Continuous Glucose Monitoring for Gastroparesis in Diabetes

Overseen By Jorge Araujo-Duran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Samita Garg

Must not be taking: Steroids, Immunomodulators, Opiates, others

Disqualifiers: Advanced kidney, Cardiovascular, Liver, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients with diabetes and gastroparesis and those with diabetes without gastroparesis.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. If you're on opiates, GLP-1 agonists, or motility medications, you must stop them before joining the trial. Specifically, you need to wait 2 weeks after your last dose of GLP-1 agonists and 1 week after your last dose of motility medications before enrolling.

Will I have to stop taking my current medications?

If you are taking opiates, GLP-1 agonists, or motility medications, you will need to stop them before joining the trial. Specifically, you must wait 2 weeks after your last dose of opiates or GLP-1 agonists, and 1 week after your last dose of motility medications before enrolling.

What safety data exists for the FreeStyle Libre 3 glucose monitoring system?

The safety data for the FreeStyle Libre glucose monitoring system includes reports of allergic contact dermatitis caused by isobornyl acrylate in the sensor. Additionally, there is a study evaluating the safety and effectiveness of a similar continuous glucose monitoring system, the FreeStyle Navigator, for home use by adults with diabetes. These studies suggest that while the system is generally safe, there may be skin-related side effects for some users. ^{1 2 3 4 5}

Is the FreeStyle Libre 3 continuous glucose monitoring system safe for humans?

The FreeStyle Libre glucose monitoring system is generally safe for humans, but some users have reported allergic skin reactions (contact dermatitis) from the adhesive used in the sensor. ^{1 2 3 4 5}

Is continuous glucose monitoring a promising treatment for gastroparesis in diabetes?

Continuous glucose monitoring, like the FreeStyle Libre system, is a promising treatment for managing diabetes. It helps track glucose levels continuously, which can improve blood sugar control and quality of life for people with diabetes. ^{2 4 6 7 8}

How is continuous glucose monitoring unique for treating gastroparesis in diabetes?

Continuous glucose monitoring (CGM) is unique for treating gastroparesis in diabetes because it provides real-time tracking of glucose levels, which can help manage the unpredictable blood sugar fluctuations caused by gastroparesis. Unlike traditional methods that require finger-prick blood tests, CGM uses a sensor under the skin to continuously measure glucose, offering more detailed insights into glucose trends and helping to adjust treatment plans more effectively. ^{2 4 6 7 8}

What data supports the idea that Continuous Glucose Monitoring for Gastroparesis in Diabetes is an effective treatment?

The available research shows that the FreeStyle Libre system, a type of continuous glucose monitoring, is effective for diabetes management. It provides continuous glucose readings without the need for frequent finger pricks, which can improve the quality of life for patients. Although the studies focus on diabetes in general, they highlight the system's accuracy and convenience, which can be beneficial for managing conditions like gastroparesis in diabetes. However, there is no specific data in the provided research directly linking it to gastroparesis treatment. ^{2 3 4 8 9}

What data supports the effectiveness of the treatment FreeStyle Libre 3 continuous glucose monitoring sensor for gastroparesis in diabetes?

The FreeStyle Libre system, used for continuous glucose monitoring, has been shown to be accurate and effective in managing blood sugar levels in people with diabetes, as it provides continuous data without the need for frequent finger pricks. This can help improve overall glucose control, which is beneficial for managing diabetes-related conditions like gastroparesis. ^{2 3 4 8 9}

Research Team

Samita Garg, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults over 18 with type 1 or type 2 diabetes and a recent Hemoglobin A1c ≤11%. It's specifically for those who've had diabetes for at least a year without severe incidents in the past three months. Participants should have gastroparesis symptoms for three months, confirmed by tests, and must use a smartphone compatible with the LibreView App.

Inclusion Criteria

You have a smartphone that can use the LibreView app, which works on iPhones and Android phones.

I haven't had severe diabetes complications requiring hospital visits in the last 3 months.

I have had gastroparesis symptoms for at least 3 months.

Exclusion Criteria

My liver disease could affect my blood sugar levels.

I am taking steroids, immunomodulators, or undergoing chemoradiation.

My kidney function is severely reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the FreeStyle Libre 3 sensor for Continuous Glucose Monitoring and participate in standardized meal challenges over a period of 28 days

4 weeks

2 visits (in-person) for meal challenges

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FreeStyle Libre 3 continuous glucose monitoring sensor

Trial Overview The study is testing how well the FreeStyle Libre 3 sensor monitors blood sugar levels in patients with both diabetes and gastroparesis compared to diabetic patients without gastroparesis. It also looks at how nutritional drinks affect these metrics.

Participant Groups

Group I: Patients with type 1 or type 2 diabetes and gastroparesis Experimental Treatment 2 Interventions

Both groups will have the same intervention. * FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. * Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge.

Group II: Patients with type 1 or type 2 diabetes without gastroparesis Active Control 2 Interventions

Both groups will have the same intervention. * FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. * Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge

Who Is Running the Clinical Trial?

Samita Garg

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

The first-generation FreeStyle Libre isCGM device showed a mean average relative difference (MARD) of 15.6% in sensor glucose levels compared to capillary blood glucose, indicating a moderate level of accuracy in monitoring glucose levels among 91 participants.

Participants with contact dermatitis experienced a significantly higher MARD of 27.4%, suggesting that skin complications may negatively impact the accuracy of glucose readings from the isCGM device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible Relationship between the Deteriorated Accuracy of Intermittent-Scanning Continuous Glucose Monitoring Device and the Contact Dermatitis: Post-hoc analysis of the ISCHIA Study. Toyoda, M., Murata, T., Hirota, Y., et al.[2023]

A study involving 15 patients revealed that the FreeStyle® Libre glucose sensor can cause allergic contact dermatitis, primarily due to its adhesive component.

Isobornyl acrylate was identified as a significant allergen in these cases, with 12 out of 13 tested patients showing sensitization to it, highlighting the need for awareness of potential allergic reactions to this medical device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis caused by isobornyl acrylate in Freestyle® Libre, a newly introduced glucose sensor. Herman, A., Aerts, O., Baeck, M., et al.[2022]

The FreeStyle Libre Flash continuous glucose monitoring system (FSL-CGM) demonstrated high accuracy at alternative sites, with the chest and back sensors showing 98% and 97.9% accuracy compared to the arm sensor in a study involving 20 participants with type 1 diabetes.

Participants preferred the arm and chest sensor sites for their accuracy and usability, although all sensors showed greater variability during rapid glucose changes, highlighting the need for careful interpretation of readings during such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where can you wear your Libre? Using the FreeStyle Libre continuous glucose monitor on alternative sites. Hall, RM., Dyhrberg, S., McTavish, A., et al.[2022]

The FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system showed that 85.5% of its readings from the arm fell within the clinically acceptable range when compared to a standard blood glucose measurement, indicating good efficacy for monitoring glucose levels in patients with diabetes.

However, the FSL-CGM system tended to underestimate glucose levels at lower ranges and overestimate them at higher ranges, particularly after meals, suggesting that users should be cautious and follow optimized instructions for accurate daily management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. Fokkert, MJ., van Dijk, PR., Edens, MA., et al.[2022]

The study involving 21 participants with type 1 diabetes found that the c-rtCGM device provided accurate glucose readings compared to the FreeStyle Libre sensor (FSL) only when daily calibrations were performed, achieving a mean absolute relative difference (MARD) of 12.06%.

Without calibration, the c-rtCGM showed significantly decreased accuracy, with a MARD of 17.49%, particularly in hypoglycemic ranges and during rapid glucose changes, indicating the importance of regular calibration for reliable glucose monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of an Off-Label Transmitter and Data Manager Paired With an Intermittent Scanned Continuous Glucose Monitor in Adults With Type 1 Diabetes. Villa-Tamayo, MF., Builes-Montaño, CE., Ramirez-Rincón, A., et al.[2022]

A study involving 62 subjects with diabetes demonstrated that a modified continuous glucose monitoring sensor can be worn safely for 14 days, showing excellent in vivo stability with minimal sensitivity loss.

The sensor without recalibration outperformed the recalibrated version, achieving a mean absolute relative difference (MARD) of 12.2% and 88.0% accuracy in the most clinically relevant zone, indicating its potential for reliable long-term glucose monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in the subcutaneous tissue over a 14-day sensor wear period. Hoss, U., Budiman, ES., Liu, H., et al.[2021]

The FreeStyle Navigator Continuous Glucose Monitoring System was found to be safe and effective for adults with type 1 or 2 diabetes, significantly reducing time spent in hypoglycemia by 55% during the unmasked period of the study.

Participants reported high satisfaction with the system, and the accuracy of glucose readings was validated, with 77.2% of results falling in the clinically acceptable Clarke error grid zone A, indicating reliable monitoring for better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a continuous glucose monitoring system for home-use conditions. Bode, B., Silver, M., Weiss, R., et al.[2019]

In a study involving 10 participants using continuous glucose monitoring (CGM), significant differences in glucose readings were found between the right and left arms, with the right arm showing a higher mean glucose level (89.1 mg/dL) compared to the left (85.3 mg/dL).

The time spent in the target glucose range (70-180 mg/dL) was also significantly different, with the right arm being out of range 12.7% of the time versus 18.5% for the left arm, indicating that the choice of arm for CGM application can affect glucose monitoring results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in glucose level between right arm and left arm using continuous glucose monitors. Kim, N., Pham, K., Shek, A., et al.[2022]

The second-generation FreeStyle Navigator Continuous Glucose Monitoring System significantly reduced the warm-up period from 10 hours to just 1 hour, allowing for quicker glucose monitoring after sensor insertion.

In a study with 47 type 1 diabetes subjects, the new system maintained high clinical accuracy, with 92.6% of readings being clinically accurate during the first 10 hours, similar to the accuracy in subsequent hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FreeStyle Navigator Continuous Glucose Monitoring System with TRUstart algorithm, a 1-hour warm-up time. Geoffrey, M., Brazg, R., Richard, W.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Possible Relationship between the Deteriorated Accuracy of Intermittent-Scanning Continuous Glucose Monitoring Device and the Contact Dermatitis: Post-hoc analysis of the ISCHIA Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis caused by isobornyl acrylate in Freestyle® Libre, a newly introduced glucose sensor. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Where can you wear your Libre? Using the FreeStyle Libre continuous glucose monitor on alternative sites. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]

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

Accuracy of an Off-Label Transmitter and Data Manager Paired With an Intermittent Scanned Continuous Glucose Monitor in Adults With Type 1 Diabetes. [2022]

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

Continuous glucose monitoring in the subcutaneous tissue over a 14-day sensor wear period. [2021]

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

Evaluation of a continuous glucose monitoring system for home-use conditions. [2019]

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

Differences in glucose level between right arm and left arm using continuous glucose monitors. [2022]

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

FreeStyle Navigator Continuous Glucose Monitoring System with TRUstart algorithm, a 1-hour warm-up time. [2022]