A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM) — SMA002  

Type 1 Diabetes Mellitus Clinical Trial

Official title: A Clinical Study of the Warm-Up, Accuracy, and Lag Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and displays blood sugar (glucose) levels in the body throughout the day and night. The method being used to detect blood sugar in the investigational Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by commercially available models.

Some sensors cannot tell the difference between glucose (sugar) and other substances such as Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give false readings. The GBP CGM is made to only recognize glucose in the body rather than other substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the current devices.

Clinical Trial Description

Development of accurate continuous glucose monitoring devices is critically important for the maintenance of strict glycemic control without increasing the risk for hypoglycemia and for the successful implementation of an artificial pancreas. Glucose binding protein-based (GBP) continuous glucose monitors offer several potential advantages over commercially available glucose oxidase based sensors. Unlike glucose oxidase based sensors, GBP sensors do not require establishment of an equilibrium reduction/oxidation reaction and are not as susceptible to interference from other compounds because they are engineered to recognize only glucose. As a result, GBP-based glucose sensors are exceptionally accurate at low blood glucose levels and have a faster warm-up time than glucose oxidase based systems. The principal idea of this proposal is to evaluate the accuracy and performance of a second generation glucose binding protein-based continuous glucose monitor (GBP CGM) developed by BD Technologies in subjects with type 1 diabetes, with emphasis on warm-up period after insertion, accuracy in hypoglycemic and hyperglycemic ranges, and lag time over a 24 hour period of sensor use. In order to accomplish this, the investigators will conduct a clinical trial consisting of 25.5-hour studies involving 15 subjects, each wearing one active and one mock (no GBP) device simultaneously during meals and induced hypoglycemia to observe a wide range of glucose values. The investigators envision that the glucose binding protein-based continuous glucose monitor will demonstrate minimal warm-up time after insertion, overall accuracy comparable to commercial glucose oxidase sensors with excellent performance in the hypoglycemic range and a nominal lag time to sensing a change in blood glucose. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT01469715
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Completion date: July 2012