Diabetes Mellitus, Type 1NCT02942069
Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring
An observational study of Diabetes Mellitus, Type 1 and Exercise, run by Nordsjaellands Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Exercise, Continuous Glucose Monitoring
- What is being tested?
- Blood glucose measured using CGM during standardized physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Blood glucose measured using CGM during standardized physical activity
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose measured using CGM during standardized physical activityBehavioural
Standardized exercise on bicycle at 70% of the participants work capacity for ½ hour.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response measured with CGM
The participants will be tested on the research facility on a hospital in Denmark
Measured: 3 identical testing sessions throughout 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Tafdrup Notkin, Nordsjaellands Hospital
- Investigators
- Stig Mølsted, Post. doc., Study chair, Senior Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942069
- Sponsor's protocol ID
- T1DM&CGM
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2016
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT02942069
- Acronym / sponsor ID
- T1DM&CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood glucose measured using CGM during standardized physical activityStandardized exercise on bicycle at 70% of the participants work capacity for ½ hour. | Behavioural | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stig Mølsted, Post. doc. study chair
Senior Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Exercise, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response measured with CGM (time frame: 3 identical testing sessions throughout 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.