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Clinical Trials/NCT01444443
NCT01444443CompletedNot Applicable

DiaCon Closed-Loop Study

Hvidovre University Hospital1 site in 1 country12 target enrollmentStarted: November 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Number of hypoglycemic events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Closed-loop glucose control

Experimental

Blood glucose controlled by control algorithm.

Intervention: Closed-loop control (Device)

Open-loop glucose control

Active Comparator

Blood glucose controlled by patient

Intervention: Open-loop control (Other)

Outcomes

Primary Outcomes

Number of hypoglycemic events

Time Frame: 22:00-07:00

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Signe Schmidt

MD, Clinical research fellow

Hvidovre University Hospital

Study Sites (1)

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