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NCT02942069 Clinical Trial

Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02942069
Other study ID # T1DM&CGM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date February 2019

Study information
Verified date March 2019
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this project is to investigate whether the glucose response in type 1 diabetes patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated standardized test sessions that include physical activity.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes with a diabetes duration of at least 2 years

- age 18-60 years (inclusive)

- given informed consent

- exercises (at least 30 minutes intentional exercise where participants feel exhausted) one or more times a week

- participants agree to use CGM correctly

Exclusion Criteria:

- pregnancy

- exercising at a high level (five or more times a week with high intensity)

- treatment with prednisolone or less than a month ago contestant has been treated with prednisolone

- treatment with beta blockers

- Abuse of alcohol / drugs

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Blood glucose measured using CGM during standardized physical activity
Standardized exercise on bicycle at 70% of the participants work capacity for ½ hour.

Locations
Country Name City State
Denmark Nordsjællands Hospital Hillerod

Sponsors (1)
Lead Sponsor Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood glucose response measured with CGM The participants will be tested on the research facility on a hospital in Denmark 3 identical testing sessions throughout 3 weeks
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