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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time Below Range (TBR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Patients with type 1 or type 2 diabetes and gastroparesis
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.
干预措施: FreeStyle Libre 3 continuous glucose monitoring sensor (Device)
Patients with type 1 or type 2 diabetes and gastroparesis
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.
干预措施: Nutritional drink (Other)
Patients with type 1 or type 2 diabetes without gastroparesis
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
干预措施: FreeStyle Libre 3 continuous glucose monitoring sensor (Device)
Patients with type 1 or type 2 diabetes without gastroparesis
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
干预措施: Nutritional drink (Other)
结局指标
主要结局
Time Below Range (TBR)
时间窗: 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-in-Tight Range (TITR)
时间窗: 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-in-Range (TIR)
时间窗: 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.
Metrics of Glucose Variability
时间窗: 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)
Time Above Range (TAR)
时间窗: 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).
次要结局
- Hyperglycemia episodes(28 days of monitoring)
- Hypoglycemia episodes(28 days of monitoring)
研究者
Samita Garg
Principal Investigator
The Cleveland Clinic