140 Participants Needed

CGM and Digital Education for Type 2 Diabetes

AP
KB
KB
Overseen ByKallie Brown, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scripps Whittier Diabetes Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be using insulin therapies.

Is the CGM and Digital Education treatment safe for humans?

The text messaging interventions for diabetes management, like Dulce Digital, have been used safely in studies with no reported safety concerns, suggesting they are generally safe for humans.12345

How does the Dulce Digital Text Messaging Intervention treatment differ from other treatments for type 2 diabetes?

The Dulce Digital Text Messaging Intervention is unique because it uses text messages to provide personalized education and support for managing type 2 diabetes, which is a low-cost and accessible method compared to traditional in-person consultations. This approach leverages the widespread use of mobile phones to deliver instant reminders and motivational messages, helping patients improve their diabetes self-management and outcomes.26789

What data supports the effectiveness of the treatment CGM Device, Dulce Digital Text Messaging Intervention for Type 2 Diabetes?

Research shows that personalized text messages can improve diabetes knowledge, self-care, and blood sugar control in people with type 2 diabetes. In one study, participants who received educational and motivational text messages saw significant improvements in their blood sugar levels and self-management skills.210111213

Who Is on the Research Team?

Dr. Athena Philis-Tsimikas ...

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Health

Are You a Good Fit for This Trial?

This trial is for patients with type 2 diabetes who do not use insulin. It's designed to see if adding a continuous glucose monitoring (CGM) device to a text messaging education program can help manage their condition over six months.

Inclusion Criteria

HbA1c 7.5% to greater than or equal to 12.0%
I am taking diabetes medication that is not insulin.
I have a mobile phone that can receive texts and count steps.
See 1 more

Exclusion Criteria

Are pregnant
Are currently participating in another CGM-related study
I am currently using insulin for my diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous glucose monitoring devices and participate in a text messaging diabetes education program

6 months
18 device replacements (every 10 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CGM Device
  • Dulce Digital Text Messaging Intervention
Trial Overview The study tests whether the Dulce Digital Text Messaging Intervention, when combined with real-time CGM devices, improves diabetes management in non-insulin using type 2 diabetes patients compared to just the educational texts alone.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Usual Care Blood Glucose Monitoring GroupExperimental Treatment1 Intervention
Participants will use standard blood glucose monitoring devices that are covered by health insurance.
Group II: CGM GroupExperimental Treatment2 Interventions
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials
19
Recruited
5,400+

Published Research Related to This Trial

A meta-analysis of 10 studies involving 380 interventions showed that distance education and SMS reminders significantly reduced HbA1c levels in type-2 diabetes patients, with an overall effect size of -0.49%.
The same interventions also improved medication adherence, with a strong effect size of 0.96, indicating that texting reminders can be an effective strategy for managing diabetes over the first 6 months.
Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies.Zhuang, Q., Chen, F., Wang, T.[2022]
The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including reductions in HbA1c, body weight, blood pressure, and cholesterol levels over an average follow-up of 8 months in 100 patients.
Compared to a control group, the ProEmpower participants showed significantly better improvements in cardiovascular risk factors, highlighting the efficacy of digital technologies in enhancing diabetes management and promoting healthier lifestyles.
Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus.De Luca, V., Bozzetto, L., Giglio, C., et al.[2023]
A study involving 414 low-income Hispanic adults with poorly managed type 2 diabetes is evaluating the effectiveness of three different mobile health interventions over 12 months, including personalized text messaging and telephonic support, to improve diabetes management and clinical outcomes.
The trial aims to determine how these mobile technology approaches can enhance patient-provider communication, medication adherence, and overall diabetes control, potentially reducing health disparities in the Hispanic population.
Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes.Philis-Tsimikas, A., Fortmann, AL., Godino, JG., et al.[2023]

Citations

Text Message Intervention for Latino Adults to Improve Diabetes Outcomes. [2022]
Effectiveness of mobile phone text messaging in improving glycaemic control among persons with newly detected type 2 diabetes. [2020]
Digital interventions self-management education for type 1 and 2 diabetes: A systematic review and meta-analysis. [2022]
Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies. [2022]
Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. [2023]
Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. [2023]
Does Diabetes Distress Influence Clinical Response to an mHealth Diabetes Self-Management Education and Support Intervention? [2022]
Evaluating the Impact of Mobile Phone Technology on Health Outcomes for Latinos with Type 2 Diabetes. [2021]
Mobile phone text messaging in the management of diabetes. [2022]
A pilot test of the Self-Management and Research Technology project: A text message-based diabetes self-management program for adolescents. [2019]
Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Computerized Automated Reminder Diabetes System (CARDS): e-mail and SMS cell phone text messaging reminders to support diabetes management. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Feasibility of the SMART Project: A Text Message Program for Adolescents With Type 1 Diabetes. [2020]
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