Continuous Glucose Monitoring for Type 2 Diabetes
(REMIT2D isCGM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a continuous glucose monitor (a device that tracks sugar levels in real-time) can help people with type 2 diabetes achieve remission (return to normal or near-normal sugar levels) when combined with a low-calorie meal plan and diabetes education. The study compares this method to traditional finger-prick blood sugar tests (capillary blood glucose monitoring). Individuals who have had type 2 diabetes for more than 6 months but less than 6 years, are on no more than three diabetes medications (excluding insulin), and are willing to follow a low-calorie meal plan might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management strategies.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it mentions that participants should not be using insulin and should be treated with 3 or fewer non-insulin diabetes medications. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intermittently scanned continuous glucose monitoring (isCGM) is generally safe for people with type 2 diabetes. Studies have found that isCGM helps lower HbA1c levels, improving blood sugar control. Users report it is easy to use, with no major safety issues.
For those taking insulin or other diabetes medications, isCGM has proven effective and safe. People using this technology often feel more satisfied compared to traditional methods, suggesting that isCGM is a reliable way to manage diabetes without major side effects.
Overall, evidence supports that isCGM is safe and can be an effective part of diabetes management.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores different ways to manage Type 2 Diabetes by comparing traditional and newer monitoring methods. The trial looks at capillary blood glucose monitoring, which is a common standard where patients prick their finger to check blood sugar levels, versus an intermittently scanned continuous glucose monitor (isCGM). The isCGM provides more real-time data without the need for constant finger pricking, potentially offering patients a more convenient and comfortable way to track their glucose levels. Additionally, both groups receive a low-calorie meal replacement plan and diabetes self-management education, which could enhance overall diabetes control and quality of life. This trial seeks to find out if these combined approaches can improve diabetes management more effectively than current methods.
What evidence suggests that this trial's treatments could be effective for type 2 diabetes?
In this trial, participants will be divided into two groups to evaluate different glucose monitoring strategies. Research has shown that intermittently scanned continuous glucose monitoring (isCGM), one of the strategies tested in this trial, can help people with type 2 diabetes manage their blood sugar more effectively. Studies have found that isCGM can lower HbA1c levels, an important measure of long-term blood sugar control. This benefit occurs in patients regardless of insulin use. Additionally, isCGM provides real-time information about glucose levels, aiding patients in making healthier lifestyle choices. Overall, using isCGM alongside lifestyle changes can lead to better diabetes management.34678
Are You a Good Fit for This Trial?
This trial is for adults with type 2 diabetes who are starting a low-calorie meal replacement and diabetes self-management education. Participants should not be using any antihyperglycemic agents for at least three months prior to the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Total Dietary Replacement
Participants undergo total dietary replacement as part of the intervention
Food Re-introduction
Participants gradually reintroduce food while continuing diabetes self-management education
Remission
Participants are monitored for remission of type 2 diabetes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capillary blood glucose monitoring
- Diabetes self management education
- Intermittently scanned continuous glucose monitoring
- Low calorie meal replacement plan
Find a Clinic Near You
Who Is Running the Clinical Trial?
LMC Diabetes & Endocrinology Ltd.
Lead Sponsor
Abbott Diabetes Care
Industry Sponsor
Robert B. Ford
Abbott Diabetes Care
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Dr. Mahmood Kazemi
Abbott Diabetes Care
Chief Medical Officer
Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco