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Collection of Information-Rich Type 1 Diabetes Data

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01223560
Collaborator
The Danish Council for Strategic Research (Other), Technical University of Denmark (Other), Novo Nordisk A/S (Industry)
12
Enrollment
1
Location
7
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin Aspart
  • Other: Exercise
  • Dietary Supplement: Carbohydrate
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Primary Purpose:
Prevention
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hvidovre University Hospital Hvidovre Denmark 2650

    Sponsors and Collaborators

    • Hvidovre University Hospital
    • The Danish Council for Strategic Research
    • Technical University of Denmark
    • Novo Nordisk A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01223560
    Other Study ID Numbers:
    • DiaCon Study 01
    First Posted:
    Oct 19, 2010
    Last Update Posted:
    Oct 19, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    Artificial pancreas
    Model predictive control
    Virtual patient
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Insulin Aspart

    Study Results

    No Results Posted as of Oct 19, 2010