | Terminated

• 1 other identifier: 2020.082-1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; diabetes education; digital health; behavior modification

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c at 6 months from baseline

  Non-fasting venous blood sample

  Baseline, 6 months

Secondary Outcomes (2)

• Change in weight at 6 months from baseline

  Baseline, 6 months

• Change in medication adherence at 6 months from baseline

  Baseline, 6 months

Other Outcomes (1)

• Health care utilization at 6 and 12 months from baseline

  Baseline, 6 months, 12 months

Study Arms (2)

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

EXPERIMENTAL

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

Matched Control

NO INTERVENTION

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omada Health, Inc.: lead
• Sutter Health: collaborator
• Palo Alto Medical Foundation: collaborator

Study Sites (1)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jiang Li, PhD

  Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 19, 2021
• Study Start: March 4, 2021
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)