Diabetes Mellitus, Type 2NCT06046833
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
A study testing FreeStyle Libre 3 continuous glucose monitoring sensor and Nutritional drink in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Samita Garg at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
- What is being tested?
- FreeStyle Libre 3 continuous glucose monitoring sensor and Nutritional drink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years.
- Hemoglobin A1c ≤11% within the last 6 months.
- Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year.
- Normal thyroid-stimulating hormone (TSH) within the last year.
- No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 2 weeks requiring ER visit or hospitalization.
- Symptoms of gastroparesis have been present for at least the past 3 months, in patients with gastroparesis.
- In patients with gastroparesis, documented delayed gastric emptying on scintigraphy and/or wireless motility capsule (Smart Pill) as defined by greater than 10% retention at 4 hours or greater than 4-hour gastric transit time (GTT) in the past five years.
- Patients using a Smartphone (iPhone or Android) compatible with LibreView App.
Who cannot join
- Hemoglobin A1c of >11% at enrollment.
- Advanced chronic kidney disease (serum creatinine of >2 mg/dL or estimated glomerular filtration rate (eGFR) <30mL/min/1.73m² using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).
- Advanced and significant cardiovascular disease or unstable angina.
- Advanced liver disease that may affect glucose profiles.
- Post-transplant patients.
- History of gastric surgery.
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- Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment.
- Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days.
- Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles.
- Patients on opiates or glucagon-like peptide-1 (GLP-1) agonists (Ozempic, Wegovy, Mounjaro, Trulicity). If previously taking these medications, patients can be enrolled after 2 weeks of the last dose.
- Patient on recreational or illicit drugs (i.e., marijuana, opiates, cocaine, etc.).
- Patients on motility medications such as Reglan (Metoclopramide), Motegrity (Prucalopride), Cisapride, Domperidone, Erythromycin. If previously taking any of these medications, patients can be enrolled after 1 week of the last dose.
- Clinically significant abnormalities on upper GI endoscopy.
- Presence of imaging evidence of gastric or intestinal obstruction.
- Patient previously participated in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Samita Garg, MD, 216-444-2384, gargs@ccf.org
Jorge Araujo-Duran, MD, 216-444-7935, araujoj@ccf.org
About this study
Official title: Glucose Metrics Using Freestyle Libre 3 Real-Time Continuous Glucose Monitor (rtCGM) in Patients With Gastroparesis in Type 1 or Type 2 Diabetes: Investigator Initiated Pilot Study
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.
Read the detailed description
Investigators will analyze and compare various Glucose Metrics (GM) derived from a Continuous Glucose Monitor (CGM) between individuals with diabetes and gastroparesis and those with diabetes without gastroparesis over a period of 28 days and during two standardized meal challenge visits. Furthermore, the investigators aim to assess whether there is an association between gastroparesis and GM parameters.
The objective is to propose a new tool (Diabetic Gastroparesis Index or Score) to assess for early gastroparesis in patients with diabetes using the identified and analyzed GM. This may help patients and providers to recognize gastroparesis early and facilitate necessary medical interventions.
Hyperglycemia and hypoglycemia episodes will be monitored throughout the study for both groups and their association with GM and gastroparesis will be evaluated.
The Gastroparesis Cardinal Symptom Index (GCSI) and the Gastrointestinal Quality of Life Index (GIQLI) questionnaires will be performed to assess the association of gastroparesis symptoms with GM.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
- Being tested
- FreeStyle Libre 3 continuous glucose monitoring sensor, Nutritional drink
- Keywords
- Gastroparesis, Diabetes, Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 3 continuous glucose monitoring sensorDevice
Also called FreeStyle Libre 3 system
The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
Nutritional drinkOther
Also called Boost plus
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 or type 2 diabetes and gastroparesis | Experimental | 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. Receives: Device: FreeStyle Libre 3 continuous glucose monitoring sensor; Other: Nutritional drink |
| Patients with type 1 or type 2 diabetes without gastroparesis | Active comparator | 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 Receives: Device: FreeStyle Libre 3 continuous glucose monitoring sensor; Other: Nutritional drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-in-Range (TIR)
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) in target glucose range 70-180 mg/dL.
Measured: 28 days of monitoring
Time-in-Tight Range (TITR)
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) in target glucose range 70-140 mg/dL.
Measured: 28 days of monitoring
Time Below Range (TBR)
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) with glucose <70 mg/dL (including readings <54 mg/dL)
Measured: 28 days of monitoring
Time Above Range (TAR)
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) with >180 mg/dL (including readings >250 mg/dL).
