Inpatient Closed-loop Glucose Control

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Hyperglycemia
• Interventions: Device: Closed-loop blood glucose control

• Registration Number: NCT01819844
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

Detailed Description

The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD \> 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (\<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.

Study Timeline

• Study First Submitted: 2013-02-28
• Study Start: 2013-03
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Results First Submitted: 2016-11-01
• Results First Submitted QC: 2017-07-20
• Results First Posted: 2017-07-21
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

• Pregnancy
• Renal insufficiency
• Cancer
• Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
• Acute illness or exacerbation of chronic illness at the time of the study procedure
• Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
• History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
• Known history of coronary artery disease, TIA or stroke
• History of seizures
• Transaminitis
• Stage 2 hypertension at the time of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed-loop blood glucose control	Closed-loop blood glucose control	Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is \> 1 u/kg or \> 2 u/kg.

Primary Outcome Measures

Name	Time	Method
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.	12 hours

Secondary Outcome Measures

Name	Time	Method
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol	12 hours
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements	12 hours
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl	12 hours
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm	12 hours
Number of BG Events < 70 mg/dl as Determined by the CGM	12 hours
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl	12 hours
Insulin Dosing (u/kg)	12 hours
Dextrose Dosing (g/kg)	12 hours
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.	12 hours	The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout

Trial Locations

Locations (1)

MGH Diabetes Research Center; 🇺🇸 Boston, Massachusetts, United States