Pilot Clinical Evaluation: Sanvita Medical, LLC Continuous Glucose Monitoring System
Study Details
Study Description
Brief Summary
A Pilot clinical evaluation to study the performance of the Sanvita OneTouch Real Time Continuous Glucose Monitoring System compared to the YSI 2300 analyzer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A Pilot clinical evaluation to study the performance, accuracy and safety of the Sanvita OneTouch Real Time Continuous Glucose Monitoring System compared to the YSI 2300 analyzer. The performance data will be obtained during onsite clinical study site visits where up to 25 subjects will have glucose manipulations and glucose will be measured at predetermined intervals and the numerical data will be compared to values obtained with the YSI 2300 analyzer. The study will have three arms: hypoglycemic clamp protocol, hyperglycemic clamp protocol and a standard protocol.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Standard Protocol Subjects with type 1 diabetes, receiving treatment with insulin will be admitted at the clinical research Study Site. Two CGM devices will be inserted on each subject. The subjects will be allowed to eat meals and use their own insulin as usual, under observation, in the clinical center. Interstitial glucose values measured by CGM will be paired with the YSI 2300 blood glucose will be collected at the same time as the CGM timestamp every 15 min and analyzed. |
Device: Sanvita OneTouch Real Time Continuous Glucose Monitoring System
Sanvita OneTouch Real Time Continuous Glucose Monitoring System is an experimental glucose monitoring system that measures intersticial blood glucose and reports the glucose values in a reader
|
| Experimental: Hypoglycemic Protocol Subjects with type 1 diabetes, receiving treatment with insulin will be admitted at the clinical research Study Site. Two CGM devices will be inserted on each subject. Hypoglycemia will be induced using a hyperinsulinemic infusion and samples will be obtained at 5 - 10 min intervals. Interstitial glucose values measured by CGM will be paired with the YSI 2300 blood glucose collected at the same time as the CGM timestamp and analyzed. |
Device: Sanvita OneTouch Real Time Continuous Glucose Monitoring System
Sanvita OneTouch Real Time Continuous Glucose Monitoring System is an experimental glucose monitoring system that measures intersticial blood glucose and reports the glucose values in a reader
|
| Experimental: Hyperglycemic Protocol Subjects with type 1 diabetes, receiving treatment with insulin will be admitted at the clinical research Study Site. Two CGM devices will be inserted on each subject. Hyperglycemia will be induced using a dextrose infusion and samples will be obtained at 5 -10 min intervals. Interstitial glucose values measured by CGM will be paired with the YSI 2300 blood glucose collected at the same time as the CGM timestamp and analyzed. |
Device: Sanvita OneTouch Real Time Continuous Glucose Monitoring System
Sanvita OneTouch Real Time Continuous Glucose Monitoring System is an experimental glucose monitoring system that measures intersticial blood glucose and reports the glucose values in a reader
|
Outcome Measures
Primary Outcome Measures
- Accuracy of interstitial fluid continuous glucose monitoring by the Sanvita OneTouch CGM compared to YSI 2300 Analyzer [16 days]
The accuracy of the interstitial glucose values measured by CGM will be paired with the YSI 2300 blood glucose analysis collected at the same time as the CGM timestamp during glucose manipulations. CGM metrics will include overall mean absolute relative difference (MARD) over the full 16-day wear cycle by wear site.
Secondary Outcome Measures
- Accuracy of interstitial fluid continuous glucose monitoring by the Sanvita OneTouch CGM compared between insertion sites [16 days]
Differences in accuracy between CGM measurements between insertion sites
Eligibility Criteria
Criteria
Inclusion Criteria:
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Person is willing to complete study procedures.
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Males and females ≥ 18 years.
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Known history of Type 1 Diabetes (T1D) with a minimum of six (6) months history receiving insulin therapy.
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Subjects must have a blood glucose < 250 mg/dL and a plasma β-hydroxybutyrate < 1.0 mmol/L at time of admission to the Study Site.
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Person agrees not to inject insulin or wear an insulin pump insertion set within 3" of abdominal CGM site.
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Person agrees to wear a CGM on both the abdominal area and back of the upper arm.
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Person agrees not to use the CGM glucose results for making insulin dosing or medication decisions.
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Person is willing to participate in the study for a period of 16 days and wear the CGM sensor 24 hours each day.
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Person is willing to visit the Study Site 4 times throughout the 16-day study.
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Person can speak, read, write, and understand English.
Exclusion Criteria:
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Patients with acute illness with a recent hospital admission within 30 days.
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Cognitive disorder or other condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
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Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
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Patients with measured HbA1c > 10%.
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Patients with measured Hemoglobin < 12.0 grams.
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History of Diabetic Ketoacidosis (DKA) in 12 months prior to study visit.
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History of epilepsy, severe migraines in the last 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or history of severe hypoglycemia requiring hospitalization in the past 6 months.
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History of cardiovascular disease including but not limited to ischemic heart disease peripheral vascular disease, cardiomyopathy, congenital heart disease, or significant arrhythmias.
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Patients that are employed by a competitive CGM manufacturer.
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Patients with extensive skin change/diseases that preclude wearing the CGM Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, surgical sites).
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Patients with a known allergy to medical grade adhesives.
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Patients on active dialysis treatment program.
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Patients taking a prescription anticoagulant (such as Warfarin or Heparin) or has clotting problems that may prolong bleeding. Routinely taking Plavix or aspirin daily is not excluded.
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Patients with hemophilia or any other bleeding disorder.
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Patients that have an MRI scan, CT scan, or diathermy scheduled during the study period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlanta Diabetes Assocaites | Atlanta | Georgia | United States | 30318 |
| 2 | Emory Global Diabetes Research Center | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Sanvita Medical, LLC
Investigators
- Study Chair: Jeffrey A DuBois, VIce President Medical & Scientific Affairs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SM19-CGM(P)-NA-FDA