Clinical trial NCT04892680: Impact of a Digital Self-Management Program on A1C for Individuals With Type 2 Diabetes
Official title: Enhancing Cardiometabolic Care Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
diabetes education
digital health
behavior modification
Lead sponsor: Omada Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sutter Health
name: Palo Alto Medical Foundation
First posted: 2021-05-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c at 6 months from baseline
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in weight at 6 months from baseline
timeFrame: Baseline, 6 months
measure: Change in medication adherence at 6 months from baseline
timeFrame: Baseline, 6 months
Other outcomes:
measure: Health care utilization at 6 and 12 months from baseline
timeFrame: Baseline, 6 months, 12 months
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Jiang Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: