Continuous Glucose Monitors for Uncontrolled Type 2 Diabetes

Overseen By Anne Camp, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Insulin

Disqualifiers: Insulin naive, DKA, ESRD, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous glucose monitors (CGMs) can assist people with poorly controlled type 2 diabetes in managing blood sugar levels and enhancing quality of life. Participants will receive a free CGM device, which tracks blood sugar in real-time, to determine its effectiveness in improving diabetes control. The trial suits those who have used insulin for at least a year, struggle to afford CGM sensors, and have an A1c level of 8.0 or higher, indicating high blood sugar levels. As an unphased trial, this study provides a unique opportunity to access innovative technology that may enhance diabetes management and improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to follow any medication adjustments your provider suggests.

What prior data suggests that Continuous Glucose Monitors are safe for use in patients with type 2 diabetes?

Studies have shown that Continuous Glucose Monitors (CGMs) are generally safe for people with diabetes. These small devices attach to the body and provide real-time updates on blood sugar levels. Research indicates that using a CGM can help individuals with poorly controlled diabetes manage their blood sugar more effectively.

Previous studies reported that patients handled CGMs well, with no serious side effects. Some users might initially find the device uncomfortable, but this usually improves over time. No reports suggest that CGMs cause harm when used correctly.

For those with uncontrolled type 2 diabetes considering a clinical trial with CGMs, current evidence supports their safety. They are widely used for managing diabetes and are recommended by doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Glucose Monitors (CGMs) for uncontrolled Type 2 diabetes because they offer real-time glucose tracking, which is a step up from traditional finger-prick tests. Unlike standard care, which often relies on periodic blood sugar checks, CGMs provide continuous data, allowing people to see how their glucose levels fluctuate throughout the day. This continuous monitoring can lead to more precise adjustments in diet and medication, potentially improving blood sugar control more effectively than current methods. Moreover, by wearing the sensor for an extended period, individuals can better understand their body's response to different foods and activities, which can empower them to make informed lifestyle changes.

What evidence suggests that Continuous Glucose Monitors are effective for uncontrolled type 2 diabetes?

Studies have shown that Continuous Glucose Monitors (CGMs), which participants in this trial will use, help people with type 2 diabetes manage their blood sugar levels more effectively. Research indicates that using a CGM leads to a noticeable decrease in HbA1c, an important measure of long-term blood sugar control. In some studies, people using CGMs adjusted their diabetes treatments more effectively, resulting in better overall blood sugar management. While most studies focus on those not using insulin, evidence suggests that CGMs benefit anyone looking to improve diabetes management. Overall, CGMs provide real-time blood sugar information, aiding in better decisions about diet and medication. ^{2 3 6 7 8}

Who Is on the Research Team?

Kasia Lipska, MD MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with poorly controlled type 2 diabetes who are patients at Fair Haven Community Health Care. It's designed to see if using a Continuous Glucose Monitor (CGM) helps manage their condition better.

Inclusion Criteria

A1c greater than or equal to 8.0 within two weeks of the time of enrollment

I have been on insulin for at least a year, with or without other diabetes medications.

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Pregnancy

Contraindications to CGM use

I have not had diabetic ketoacidosis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CGM sensors and are instructed on their use. Medication adjustments are made based on CGM data.

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional A1c measurements and questionnaire completions.

12 weeks

1 visit (in-person) at 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor (CGM)

Trial Overview The study provides free CGM sensors to participants and observes any changes in blood sugar control and quality of life before and after the use of CGMs, without comparing different groups or treatments.

How Is the Trial Designed?

Group I: Poorly Controlled Type 2 Diabetes- CGM Experimental Treatment 1 Intervention

Participants will have CGM sensor placed at first visit and will be worn for 12 weeks. Sensor must be scanned 3 times daily. Adjustments to medication regimen will be recommended at 6 weeks. Follow-up appointments will be at 12 weeks and 24 weeks.

Continuous Glucose Monitor (CGM) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Approved in European Union as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Approved in Canada as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Yale Office of Global Health

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study involving 27 subjects over 14 days, the Dexcom G5 Mobile (rtCGM) demonstrated higher accuracy than the FreeStyle Libre (isCGM), with 91.5% of its readings within ±20% of laboratory results compared to 82.5% for FreeStyle Libre.

The mean absolute relative difference (MARD) was lower for the Dexcom G5 at 9.5%, indicating it provided more precise glucose readings than the FreeStyle Libre, which had a MARD of 13.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. Link, M., Kamecke, U., Waldenmaier, D., et al.[2021]

The use of the Dexcom G6 real-time continuous glucose monitoring (rtCGM) system in a newborn with prolonged hypoglycemia due to congenital hyperinsulinism demonstrated high effectiveness, maintaining glucose levels above 70 mg/dL and keeping time in the target range consistently above 90%.

The off-label use of rtCGM allowed for better glycemic control and reduced the need for invasive blood glucose checks, highlighting the potential benefits of customizable alert settings for managing glycemic instability in newborns and other patient groups beyond diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Source Technology for Real-Time Continuous Glucose Monitoring in the Neonatal Intensive Care Unit: Case Study in a Neonate With Transient Congenital Hyperinsulinism. Braune, K., Wäldchen, M., Raile, 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 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 monitoring (CGM) was analyzed in 53 diabetic patients, primarily those with type 1 diabetes (90.5%), and was found to be effective in detecting asymptomatic hypoglycemic events and guiding therapy changes in 64.5% of cases.

