Back to resultsCollection of Information-Rich Type 1 Diabetes Data
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Aspart
Exercise
Carbohydrate
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes focused on measuring Artificial pancreas, Model predictive control, Virtual patient
Eligibility Criteria
Inclusion Criteria:
- diabetes duration > 5 years
- HbA1c < or = 7.2%
- CSII treated for > 3 months
- Capable of being moderately, physically active for 20 minutes
Exclusion Criteria:
- symptoms of diabetic late complications except simplex retinopathy
- pregnancy or nursing
Sites / Locations
- Hvidovre University Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01223560
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
Hvidovre University Hospital
Collaborators
The Danish Council for Strategic Research, Technical University of Denmark, Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT01223560
Brief Title
Collection of Information-Rich Type 1 Diabetes Data
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
Collaborators
The Danish Council for Strategic Research, Technical University of Denmark, Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this clinical study was to obtain type 1 diabetes data to identify models for glucose prediction and control and to construct a physiological pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Artificial pancreas, Model predictive control, Virtual patient
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart
Intervention Description
Insulin bolus with and without carbohydrate intake.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise on tread mill
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate
Intervention Description
Carbohydrate intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diabetes duration > 5 years
HbA1c < or = 7.2%
CSII treated for > 3 months
Capable of being moderately, physically active for 20 minutes
Exclusion Criteria:
symptoms of diabetic late complications except simplex retinopathy
pregnancy or nursing
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Collection of Information-Rich Type 1 Diabetes Data
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