Enhancing Digitally Delivered Diabetes Education With Real-Time CGM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dulce Digital Text Messaging Intervention, CGM Device.
- Who it may be relevant to
- Registry conditions: Diabetes Type 2. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- HbA1c [Time frame: 6 months]
Secondary outcome measures (5)
- CGM Metric Time in Range [Time frame: 6 months]
- CGM Metric Time above Range [Time frame: 6 months]
- CGM Metric Time Below Range [Time frame: 6 months]
- Summary of Diabetes Self Care Activities (SDSCA) Survey [Time frame: 6 months]
- Diabetes Distress Scale [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Scripps Whittier Diabetes Institute — San Diego
Identifiers
NCT: NCT06296550 · Dulce Digital CGM