Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

February 28, 2024 updated by: Scripps Whittier Diabetes Institute

Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare & Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, we hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Are on non-inuslin therapies
  • HbA1c 7.5% to greater than or equal to 12.0%
  • Access to a mobile phone that accepts texts and counts steps

Exclusion Criteria:

  • Are using insulin therapies
  • Are pregnant
  • Are currently participating in another CGM-related study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM Group
Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months).
Other: Dulce Digital Text Messaging Intervention

Text-based education support program:

  • Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months.
  • Participants will also receive text messages that will ask to test your blood sugar and text back blood sugar reading.
Other: CGM Device
Participants will be provided continuous glucose monitors (Dexcom G7) to actively monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). In addition, participants will attend an information session (group or individual; in-person or virtual) that will provide you with instructions on using continuous glucose monitors.
Other: Usual Care Blood Glucose Monitoring Group
Participants will use standard blood glucose monitoring devices that are covered by health insurance.
Other: Dulce Digital Text Messaging Intervention

Text-based education support program:

  • Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months.
  • Participants will also receive text messages that will ask to test your blood sugar and text back blood sugar reading.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
Measures participants A1c using lab results provided from healthcare provider.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM Metric Time in Range
Time Frame: 6 months
Measures the percentage of time a participant's blood glucose levels stay within the target range using CGM device.
6 months
CGM Metric Time above Range
Time Frame: 6 months
Measures the percentage of time a participant's blood glucose levels exceed the target range using CGM device.
6 months
CGM Metric Time Below Range
Time Frame: 6 months
Measures the percentage of time a participant's blood glucose levels fall below the target range using CGM device.
6 months
Summary of Diabetes Self Care Activitiers (SDSCA) Survey
Time Frame: 6 months
Summary of Diabetes Self Care Activities (SDSCA) Survey
6 months
Diabetes Distress Scale
Time Frame: 6 months
Captures four critical dimensions of diabetes distress for participants: emotional, burden, regimen distress, interpersonal distress and physical distress.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Whittier Diabetes Institute

Investigators

  • Principal Investigator: Athena Philis-Tsimikas, MD, Scripps Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dulce Digital CGM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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