Continuous Glucose Monitors for Type 2 Diabetes

(DCMP Trial)

Overseen By Jill Einstein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Diabetes Solutions International

Must not be taking: Steroids

Disqualifiers: Pregnancy, Cancer, Dementia, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a continuous glucose monitor (CGM) can help individuals with uncontrolled type 2 diabetes manage their blood sugar levels and reduce distress related to the condition. Participants will wear a CGM that provides real-time glucose readings, aiding in understanding how food, exercise, and medication affect their blood sugar. A healthcare team will remotely monitor these readings to adjust treatments as needed. The trial seeks individuals with type 2 diabetes who have an A1c greater than 8%. As an unphased trial, this study offers participants the opportunity to contribute to innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that the continuous glucose monitor is used alongside usual care, which suggests you may continue your current treatment.

What prior data suggests that continuous glucose monitors are safe for individuals with type 2 diabetes?

Studies have shown that continuous glucose monitors (CGMs) are generally safe and well-tolerated by people with type 2 diabetes. Research indicates that using a CGM can improve blood sugar control and lower A1c levels, which measure average blood sugar over time.

In one study, people using CGMs experienced fewer episodes of severe hypoglycemia, with occurrences decreasing from 14.6% to 7.8%. This suggests that CGMs can help prevent dangerous low blood sugar events. Another study found that using a CGM was linked to lower death rates in patients using insulin.

Overall, these findings demonstrate that CGMs not only help manage diabetes more effectively but are also safe to use. ^{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, which is a big upgrade from the traditional finger-prick method. This continuous monitoring can help patients and doctors make more informed decisions about diet and medication by providing a constant stream of data. Additionally, combining CGMs with remote patient monitoring could enhance personalized care, allowing for adjustments to be made swiftly based on the patient's daily glucose trends. This level of proactive management has the potential to significantly improve the quality of life for those with type 2 diabetes.

What evidence suggests that using a continuous glucose monitor is effective for managing type 2 diabetes?

Research has shown that using a continuous glucose monitor (CGM), which participants in this trial will use, can improve management of type 2 diabetes. Studies have found that CGMs can lower HbA1c levels, a measure of average blood sugar over time, by about 0.32%. Users of CGMs also experienced an increase in the time their blood sugar stayed within the healthy range of 70-180 mg/dL, rising from 39.7% to 61.9%. Additionally, the time their blood sugar was too high, above 180 mg/dL, decreased from 60.1% to 37.9%. These findings suggest that CGMs can help people with type 2 diabetes control their blood sugar levels more effectively and may reduce diabetes-related stress. ^{5 6 7 8 9}

Who Is on the Research Team?

Sushma Reddy, MD

Principal Investigator

Diabetes Solutions International

Are You a Good Fit for This Trial?

This trial is for individuals with uncontrolled type 2 diabetes, particularly those underserved in healthcare. Participants will use a continuous glucose monitor (CGM) and have their glucose levels remotely monitored by a primary care team as part of their usual diabetes care.

Inclusion Criteria

I am an adult with Type 2 diabetes and my A1c is above 8%.

Exclusion Criteria

Pregnancy (participant-reported)

I have used a continuous glucose monitor for over 6 weeks recently.

I am currently taking steroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants start on CGM and RPM, using guided experiments to understand the effects of food and physical activity on glucose levels.

7-10 days

1 visit (in-person) for initial setup, followed by virtual monitoring

Main Treatment

Participants continue with CGM and RPM, with weekly reviews of RPM dashboard and treatment adjustments as needed.

24 weeks

Biweekly virtual consultations

Optional Extension

Participants may continue with CGM and RPM for an additional period to further assess long-term outcomes.

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of glucose levels and diabetes-related distress.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor (CGM)

Trial Overview The study tests if using CGM along with remote patient monitoring (RPM) can better manage blood sugar levels and reduce diabetes-related stress over a year. It checks improvements in A1c levels, time spent within target glucose range, and emotional well-being related to diabetes.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The participants will be in the intervention arm for 24 weeks with an optional 28 week extension . The intervention being studied is continuous glucose monitoring (CGM) and remote patient monitoring that is being provided as an adjunct to usual diabetes care

Who Is Running the Clinical Trial?

Diabetes Solutions International

Lead Sponsor

Tidepool

Collaborator

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

MAVEN Project

Collaborator

Published Research Related to This Trial

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

Continuous Glucose Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

Continuous glucose monitors (CGMs) have been shown to significantly improve metabolic control and reduce hypoglycemia in adults with diabetes, based on large clinical trials.

Data supporting the benefits of CGMs in children and adolescents is less robust, indicating a need for further research, especially regarding insulin dosing algorithms and their effectiveness in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Mauras, N., Fox, L., Englert, K., et al.[2021]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

Continuous glucose monitors (CGMs) have been developed and are available, but their widespread use in diabetes care is still limited due to insufficient evidence of their effectiveness in improving glycemic control for most type 1 diabetes patients.

Current studies show a lack of controlled trials demonstrating significant impacts of CGMs on important health metrics like hemoglobin A1c and hypoglycemia frequency, highlighting the need for future research to focus on patient outcomes and the overall effectiveness of CGMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitors: the long-awaited watch dogs? Wentholt, IM., Hoekstra, JB., Devries, JH.[2007]

The Cascade CGM (C-CGM) demonstrated good accuracy in measuring glucose levels, with a mean absolute relative difference (MARD) of 11.5% during in-clinic use and 12.7% during home use, indicating its effectiveness for diabetes management.

The C-CGM was found to be safe, with no serious adverse events reported during the 14-day evaluation, and it received CE Mark approval in October 2019, confirming its compliance with safety and efficacy standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Clinical Performance Evaluation of the C-CGM System. Rebec, M., Cai, K., Dutt-Ballerstadt, R., et al.[2022]

The continuous glucose monitoring system (CGMS) demonstrated high accuracy in measuring glucose levels, with a strong correlation to capillary glucose measurements (correlation coefficient of 0.87), and effectively identified glycemic excursions and postprandial hyperglycemia in diabetic patients.

After three months of using CGMS, patients showed a significant reduction in A1c levels (p=0.001), indicating improved long-term glycemic control, while 89.8% of patients experienced no complications, highlighting the system's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Metabolic/glycemic control accuracy, effect and complications of the continuous glucose monitoring system in diabetic patients]. Maia, FF., Araújo, LR.[2019]

In a study of 203 older adults (average age 68) with type 1 diabetes, continuous glucose monitoring (CGM) significantly reduced the time spent with low glucose levels (<70 mg/dL) compared to standard blood glucose monitoring (BGM), showing a decrease from 5.1% to 2.7% in the CGM group.

CGM also led to a meaningful reduction in HbA1c levels (average decrease of 0.3%) compared to BGM, indicating better overall glucose control, while the safety profile showed fewer severe hypoglycemia events in the CGM group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. Pratley, RE., Kanapka, LG., Rickels, MR., et al.[2022]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40432529/

Initiation of Continuous Glucose Monitoring and Mortality in ... Conclusion: In a large national cohort, initiation of CGM was associated with lower mortality in T2D patients using insulin and indicates use of ...

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 ...