Continuous Glucose Monitoring for Type 2 Diabetes

(CAPAZ-2D Trial)

Overseen By Jessica L McCurley, PhD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Severe mental illness, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how continuous glucose monitors (CGMs) can help young adults better manage type 2 diabetes. Participants will wear a CGM and a FitBit for 30 days to track glucose levels and activity. The study will collect both quantitative data and personal experiences to determine what makes using a CGM easy or difficult and how it affects awareness of glucose patterns. Young adults diagnosed with type 2 diabetes in the last five years who haven't used a CGM before and have a compatible smartphone are ideal candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding diabetes management in young adults.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that continuous glucose monitoring is safe for young adults with type 2 diabetes?

Research has shown that continuous glucose monitors (CGMs) are generally safe for people with type 2 diabetes. Studies have found that using a CGM can reduce episodes of both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). For example, one study found that people using CGMs spent 21% less time with low blood sugar and 23% less time with high blood sugar compared to those who didn’t use them.

Using a CGM is also linked to better blood sugar control, as indicated by lower HbA1c levels, which measure average blood sugar over time. People using CGMs reported feeling healthier and experiencing a better quality of life.

While CGMs are usually well-tolerated, some people might experience skin irritation from the device. However, serious side effects are rare. Overall, CGMs appear to be a safe tool for managing type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using continuous glucose monitors (CGMs) for managing Type 2 diabetes because they offer real-time blood sugar tracking, unlike traditional methods that rely on periodic finger-stick tests. This continuous data allows for better insights into how lifestyle choices affect blood sugar levels, enabling more personalized and immediate adjustments to diet and exercise. By integrating with tools like FitBit activity trackers, CGMs provide a comprehensive view of health behaviors, potentially improving self-management and overall control of diabetes.

What evidence suggests that continuous glucose monitoring is effective for type 2 diabetes?

Research has shown that continuous glucose monitors (CGMs), which participants in this trial will use, can effectively manage type 2 diabetes. Studies have found that using a CGM can lower HbA1c levels, a measure of blood sugar, by about 0.32%. People using CGMs also spend more time with their blood sugar levels in the target range, increasing from about 40% to 62%, which means they spend less time with high blood sugar levels. CGMs help people with type 2 diabetes understand and react to changes in their blood sugar in real-time, supporting better self-management. ^{5 6 7 8 9}

Who Is on the Research Team?

Jessica L McCurley, PhD MPH

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for young adults with type 2 diabetes. Participants will use a continuous glucose monitor (CGM) for 30 days to help manage their condition. The study aims to understand how CGMs can improve self-management of diabetes.

Inclusion Criteria

No prior use or experience with wearable CGMs

I can fluently speak English or Spanish.

Diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record

Exclusion Criteria

Severe mental illness (e.g., psychosis, suicidal ideation)

Pregnancy or less than 6 months postpartum

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a continuous glucose monitor and a FitBit activity tracker for 30 days, completing weekly surveys on diabetes self-management behaviors

4 weeks

Weekly surveys (virtual)

Follow-up

Participants are monitored for changes in diabetes distress, self-management motivation, and physical activity immediately after the intervention

1 week

Qualitative Interviews

Semi-structured qualitative interviews conducted to understand barriers and facilitators of CGM use and preferences for a future CGM-based intervention

Immediately after the intervention

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview The intervention being tested is the use of a continuous glucose monitor by young adults with type 2 diabetes. The study will collect data on how the CGM affects participants' understanding and management of their glucose levels.

How Is the Trial Designed?

Group I: CGM Wear Experimental Treatment 1 Intervention

Participants will wear a continuous glucose monitor for 30 days. They will also wear a FitBit activity tracker watch and complete weekly surveys to report diabetes self-management behaviors.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Scripps Health

Collaborator

Trials

59

Recruited

43,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37987208/

Effectiveness of Continuous Glucose Monitoring on Metrics ... Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%.

2. nature.com nature.com/articles/s41598-024-83548-4

Continuous glucose monitoring among adults with type 2 ... Patients showed improvements in time in range (39.7–61.9%, p < 0.0001), time > 180 mg/dL (60.1–37.9%, p < 0.001), time > 250 mg/dL (27.6–8.5%, p ...

3. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

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

Advances in Continuous Glucose Monitoring: Clinical ... Previous studies have reported HbA1c reductions of 0.25% to 3.0% and TIR increases of 15–34%, alongside a notable decrease in hypoglycemic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X25008985

Effects of Continuous Glucose Monitoring Versus Blood ... Conclusions. The CGM and BGM arms achieved similar and significant improvements in glycemia and other diabetes-related outcomes after 6 months in this MSKDP.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7957379/

Type 2 Diabetes and the Use of Real-Time Continuous ... When compared with control subjects, the CGM group spent 21% less time in hypoglycemia (<55 mg/dL), 23% less time in hyperglycemia (≥240 mg/dL), and 26% more ...

7. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666970622000191

Perceived impact of continuous glucose monitor use on ... Our T2DM respondents experienced a reduction in A1c, improved glucose control, and better overall health and quality of life from CGM use.

9. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/pros-cons-of-cgm

CGM l Pros and Cons of Continuous Glucose Monitors ... CGM provides continuous, real-time glucose data, eliminating the need for frequent fingerstick checks. It enhances hypoglycemia prevention, improves glycemic ...