Type 2 DiabetesNCT05368454
Evaluation of a Digital Diabetes Self-Management Education and Support Program
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 examine the efficacy of an integrated solution, defined as a combination of the Abbott FreeStyle Libre 14-day CGM sensor and the Omada care team's receipt of real-time, continuous glucose data from the sensor and incorporation of this data into their care delivery within the context of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 24 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Lives in the United States and has a valid mailing address
- Speaks, reads, and understands English as the primary language
- Be willing and able to provide written, signed, and dated informed consent
- Has a self-reported diagnosis of type 2 diabetes prior to enrollment for at least 6 months
- Self-reports HbA1c value ≥8.0% from most recent test taken within the past 6 months
Show all 15Show fewer
- Treatment regimen includes diet and exercise alone, oral glucose lowering medication, non-insulin injectable medications, basal insulin and/or combination of basal insulin plus oral medications. No more than 15% of the total sample may be on combination basal insulin/oral medication.
- If the regimen is basal insulin with oral medications, the participant must have initiated basal insulin in addition to oral medication at least 6 months prior to enrollment.
- Currently on medication regimen for at least 3 months prior to enrollment
- HbA1c greater than or equal to 8.0% as demonstrated by laboratory HbA1c at secondary screening
- Has a compatible smartphone running either Android OS 5.0 or higher, or iPhone 7 or later, running iOS 11 or higher with an on-going data plan
- Is willing to set up an online account using the Omada Health Program/app and LibreLink app, and agree to share their CGM data with designated health care providers connected to the study.
- Must be willing to complete all study tasks as specified by the protocol
- Must report being compliant with their diabetes management plan and must be willing to adhere to their medication regimen throughout the study.
- Not currently in another clinical trial
Who cannot join
- Type 1 diabetes or a history of diabetic ketoacidosis
- Self-reported HbA1c < 8.0% or does not know their HbA1c level
- Self-reported condition leading to life expectancy < 12 months
- Pregnant, is attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to female participants who are able to become pregnant only)
- Currently has self-reported skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. This includes known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Has X-ray, MRI or CT appointment scheduled during the study periods of CGM measurement with the FreeStyle Libre Pro, and the appointment(s) cannot be rescheduled
Show all 20Show fewer
- Currently using mealtime bolus injections of insulin, premixed insulin formulations or a continuous subcutaneous infusion of insulin
- Visual impairment that would prohibit ability to view sensor data or use the Omada platform
- Has had any of the following in the past 3 months:
- 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)
- If it has been > 3 months since any of the above, applicant must be medically cleared by their primary physician to exercise
- Bariatric/gastric bypass surgery, including gastric sleeve, gastric balloon within the past 6 months
- Participation in other research studies involving medication or device within 1 month prior to enrollment
- 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)
- Self-reported renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m2
- Language barriers precluding comprehension of study activities and informed consent 16. Currently on a routine regimen of glucocorticoids or psychotropic medications 17. Self-reported alcohol or substance abuse issue or dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of an Integrated Lifestyle Management Solution With Continuous Glucose Monitoring for Type 2 Diabetes
The goal of this study is to examine the efficacy of an integrated solution, defined as a combination of the Abbott FreeStyle Libre 14-day CGM sensor and the Omada care team's receipt of real-time, continuous glucose data from the sensor and incorporation of this data into their care delivery within the context of the Omada for Diabetes program for adults with Type 2 Diabetes (T2D). This randomized control trial will test the impact of the integrated solution on HbA1c, CGM-derived metrics and other relevant diabetes management outcomes over six months compared to the current standard of care.
Read the detailed description
Type 2 diabetes (T2D) contributes substantially to morbidity and mortality in the US. Lifestyle management is a fundamental component of care for T2D. This includes self-management education and support, medical nutrition therapy, physical activity, smoking cessation counseling, and psychosocial care for the person with diabetes. Diabetes self-management education and support (DSMES) specifically pertains to helping people acquire the knowledge, skills, and ability for diabetes self-care, and assisting people to engage in the health-related behaviors needed to manage this condition on an ongoing basis. Research has shown that DSMES programs that target behavioral changes with intensive counseling and support lead to improved glucose control.
