Evaluation of a Digital Diabetes Self-Management Education and Support Program

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT05368454

Run by

Omada Health, Inc.

People needed

100

Starts

2022-05-31

Expected to finish

2024-01-24

Last updated by the study team

2024-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.
• a. 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

You may not qualify if…

• 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
• 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

Where it is running

• Evidation Health — San Mateo, California, United States

Full record on ClinicalTrials.gov

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