Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296550
• Other study ID #: Dulce Digital CGM
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: Scripps Whittier Diabetes Institute
• Contact: Kallie Brown, MA
• Phone: 858-678-6294
• Email: brown.kallie[@]scrippshealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with type 2 diabetes

• Are on non-insulin 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Scripps Whittier Diabetes Institute	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Measures participants A1c using lab results provided from healthcare provider.	6 months
Secondary	CGM Metric Time in Range	Measures the percentage of time a participant's blood glucose levels stay within the target range using CGM device.	6 months
Secondary	CGM Metric Time above Range	Measures the percentage of time a participant's blood glucose levels exceed the target range using CGM device.	6 months
Secondary	CGM Metric Time Below Range	Measures the percentage of time a participant's blood glucose levels fall below the target range using CGM device.	6 months
Secondary	Summary of Diabetes Self Care Activities (SDSCA) Survey	Summary of Diabetes Self Care Activities Survey measures frequency and consistency of diabetes self-care activities during the past 7 days. Possible scores range from 0 (0 Days to 7 (7 Days). Higher scores indicate better compliance with diabetes self-care.	6 months
Secondary	Diabetes Distress Scale	The Diabetes Distress Scale measures four critical dimensions of diabetes distress for participants: emotional, burden, regimen distress, interpersonal distress and physical distress. Possible scores range from 1 (Not a Problem) to 6 (A Very Serious Problem) with higher scores indicating higher levels of diabetes-related distress.	6 months