Measured: 28 days of monitoring
Metrics of Glucose Variability
- Standard Deviation (SD)
- Coefficient of Variation (CV)
- Glucose Management Indicator (GMI)
- Mean Amplitude of Glucose Excursion (MAGE)
- Mean Of Daily Differences (MODD)
- Mean Indices of Meal Excursion (MIME)
- Continuous overall net glycemic action (CONGA)
- Low Blood Glucose Index (LBGI)
- High Blood Glucose Index (HBGI)
Measured: 28 days of monitoring
Secondary outcomes (2)
Hyperglycemia episodes
At least 15 minutes or longer of Time-Above Range (TAR) 181-250 mg/dL (Level 1 hyperglycemia) and >250 mg/dl (Level 2 hyperglycemia)
Measured: 28 days of monitoring
Hypoglycemia episodes
At least 15 minutes or longer of Time-Below-Range (TBR) 54-69 mg/dL (Level 1 hypoglycemia) or <54 mg/dL (Level 2 hypoglycemia)
Measured: 28 days of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Same intervention for two cohorts
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samita Garg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samita Garg, The Cleveland Clinic
- Investigators
- Samita Garg, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046833
- Sponsor's protocol ID
- 23-594
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Metrics Using Freestyle Libre 3 Real-Time Continuous Glucose Monitor (rtCGM) in Patients With Gastroparesis in Type 1 or Type 2 Diabetes: Investigator Initiated Pilot Study
- ClinicalTrials.gov ID
- NCT06046833
- Acronym / sponsor ID
- 23-594
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
- Keywords
- Gastroparesis, Diabetes, Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samita GargUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators will analyze and compare various Glucose Metrics (GM) derived from a Continuous Glucose Monitor (CGM) between individuals with diabetes and gastroparesis and those with diabetes without gastroparesis over a period of 28 days and during two standardized meal challenge visits. Furthermore, the investigators aim to assess whether there is an association between gastroparesis and GM parameters.
The objective is to propose a new tool (Diabetic Gastroparesis Index or Score) to assess for early gastroparesis in patients with diabetes using the identified and analyzed GM. This may help patients and providers to recognize gastroparesis early and facilitate necessary medical interventions.
Hyperglycemia and hypoglycemia episodes will be monitored throughout the study for both groups and their association with GM and gastroparesis will be evaluated.
The Gastroparesis Cardinal Symptom Index (GCSI) and the Gastrointestinal Quality of Life Index (GIQLI) questionnaires will be performed to assess the association of gastroparesis symptoms with GM.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Same intervention for two cohorts
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 or type 2 diabetes and gastroparesis | Experimental | Device: FreeStyle Libre 3 continuous glucose monitoring sensor, Other: Nutritional drinkBoth 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. |
| Patients with type 1 or type 2 diabetes without gastroparesis | Active comparator | Device: FreeStyle Libre 3 continuous glucose monitoring sensor, Other: Nutritional drinkBoth 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over the age of 18 years.
- Hemoglobin A1c ≤11% within the last 6 months.
- Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year.
- Normal thyroid-stimulating hormone (TSH) within the last year.
- No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 2 weeks requiring ER visit or hospitalization.
Key exclusion criteria (15 listed)
- Hemoglobin A1c of >11% at enrollment.
- Advanced chronic kidney disease (serum creatinine of >2 mg/dL or estimated glomerular filtration rate (eGFR) <30mL/min/1.73m² using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).
- Advanced and significant cardiovascular disease or unstable angina.
- Advanced liver disease that may affect glucose profiles.
- Post-transplant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre 3 continuous glucose monitoring sensorAlso: FreeStyle Libre 3 systemThe Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute | Device | Patients with type 1 or type 2 diabetes and gastroparesis, Patients with type 1 or type 2 diabetes without gastroparesis |
| Nutritional drinkAlso: Boost plusBalanced nutritional drink (Boost plus 8 ounces/237 mL) | Other | Patients with type 1 or type 2 diabetes and gastroparesis, Patients with type 1 or type 2 diabetes without gastroparesis |
Primary outcome
Time-in-Range (TIR)
Time frame: 28 days of monitoring
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) in target glucose range 70-180 mg/dL.
Time-in-Tight Range (TITR)
Time frame: 28 days of monitoring
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) in target glucose range 70-140 mg/dL.
Time Below Range (TBR)
Time frame: 28 days of monitoring
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) with glucose <70 mg/dL (including readings <54 mg/dL)
Time Above Range (TAR)
Time frame: 28 days of monitoring
Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) with >180 mg/dL (including readings >250 mg/dL).
Metrics of Glucose Variability
Time frame: 28 days of monitoring
* Standard Deviation (SD) * Coefficient of Variation (CV) * Glucose Management Indicator (GMI) * Mean Amplitude of Glucose Excursion (MAGE) * Mean Of Daily Differences (MODD) * Mean Indices of Meal Excursion (MIME) * Continuous overall net glycemic action (CONGA) * Low Blood Glucose Index (LBGI) * High Blood Glucose Index (HBGI)
2 secondary outcomes
Hyperglycemia episodes
Time frame: 28 days of monitoring
Hypoglycemia episodes
Time frame: 28 days of monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samita Garg, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre 3 continuous glucose monitoring sensor and Nutritional drink in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Samita Garg at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samita Garg, MD (216-444-2384, gargs@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-in-Range (TIR) (time frame: 28 days of monitoring). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.