Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents

Status Completed

Clinical Trial Summary

Clinical Trial Description

The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels when an insulin bolus is omitted for a 30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of carbohydrates consumed for a meal. The CTR system is comprised of two algorithmic layers: (i) A Safety Supervision Module (SSM) which contains a predictive insulin request dampener (or brakes); (ii) a Range Correction Module (RCM), consisting in (a) a Hyperglycemia Mitigation System, and (b) Insulin on Board controller. Both modules will receive continuous glucose monitoring (CGM) and historical insulin delivery data. The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The RCM will be responsible for optimizing blood glucose (BG) control and mitigating postprandial hyperglycemic excursions through a mix of increased basal rate and, potentially, isolated insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant) which consists of a smart phone running CTR and connected to standard insulin delivery and CGM devices. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01890954
Study type	Interventional
Source	University of Virginia
Contact
Status	Completed
Phase	N/A
Start date	August 2013
Completion date	February 2014

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.