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

Trial Summary

What is the purpose of this trial?

The goal of this 52 week prospective study is to learn whether a Diabetes Care Management Program using a continuous glucose monitor (CGM) and remotely monitoring (RPM) glucose readings can help improve glucose levels and diabetes related distress in individuals with uncontrolled type 2 diabetes. The CGM and RPM are used as an adjunct to usual care. The main questions it aims to answer are: Does use of CGM \& RPM improve A1c? Does use of CGM \& RPM improve the percent of time spent with glucose levels between 70-180 mg/dl? Does the diabetes care management program improve diabetes related distress? Participants enrolled in the study will be wearing a CGM. Participants will be able to see the glucose readings from the CGM and see how their glucose level responds to food, physical activity, medications and daily life. The diabetes primary care team will be remotely monitoring the participant's glucose data from the CGM. They will reach out to the participant to make adjustments in treatment regimen as needed. Participants will answer a "Problem Areas in Diabetes"questionnaire that asks questions about diabetes related distress.

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 data supports the effectiveness of the treatment Continuous Glucose Monitor (CGM) for Type 2 Diabetes?

Research shows that continuous glucose monitors (CGMs) help people with diabetes better manage their blood sugar levels by providing real-time data and alerts for high or low blood sugar, which can improve overall glucose control without increasing the risk of low blood sugar episodes. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors (CGMs) have been associated with a significant number of adverse events, with 281,963 reported in 2022. However, specific safety data for CGMs in various conditions, including type 2 diabetes, is limited, and more research is needed to fully understand their safety profile. ^{6 7 8 9 10}

How is continuous glucose monitoring different from other treatments for type 2 diabetes?

Continuous glucose monitoring (CGM) is unique because it provides real-time tracking of glucose levels, allowing for better glucose control and reducing the risk of low blood sugar without increasing hypoglycemia. Unlike traditional methods, CGM offers continuous data and alerts for glucose changes, which can be particularly beneficial for those using insulin. ^{3 5 10 11 12}

Research Team

Sushma Reddy, MD

Principal Investigator

Diabetes Solutions International

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitors: the long-awaited watch dogs? [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Clinical Performance Evaluation of the C-CGM System. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring-Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes. [2022]