In recent years, technology-enabled platforms have been developed to deliver self-management support and education virtually, and commercial products are common. These platforms allow people with chronic diseases to access self-management support and education through their personal mobile devices (e.g., smartphones, tablets, laptops) and eliminate the need to travel to physical facilities for diabetes education sessions. The increased convenience brings potential to increase access, availability, and acceptability.
The development of Continuous Glucose Monitoring (CGM) has further advanced care and management of T2D. In particular, real-time CGM allows the person to view real-time glucose readings and patterns over time, without the need for painful finger sticks. While the majority of studies of CGM have been conducted with people with T2Ds using insulin, some clinical trials have shown that the use of real-time CGM is associated with improvements in glycemic control in people with T2D not using insulin.
The current standards of care for diabetes recommend CGM use for people with Type 1 and 2 diabetes when it is coupled with "robust diabetes education, training and support". However, there is a lack of well-integrated solutions that combine the potential benefit of both digitally delivered DSMES and CGM in a seamless way. Therefore, the purpose of this study is to examine the efficacy of a novel integrated solution of a digitally delivered T2D self-management education and support program with a continuous glucose monitor (CGM) built into the digital platform. The randomized control trial will test the impact of the novel solution for improving HbA1c and related CGM-derived outcomes and relevant diabetes management outcomes over six months related to the current standard of care.
- Conditions
- Type 2 Diabetes
- Being tested
- Online Diabetes Self-Management Education and Support (DSMES) Program, Standard of Care
- 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
An online program for Diabetes Self-Management, Education and Support (DSMES) that includes personal coaching by a certified Diabetes Care and Education Specialist (CDCES), tracking tools, and FreeStyle Libre CGMs, a wearable sensor with data scanning ability accessed through the smartphone app.
Standard of CareBehavioural
All participants randomized to the standard of care/control arm will be asked to continue with their current care plan and care team for management of their diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Solution | Experimental | Not described Receives: Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Non-fasting venous blood sample
Measured: Baseline, 3 months, 6 months
Secondary outcomes (4)
Change in daily Time in Range [70-180] mg/dL
Derived from continuous glucose monitor
Measured: Baseline, 3 months, 6 months
Change in body weight
Measured with a digital weight scale in stocking feet
Measured: Baseline, 3 months, 6 months
Change in resting blood pressure
Collected with an automated, calibrated blood pressure monitor with self-inflating cuff
Measured: Baseline, 3 months, 6 months
Change in diabetes distress
The Diabetes Distress Scale, a 17-item self-report questionnaire, that captures four dimensions: emotional burden, regimen distress, interpersonal distress and physician distress related to diabetes and diabetes self-care
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start31 May 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omada Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Diabetes Care, Evidation Health
- Responsible party
- Sponsor
- Investigators
- Sarah Linke, PhD, Study director, Omada Health, Inc.David Kerr, MBChB, DM, FRCPE, Principal investigator, Evidation Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368454
- Sponsor's protocol ID
- 2022 V 5.0
- Status last verified
- Apr 2024
- First submitted
- 5 May 2022
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of an Integrated Lifestyle Management Solution With Continuous Glucose Monitoring for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05368454
- Acronym / sponsor ID
- 2022 V 5.0
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Omada Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Abbott Diabetes Care, Evidation Health
- Study start
- 31 May 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 10 May 2022 (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 examine the efficacy of an integrated solution, defined as a combination of the Abbott FreeStyle Libre 14-day CGM sensor and the Omada care team's receipt of real-time, continuous glucose data from the sensor and incorporation of this data into their care delivery within the context of the Omada for Diabetes program for adults with Type 2 Diabetes (T2D). This randomized control trial will test the impact of the integrated solution on HbA1c, CGM-derived metrics and other relevant diabetes management outcomes over six months compared to the current standard of care.
