Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

NCT ID: NCT06296550

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2027-04-30

Brief Summary

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.

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, the investigators 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 the understanding of the potential advantages and informing future diabetes care practices.

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Dulce Digital Text Messaging Intervention

Intervention Type: OTHER

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 them to test their blood sugar and text back blood sugar reading.

CGM Device

Intervention Type: OTHER

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 instructions on using continuous glucose monitors.

Usual Care Blood Glucose Monitoring Group

Participants will use standard blood glucose monitoring devices that are covered by health insurance.

Group Type: OTHER

Dulce Digital Text Messaging Intervention

Intervention Type: OTHER

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 them to test their blood sugar and text back blood sugar reading.

Interventions

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 them to test their blood sugar and text back blood sugar reading.

Intervention Type: 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 instructions on using continuous glucose monitors.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with type 2 diabetes
• Are not currently using a CGM
• Are not using insulin therapies
• Speak English, Spanish or Arabic
• Have A1c between 7.5% and 12.0% in last 90 days
• Have a cellphone that can receive/send text messages and counts steps

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

Scripps Whittier Diabetes Institute

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kallie Brown, PhD

Role: CONTACT

brown.kallie@scrippshealth.org

858-258-3555

Athena Philis-Tsimikas, MD

Role: CONTACT

philis-Tsimikas.athena@scrippshealth.org

877-944-8843

Facility Contacts

Athena Philis-Tsimikas, MD

Role: primary

tsimikas.athena@scrippshealth.org

877-944-8843

Kallie Brown, PhD

Role: backup

brown.kallie@scrippshealth.org

858-258-3555

Other Identifiers

Dulce Digital CGM

Identifier Type: -

Identifier Source: org_study_id