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

Behavioral: Blood glucose measured using CGM during standardized physical activity

Study Type

Observational

Enrollment (Actual)

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

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