Collection of Information-Rich Type 1 Diabetes Data

Type 1 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223560
• Other study ID #: DiaCon Study 01
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin Aspart
Insulin bolus with and without carbohydrate intake.

Other:
• Exercise
Exercise on tread mill

Dietary Supplement:
• Carbohydrate
Carbohydrate intake

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (4)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Novo Nordisk A/S, Technical University of Denmark, The Danish Council for Strategic Research

Country where clinical trial is conducted

Denmark,