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Pilot Clinical Evaluation: Sanvita Medical, LLC Continuous Glucose Monitoring System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205084
Recruitment Status : Active, not recruiting
First Posted : December 19, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sanvita Medical, LLC

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
Diabetes Mellitus, Insulin-Dependent Device: Sanvita OneTouch Real Time Continuous Glucose Monitoring System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Interstitial glucose values measured by Sanvita OneTouch CGM will be compared to the YSI Stat 2300 analyzer venous blood glucose. The comparison measurements are time matched.
Masking: Single (Participant)
Masking Description: Study subjects will be blinded to the values given by the Sanvita OneTouch CGM
Primary Purpose: Device Feasibility
Official Title: Pilot Clinical Evaluation: Accuracy and Precision of the Sanvita OneTouch Real Time Continuous Glucose Monitoring System
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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




Primary Outcome Measures :
  1. Accuracy of interstitial fluid continuous glucose monitoring by the Sanvita OneTouch CGM compared to YSI 2300 Analyzer [ Time Frame: 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 :
  1. Accuracy of interstitial fluid continuous glucose monitoring by the Sanvita OneTouch CGM compared between insertion sites [ Time Frame: 16 days ]
    Differences in accuracy between CGM measurements between insertion sites



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person is willing to complete study procedures.
  • Males and females ≥ 18 years.
  • Known history of Type 1 Diabetes (T1D) with a minimum of six (6) months history receiving insulin therapy.
  • 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.
  • Person agrees not to inject insulin or wear an insulin pump insertion set within 3" of abdominal CGM site.
  • Person agrees to wear a CGM on both the abdominal area and back of the upper arm.
  • Person agrees not to use the CGM glucose results for making insulin dosing or medication decisions.
  • Person is willing to participate in the study for a period of 16 days and wear the CGM sensor 24 hours each day.
  • Person is willing to visit the Study Site 4 times throughout the 16-day study.
  • Person can speak, read, write, and understand English.

Exclusion Criteria:

  • Patients with acute illness with a recent hospital admission within 30 days.
  • Cognitive disorder or other condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Female subjects who are pregnant or breast‑feeding at time of enrollment into the study.
  • Patients with measured HbA1c > 10%.
  • Patients with measured Hemoglobin < 12.0 grams.
  • History of Diabetic Ketoacidosis (DKA) in 12 months prior to study visit.
  • 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.
  • History of cardiovascular disease including but not limited to ischemic heart disease peripheral vascular disease, cardiomyopathy, congenital heart disease, or significant arrhythmias.
  • Patients that are employed by a competitive CGM manufacturer.
  • 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).
  • Patients with a known allergy to medical grade adhesives.
  • Patients on active dialysis treatment program.
  • 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.
  • Patients with hemophilia or any other bleeding disorder.
  • Patients that have an MRI scan, CT scan, or diathermy scheduled during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205084


Locations
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United States, Georgia
Atlanta Diabetes Assocaites
Atlanta, Georgia, United States, 30318
Emory Global Diabetes Research Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Sanvita Medical, LLC
Investigators
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Study Chair: Jeffrey A DuBois VIce President Medical & Scientific Affairs

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Responsible Party: Sanvita Medical, LLC
ClinicalTrials.gov Identifier: NCT04205084    
Other Study ID Numbers: SM19-CGM(P)-NA-FDA
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Sanvita Medical, LLC:
Diabetes Technology
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases