DiaCon Overnight Closed-Loop Glucose Control Study

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Open-loop control; Device: Closed-loop control

• Registration Number: NCT01444443
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Study Start: 2011-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-19
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

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

Inclusion Criteria

• Age 18-65 years
• Type 1 diabetes duration > 2 years
• HbA1c < 8%
• Insulin pump user > 1 year

Exclusion Criteria

• Use of medication affecting glucose metabolism
• Pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Open-loop glucose control	Open-loop control	Blood glucose controlled by patient
Closed-loop glucose control	Closed-loop control	Blood glucose controlled by control algorithm.

Primary Outcome Measures

Name	Time	Method
Number of hypoglycemic events	22:00-07:00

Secondary Outcome Measures

Name	Time	Method
Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI	22:00-07:00

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark