Type 2 DiabetesNCT04892680
Impact of a Digital Self-Management Program on A1C for Individuals With Type 2 Diabetes
A study testing Online Diabetes Self-Management Education and Support (DSMES) Program in people with Type 2 Diabetes, run by Omada Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Online Diabetes Self-Management Education and Support (DSMES) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
About this study
Official title: Enhancing Cardiometabolic Care Study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Online Diabetes Self-Management Education and Support (DSMES) Program
- Keywords
- type 2 diabetes, diabetes education, digital health, behavior modification
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Diabetes Self-Management Education and Support (DSMES) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c at 6 months from baseline
Non-fasting venous blood sample
Measured: Baseline, 6 months
Secondary outcomes (2)
Change in weight at 6 months from baseline
Percentage of body weight loss
Measured: Baseline, 6 months
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
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start4 Mar 2021
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Why it stopped: Study terminated prematurely due to operational futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omada Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sutter Health, Palo Alto Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Jiang Li, PhD, Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892680
- Sponsor's protocol ID
- 2020.082-1
- Status last verified
- May 2022
- First submitted
- 4 May 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cardiometabolic Care Study
- ClinicalTrials.gov ID
- NCT04892680
- Acronym / sponsor ID
- 2020.082-1
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, diabetes education, digital health, behavior modification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to operational futility.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Omada Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sutter Health, Palo Alto Medical Foundation
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Diabetes Self-Management Education and Support (DSMES) Program | Experimental | Behavioral: Online Diabetes Self-Management Education and Support (DSMES) ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Diabetes Self-Management Education and Support (DSMES) ProgramDigital 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. | Behavioural | Online Diabetes Self-Management Education and Support (DSMES) Program |
Primary outcome
Change in HbA1c at 6 months from baseline
Time frame: Baseline, 6 months
Non-fasting venous blood sample
2 secondary outcomes
Change in weight at 6 months from baseline
Time frame: Baseline, 6 months
Change in medication adherence at 6 months from baseline
Time frame: Baseline, 6 months
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to operational futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Li, PhD principal investigator
Palo Alto Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Diabetes Self-Management Education and Support (DSMES) Program in people with Type 2 Diabetes, run by Omada Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated prematurely due to operational futility.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c at 6 months from baseline (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.