Continuous Glucose Monitoring for Gastroparesis in Diabetes
Recruiting in Palo Alto (17 mi)
Overseen bySamita Garg, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Samita Garg
No Placebo Group
Approved in 2 Jurisdictions
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.
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.
12345What 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.
12367Is 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.
13489Eligibility 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.
+5 more
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.
+12 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Patients with type 1 or type 2 diabetes and gastroparesisExperimental Treatment2 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 gastroparesisActive Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic FoundationCleveland, OH
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Who Is Running the Clinical Trial?
Samita GargLead Sponsor
References
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]We previously reported the mean average relative difference (MARD) of the sensor glucose (SG) of the first-generation FreeStyle Libre with the original algorithm, an intermittent scanning continuous glucose monitoring (isCGM) device, was 15.6% in the Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study). In the present study, we aimed to further analyze its accuracy in detail by conducting a post-hoc analysis of the study.
Allergic contact dermatitis caused by isobornyl acrylate in Freestyle® Libre, a newly introduced glucose sensor. [2022]Glucose sensors, such as FreeStyle® Libre, are innovative medical devices developed for diabetes patients as a replacement for classic glucose meters, ensuring continuous glucose monitoring without the disadvantage of regular skin finger pricks.
Where can you wear your Libre? Using the FreeStyle Libre continuous glucose monitor on alternative sites. [2022]To investigate the accuracy and acceptability of the FreeStyle Libre Flash continuous glucose monitoring system (FSL-CGM) at alternative sites during free living and under experimental conditions.
Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods.
Accuracy of an Off-Label Transmitter and Data Manager Paired With an Intermittent Scanned Continuous Glucose Monitor in Adults With Type 1 Diabetes. [2022]This work evaluates the accuracy and agreement between the FreeStyle Libre sensor (FSL) and an off-label converted real-time continuous glucose monitor (c-rtCGM) device consisting of the MiaoMiao transmitter and the xDrip+ application which can be coupled to the FSL.
Continuous glucose monitoring in the subcutaneous tissue over a 14-day sensor wear period. [2021]Glucose monitoring systems using subcutaneously inserted sensors are currently labeled for up to 7 days of wear. In this study, we evaluated the feasibility of a 14-day wear duration using a modified version of the sensor found in the Freestyle Navigator™ continuous glucose monitoring system.
Evaluation of a continuous glucose monitoring system for home-use conditions. [2019]To evaluate the safety and effectiveness of the FreeStyle Navigator Continuous Glucose Monitoring System when used by adult patients with type 1 or 2 diabetes requiring insulin in the home environment.
Differences in glucose level between right arm and left arm using continuous glucose monitors. [2022]Continuous glucose monitoring (CGM) measures interstitial glucose levels through a sensor with a thin filament inserted under the skin. It is customary for patients to rotate sensor application sites between arms to minimize skin irritation. However, there is limited data regarding the degree of inter-arm differences with CGM technology.
FreeStyle Navigator Continuous Glucose Monitoring System with TRUstart algorithm, a 1-hour warm-up time. [2022]The first-generation FreeStyle Navigator® Continuous Glucose Monitoring System (FreeStyle Navigator CGM) requires a 10 h warm-up period to avoid inaccurate glucose readings caused by sensor insertion trauma and wound-healing processes. The performance of a second-generation FreeStyle Navigator CGM that begins reporting glucose 1 h after sensor insertion is described.