Detailed description
Type 2 diabetes (T2D) contributes substantially to morbidity and mortality in the US. Lifestyle management is a fundamental component of care for T2D. This includes self-management education and support, medical nutrition therapy, physical activity, smoking cessation counseling, and psychosocial care for the person with diabetes. Diabetes self-management education and support (DSMES) specifically pertains to helping people acquire the knowledge, skills, and ability for diabetes self-care, and assisting people to engage in the health-related behaviors needed to manage this condition on an ongoing basis. Research has shown that DSMES programs that target behavioral changes with intensive counseling and support lead to improved glucose control.
In recent years, technology-enabled platforms have been developed to deliver self-management support and education virtually, and commercial products are common. These platforms allow people with chronic diseases to access self-management support and education through their personal mobile devices (e.g., smartphones, tablets, laptops) and eliminate the need to travel to physical facilities for diabetes education sessions. The increased convenience brings potential to increase access, availability, and acceptability.
The development of Continuous Glucose Monitoring (CGM) has further advanced care and management of T2D. In particular, real-time CGM allows the person to view real-time glucose readings and patterns over time, without the need for painful finger sticks. While the majority of studies of CGM have been conducted with people with T2Ds using insulin, some clinical trials have shown that the use of real-time CGM is associated with improvements in glycemic control in people with T2D not using insulin.
The current standards of care for diabetes recommend CGM use for people with Type 1 and 2 diabetes when it is coupled with "robust diabetes education, training and support". However, there is a lack of well-integrated solutions that combine the potential benefit of both digitally delivered DSMES and CGM in a seamless way. Therefore, the purpose of this study is to examine the efficacy of a novel integrated solution of a digitally delivered T2D self-management education and support program with a continuous glucose monitor (CGM) built into the digital platform. The randomized control trial will test the impact of the novel solution for improving HbA1c and related CGM-derived outcomes and relevant diabetes management outcomes over six months related to the current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Solution | Experimental | Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 years or older
- Lives in the United States and has a valid mailing address
- Speaks, reads, and understands English as the primary language
- Be willing and able to provide written, signed, and dated informed consent
- Has a self-reported diagnosis of type 2 diabetes prior to enrollment for at least 6 months
Key exclusion criteria (20 listed)
- Type 1 diabetes or a history of diabetic ketoacidosis
- Self-reported HbA1c < 8.0% or does not know their HbA1c level
- Self-reported condition leading to life expectancy < 12 months
- Pregnant, is attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to female participants who are able to become pregnant only)
- Currently has self-reported skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. This includes known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
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) ProgramAn online program for Diabetes Self-Management, Education and Support (DSMES) that includes personal coaching by a certified Diabetes Care and Education Specialist (CDCES), tracking tools, and FreeStyle Libre CGMs, a wearable sensor with data scanning ability accessed through the smartphone app. | Behavioural | Integrated Solution |
| Standard of CareAll participants randomized to the standard of care/control arm will be asked to continue with their current care plan and care team for management of their diabetes. | Behavioural | Standard of Care |
Primary outcome
Change in HbA1c
Time frame: Baseline, 3 months, 6 months
Non-fasting venous blood sample
4 secondary outcomes
Change in daily Time in Range [70-180] mg/dL
Time frame: Baseline, 3 months, 6 months
Change in body weight
Time frame: Baseline, 3 months, 6 months
Change in resting blood pressure
Time frame: Baseline, 3 months, 6 months
Change in diabetes distress
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Sarah Linke, PhD study director
Omada Health, Inc.
David Kerr, MBChB, DM, FRCPE principal investigator
Evidation Health
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 15 inclusion and 20 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: finished, as of the sponsor's last update on 10 Apr 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Baseline, 3 months, 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 10 Apr 2024.