Status:
TERMINATED
Impact of a Digital Self-Management Program on A1C for Individuals With Type 2 Diabetes
Lead Sponsor:
Omada Health, Inc.
Collaborating Sponsors:
Sutter Health
Palo Alto Medical Foundation
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04892680
Start Date
March 4 2021
End Date
August 2 2021
Last Update
May 11 2022
Active Locations (1)
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1
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301