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

NCT05368454 | Completed

• 1 other identifier: 2022 V 5.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Non-fasting venous blood sample

  Baseline, 3 months, 6 months

Secondary Outcomes (4)

• Change in daily Time in Range [70-180] mg/dL

  Baseline, 3 months, 6 months

• Change in body weight

  Baseline, 3 months, 6 months

• Change in resting blood pressure

  Baseline, 3 months, 6 months

• Change in diabetes distress

  Baseline, 3 months, 6 months

Study Arms (2)

Integrated Solution

EXPERIMENTAL

Behavioral: Online Diabetes Self-Management Education and Support (DSMES) Program

Standard of Care

ACTIVE COMPARATOR

Behavioral: Standard of Care

Interventions

Online Diabetes Self-Management Education and Support (DSMES) Program BEHAVIORAL

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.

Integrated Solution

Standard of Care BEHAVIORAL

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Omada Health, Inc.: lead
• Abbott Diabetes Care: collaborator
• Evidation Health: collaborator

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care; Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah Linke, PhD

  Omada Health, Inc.

  STUDY DIRECTOR

• David Kerr, MBChB, DM, FRCPE

  Evidation Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: May 31, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)