Type 2 Diabetes Clinical Trial
Official title:
Enhancing Cardiometabolic Care Study
Verified date | May 2022 |
Source | Omada Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | August 2, 2021 |
Est. primary completion date | August 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Palo Alto Medical Foundation Research Institute | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Omada Health, Inc. | Palo Alto Medical Foundation, Sutter Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | Change in HbA1c at 6 months from baseline | Non-fasting venous blood sample | Baseline, 6 months | |
Secondary | Change in weight at 6 months from baseline | Percentage of body weight loss | Baseline, 6 months | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |