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

March 15, 2019 updated by: Gabriel Tafdrup Notkin, Nordsjaellands Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hillerod, Denmark, 3400
        • Nordsjællands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 patients with type 1 diabetes (treated with or without insulin pump) will participate in three identical test sessions on an exercise bike. During the three test sessions, patients will be monitored by heartrate, blood glucose (obtained by lancet) and CGM. The participants will also be using a diary for registration of diet as well as exercise during the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Investigators

  • Study Chair: Stig Mølsted, Post. doc., Senior Researcher

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1DM&CGM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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