CGM and Digital Education for Type 2 Diabetes

Overseen By Kallie Brown, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Whittier Diabetes Institute

Must not be taking: Insulin

Disqualifiers: Pregnancy, Other diabetes study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 6 months

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining continuous glucose monitors (CGMs) with the Dulce Digital Text Messaging Intervention can improve type 2 diabetes management for those not using insulin. Participants will either use a CGM or continue with standard blood glucose monitoring. It suits individuals diagnosed with type 2 diabetes who are not yet using insulin or CGMs and have an A1c between 7.5% and 12.0%. English, Spanish, or Arabic speakers with a phone capable of texting and step counting may qualify. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management strategies.

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.

What prior data suggests that the CGM device is safe for monitoring blood glucose in patients with type 2 diabetes?

Research has shown that the Dexcom G7 continuous glucose monitor (CGM) is generally safe to use. Studies have found no serious side effects associated with its use. The device provides accurate blood sugar readings, aiding in effective diabetes management. However, the CGM might not function correctly if acetaminophen, a common pain reliever, has been taken recently. Some issues with the device's app, related to software updates, could cause problems if not addressed, but these are rare. Overall, the Dexcom G7 is safe and well-tolerated for most people with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of continuous glucose monitors (CGMs) and a digital text messaging intervention to manage Type 2 Diabetes. Unlike traditional methods that rely on standard blood glucose monitoring devices, CGMs like the Dexcom G7 provide real-time, continuous insights into blood sugar levels, potentially leading to more precise and timely adjustments in treatment. Additionally, the Dulce Digital Text Messaging Intervention aims to educate and support patients through personalized messages, which could enhance patient engagement and adherence to treatment plans. This combination of advanced monitoring and digital education could offer a more proactive and personalized approach to diabetes management.

What evidence suggests that the CGM device and digital education intervention could be effective for type 2 diabetes?

Research has shown that continuous glucose monitors (CGMs), such as the Dexcom G7 provided to participants in the CGM Group of this trial, can significantly aid in managing type 2 diabetes. In previous studies, individuals using these devices saw their A1C levels, a measure of average blood sugar, drop by about 2.4% over six months, indicating improved blood sugar control. Another study found that severe low blood sugar events decreased from 14.6% to 7.8% with CGM use. These findings suggest that CGMs can effectively help people with type 2 diabetes manage their condition better. ^{2 6 7 8 9}

Who Is on the Research Team?

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.

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?

Group I: Usual Care Blood Glucose Monitoring Group Experimental Treatment 1 Intervention

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

Group II: CGM Group Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The SMS4BG intervention, a tailored text message support program for diabetes management, was found to be highly acceptable and useful among participants, with 93% reporting positive experiences after a 3-month pilot study involving 42 adults with poorly controlled diabetes.

Participants experienced a significant decrease in HbA1c levels, indicating improved glycemic control, suggesting that SMS4BG may effectively support diabetes self-management, although further research through a randomized controlled trial is needed to confirm its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. Dobson, R., Carter, K., Cutfield, R., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot study involving 40 insulin-treated adolescents and young adults, cell phone text messaging significantly increased the frequency of blood glucose monitoring compared to e-mail reminders, with participants receiving an average of 180.4 reminders versus 106.6.

While text messaging proved to be an effective method for engaging users initially, maintaining consistent usage over the 3-month period was challenging, indicating a need for strategies to sustain interest in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Automated Reminder Diabetes System (CARDS): e-mail and SMS cell phone text messaging reminders to support diabetes management. Hanauer, DA., Wentzell, K., Laffel, N., et al.[2022]

A Spanish-language text messaging program significantly improved diabetes management in Latinos, resulting in a median HbA1c reduction of 1.4 percentage points after 3 months among 38 participants.

Participants with higher initial HbA1c levels (over 10.0%) experienced even greater reductions (3.8 percentage points), indicating that this intervention may be particularly beneficial for those with more severe diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Mobile Phone Technology on Health Outcomes for Latinos with Type 2 Diabetes. Jackson, LV., Carpenter, DM., Postlethwaite, DA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9208857/

Accuracy and Safety of Dexcom G7 Continuous Glucose ... We evaluated the accuracy and safety of a seventh generation (G7) Dexcom continuous glucose monitor (CGM) during 10.5 days of use in adults with diabetes.

2. provider.dexcom.com provider.dexcom.com/dexcom-community-glucose-monitoring-project-six-month-results-using-continuous-glucose-monitoring

Six-Month Results Using Continuous Glucose Monitoring ... Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

3. diabetesjournals.org diabetesjournals.org/clinical/article/42/4/540/157065/The-Dexcom-Community-Glucose-Monitoring-Project-6

The Dexcom Community Glucose Monitoring Project: 6-Month ... After 6 months of program participation, mean A1C decreased by 2.4 ± 1.9% from baseline to 6-month follow-up (from 9.4 ± 1.7 to 7.1 ± 1.2%, P <0.001).

4. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/view-compare-cgms/product-detail/dexcom-g7

Dexcom G7 The G7 features enhanced alert settings, a redesigned mobile app, and a Direct to Apple Watch capability. This allows CGM data to be sent directly to the watch ...

5. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Another study indicates that severe hypoglycemia incidence decreased from 14.6% to 7.8% after CGM adoption [19]. Effectiveness of CGM in ...

6. dexcom.com dexcom.com/en-is/safety-information

Safety Information Do not rely on continuous glucose monitoring (CGM) data produced by the Dexcom G5 Mobile CGM System if you have recently taken paracetamol/acetaminophen.

7. fda.gov fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitor-apps-correction-dexcom-inc-issues-correction-g7-apps-and-one-apps-due

Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps This device may cause serious injury or death if you continue to use it without correction. Affected Product. Product Names: Dexcom G7 ...

8. dexcom.com dexcom.com/en-us/g7-cgm-system

Dexcom G7 CGM - Powerfully Simple Diabetes Management Dexcom G7 is the most accurate CGM for type 1 or type 2 diabetes, a connected device to easily manage your diabetes with confidence and improve your health.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35157505/

Accuracy and Safety of Dexcom G7 Continuous Glucose ... No serious adverse events were reported. Conclusions: The G7 CGM provides accurate glucose readings with single-digit MARD with arm or abdomen placement in ...