CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Heart rate informed SSM+HMMdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01582139
NCT01582139N/ACompleted
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Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker

University of Virginia·interventional·Posted Apr 20, 2012·Updated Aug 15, 2014

In Brief

A clinical study evaluating Heart rate informed SSM+HMM for Type 1 Diabetes Mellitus. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if information about heart rate can help the AP Platform reduce hypoglycemia related to exercise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc., Insulet Corporation, Abbott Diabetes Care

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartMay 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.2 years ago

Interventions

Heart rate informed SSM+HMMdevice

The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.