Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

Scripps Whittier Diabetes Institute

Status: Enrolling

Conditions: Diabetes Type 2

Treatments: Other: Dulce Digital Text Messaging Intervention; Other: CGM Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06296550

Dulce Digital CGM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

CGM Group

Experimental group

Description:

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).

Treatment:

Other: CGM Device

Other: Dulce Digital Text Messaging Intervention

Usual Care Blood Glucose Monitoring Group

Other group

Description:

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

Treatment:

Other: Dulce Digital Text Messaging Intervention