Clinical trial NCT06296550: Enhancing Digitally Delivered Diabetes Education With Real-Time CGM
Official title: Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes
CGM
Diabetes Education
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: CGM Metric Time in Range
timeFrame: 6 months
measure: CGM Metric Time above Range
timeFrame: 6 months
measure: CGM Metric Time Below Range
timeFrame: 6 months
measure: Summary of Diabetes Self Care Activities (SDSCA) Survey
timeFrame: 6 months
measure: Diabetes Distress Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Health
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References: