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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how blood sugar levels fluctuate in people with diabetes, both with and without gastroparesis (a condition that slows stomach emptying). The FreeStyle Libre 3 sensor, a continuous glucose monitor, tracks these changes. Individuals who have had type 1 or type 2 diabetes for at least a year and experience symptoms of gastroparesis may be suitable candidates. Participants will observe how their glucose responds to a standard nutritional drink, potentially aiding in improved diabetes management for those with gastroparesis. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance diabetes care for those with 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 prior data suggests that the FreeStyle Libre 3 continuous glucose monitoring sensor is safe for use in patients with diabetes?

Research has shown that the FreeStyle Libre 3 sensor is generally well-tolerated. Studies have found that it sends glucose readings directly to smartphones, offering convenience and ease of use. The FDA has approved it for checking glucose levels, indicating it has passed thorough safety tests for general diabetes management.

Some users might experience minor skin irritation at the sensor site, but serious side effects are rare, and most do not report major issues. Overall, the FreeStyle Libre 3 is considered safe and effective for continuous glucose monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) with the FreeStyle Libre 3 sensor for managing diabetes with gastroparesis because it offers real-time glucose tracking, which is a significant upgrade from traditional fingerstick methods. This device provides continuous data and alerts, allowing for more precise and personalized management of blood sugar levels. Unlike some other CGM systems that might require frequent calibrations, the FreeStyle Libre 3 is factory-calibrated, making it easier and more convenient for patients to use. This continuous monitoring is especially beneficial for individuals with gastroparesis, as it helps in better understanding the impact of delayed gastric emptying on glucose levels.

What evidence suggests that the FreeStyle Libre 3 sensor is effective for monitoring glucose in patients with diabetes and gastroparesis?

Research shows that the FreeStyle Libre 3 sensor accurately tracks blood sugar levels. In earlier studies, the sensor performed well for 14 days, enhancing users' understanding of their glucose levels. About 95% of users reported a clearer understanding of their blood sugar changes, and 92% found it easier to manage their blood sugar around meals. In this trial, all participants, including those with and without gastroparesis, will use the FreeStyle Libre 3 sensor to provide reliable glucose information, serving as a helpful tool for managing diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Samita Garg, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11795573/

Performance of Three Continuous Glucose Monitoring ... This study evaluated the performance of FreeStyle Libre 3 (FL3), Dexcom G7 (DG7), and Medtronic Simplera (MSP) against different comparator methods.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06046833/continuous-glucose-metrics-in-patients-with-gastroparesis-in-type-1-or-type-2-diabetes

Continuous Glucose Metrics in Patients With Gastroparesis ... A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10064376/

Accuracy of the Third Generation of a 14-Day Continuous ... The FSL3 CGM system demonstrated accurate performance across the dynamic glycemic range during the 14-day sensor wear period.

4. provider.freestyle.abbott provider.freestyle.abbott/ca-en/proven-outcomes.html

Proven Outcomes | Healthcare Professional Proven outcomes · 95% report a better understanding of their glucose fluctuations · 92% find it easier to regulate their glucose around a meal ...

5. freestyleprovider.abbott freestyleprovider.abbott/us-en/outcomes.html

Adult & Pediatric Outcomes FreeStyle Libre CGM systems make it easy to support better outcomes by enabling greater glucose control* · Less time in hyperglycemia · Lower average glucose.

6. freestyle.abbott freestyle.abbott/us-en/safety-information.html

Safety Information | The FreeStyle Libre System Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...

7. freestyle.abbott freestyle.abbott/us-en/products/freestyle-libre-3.html

FreeStyle Libre 3 System Get the world's smallest sensor, performance you can count on and readings directly on your smartphone with the FreeStyle Libre 3 system.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223435.pdf

FreeStyle Libre 3 Continuous Glucose Monitoring This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658671/

Safety and Functional Integrity of Continuous Glucose ... Unlike traditional finger-stick blood glucose monitoring, CGM delivers a continuous stream of glucose data in numerical and graphical formats that enable ...

10. freestyle.abbott freestyle.abbott/

FreeStyle Libre Continuous Glucose Monitoring | FreeStyle ... The FreeStyle Libre 3 Plus sensor lets you see your glucose levels in real time so you can make more confident choices 1 and lower your A1C.