search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Diabetes Self-Management Education and Support (DSMES) Program
Sponsored by
Omada Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, diabetes education, digital health, behavior modification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Palo Alto Medical Foundation Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Matched Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in HbA1c at 6 months from baseline
Non-fasting venous blood sample

Secondary Outcome Measures

Change in weight at 6 months from baseline
Percentage of body weight loss
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

Full Information

First Posted
May 4, 2021
Last Updated
May 5, 2022
Sponsor
Omada Health, Inc.
Collaborators
Sutter Health, Palo Alto Medical Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04892680
Brief Title
Impact of a Digital Self-Management Program on A1C for Individuals With Type 2 Diabetes
Official Title
Enhancing Cardiometabolic Care Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study terminated prematurely due to operational futility.
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
August 2, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omada Health, Inc.
Collaborators
Sutter Health, Palo Alto Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, diabetes education, digital health, behavior modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Diabetes Self-Management Education and Support (DSMES) Program
Arm Type
Experimental
Arm 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.
Arm Title
Matched Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Online Diabetes Self-Management Education and Support (DSMES) Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c at 6 months from baseline
Description
Non-fasting venous blood sample
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in weight at 6 months from baseline
Description
Percentage of body weight loss
Time Frame
Baseline, 6 months
Title
Change in medication adherence at 6 months from baseline
Description
The Adherence Estimator, a three-item self-report questionnaire, will be used to assess medication adherence
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Health care utilization at 6 and 12 months from baseline
Description
Patient electronic health record data will be collected to examine the impact on short-term health care utilization
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Li, PhD
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation Research Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs