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DiaCon Overnight Closed-Loop Glucose Control Study (DiaCon2)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Closed-loop control
Open-loop control
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Glucose control, Closed-loop, Insulin pump, Glucose sensor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closed-loop glucose control

Open-loop glucose control

Arm Description

Blood glucose controlled by control algorithm.

Blood glucose controlled by patient

Outcomes

Primary Outcome Measures

Number of hypoglycemic events

Secondary Outcome Measures

Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI

Full Information

First Posted
September 28, 2011
Last Updated
November 19, 2012
Sponsor
Hvidovre University Hospital
Collaborators
Technical University of Denmark, Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01444443
Brief Title
DiaCon Overnight Closed-Loop Glucose Control Study
Acronym
DiaCon2
Official Title
DiaCon Closed-Loop Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Technical University of Denmark, Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Glucose control, Closed-loop, Insulin pump, Glucose sensor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop glucose control
Arm Type
Experimental
Arm Description
Blood glucose controlled by control algorithm.
Arm Title
Open-loop glucose control
Arm Type
Active Comparator
Arm Description
Blood glucose controlled by patient
Intervention Type
Device
Intervention Name(s)
Closed-loop control
Other Intervention Name(s)
Metronic Veo-pump. DexCom 7+ sensor.
Intervention Description
Blood glucose controlled by algorithm
Intervention Type
Other
Intervention Name(s)
Open-loop control
Intervention Description
Blood glucose controlled by patient
Primary Outcome Measure Information:
Title
Number of hypoglycemic events
Time Frame
22:00-07:00
Secondary Outcome Measure Information:
Title
Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI
Time Frame
22:00-07:00

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Schmidt, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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