The method provided additional information that improved glycemic control and potentially life expectancy in type 1 diabetes patients, but it was noted to be less effective for type 2 diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. Bagosi, Z., Oroszlán, T., Bujtor, Z., et al.[2022]

Real-time continuous glucose monitoring (rtCGM) systems provide automatic glucose data transmission, alerts, and alarms, making them more user-friendly and responsive compared to intermittently scanned (isCGM) systems, which require manual scanning for data retrieval.

Both rtCGM and isCGM offer significant advantages over traditional blood glucose self-monitoring, but the choice between them should be based on individual patient needs and preferences due to their differing features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. Edelman, SV., Argento, NB., Pettus, J., et al.[2019]

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]

Real-time continuous glucose monitoring (RT-CGM) is a valuable tool for diabetes management, helping to detect nocturnal or unrecognized hypoglycemia and improve treatment decisions, which can enhance metabolic control and reduce diabetes complications.

Despite some limitations like lag time and the need for calibration, RT-CGM devices are generally accurate and user-friendly, making it feasible to implement a clinical RT-CGM program with proper patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time continuous glucose monitoring in the clinical setting: the good, the bad, and the practical. Mamkin, I., Ten, S., Bhandari, S., et al.[2021]

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 a study of 65 patients with poorly controlled type 2 diabetes, those using a real-time continuous glucose monitoring system (RT-CGM) showed a significant reduction in HbA1c levels from 9.1% to 8.0% over 12 weeks, compared to a smaller reduction in the self-monitoring blood glucose (SMBG) group.

The RT-CGM group also experienced improvements in lifestyle factors, including reduced calorie intake, weight loss, lower body mass index (BMI), and increased exercise time, indicating that RT-CGM not only aids in glucose control but also promotes healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Yoo, HJ., An, HG., Park, SY., et al.[2022]

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]

Real-time continuous glucose monitoring (RT-CGM) significantly reduces HbA1c levels in patients with type 1 diabetes compared to self blood glucose measurement (SBGM), based on a systematic review of 7 randomized controlled trials involving 948 participants.

The use of RT-CGM does not increase the risk of major hypoglycemic episodes, and consistent use (over 60-70% of the time) is linked to better glucose control, indicating its safety and efficacy in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. Szypowska, A., Ramotowska, A., Dzygalo, K., et al.[2022]

A program for real-time continuous glucose monitoring (rtCGM) in hospitalized patients with diabetes showed a mean absolute relative difference (MARD) of 10.3% when compared to traditional blood glucose measurements, indicating good accuracy for monitoring glucose levels.

The study found that 99.2% of rtCGM data points were clinically acceptable, suggesting that while rtCGM can effectively alert for hypoglycemia, insulin dosing should still rely on fingerstick measurements to avoid potential discrepancies in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical implementation of remote continuous glucose monitoring in hospitalized patients with diabetes. Baker, M., Musselman, ME., Rogers, R., et al.[2022]

The user-calibrated real-time continuous glucose monitoring (rt-CGM) system demonstrated superior accuracy compared to the factory-calibrated flash glucose monitoring (FGM) system, with a mean absolute relative difference of 9.7% for rt-CGM versus 17.5% for FGM, indicating better performance in tracking blood glucose levels.

Despite the higher accuracy of rt-CGM, both systems were generally perceived as easy to use and helpful for managing diabetes, although cost concerns limited the willingness of participants to adopt either device for continuous monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A head-to-head comparison between Guardian Connect and FreeStyle Libre systems and an evaluation of user acceptability of sensors in patients with type 1 diabetes. Yeoh, E., Png, D., Khoo, J., et al.[2022]

Citations

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The Effectiveness of Continuous Glucose Monitoring ... This retrospective study aimed to assess the effectiveness of continuous glucose monitoring (CGM) devices in managing uncontrolled diabetes mellitus (DM).

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Continuous glucose monitoring in noninsulin‐treated type 2 ... Conclusions drawn from observational trials are limited by the inherent bias in uncontrolled trials, their small population sizes, and their ...

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Continuous Glucose Monitoring | Diabetes Care (37) reported on a study of the prolonged effects of a 72-h course of CGMS monitoring in a nonrandomized, uncontrolled trial with 28 type 1 diabetic subjects.

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Advances in Continuous Glucose Monitoring: Clinical ... Impact of reducing glycated hemoglobin on healthcare costs among a population with uncontrolled diabetes. Appl Health Econ Health Policy ...

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Continuous glucose monitoring based glycemic control ... In addition, identifying barriers to routine HbA1c testing in uncontrolled ... glucose monitoring (CGM) data to optimize glucose control in type 2 diabetes.

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Using Continuous Glucose Monitoring in Clinical Practice Some may require a certificate of medical necessity, whereas others may need documentation of uncontrolled diabetes while using an MDI insulin regimen, insulin- ...

7. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) What is a CGM? CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.

8. thelancet.com thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00061-0/fulltext

Real-time continuous glucose monitoring-guided ... Moreover, STII is also a generally preferred treatment option for people with uncontrolled type 2 diabetes in China and is recommended by the ...