Type 1 DiabetesGLYSPORTNCT05357534
Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
A study testing Physical activity in people with Type 1 Diabetes, run by Université de Reims Champagne-Ardenne.
Trial summary
Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Feb 2023
- Phase
- Interventional
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 diabetics diagnosed more than 3 years ago and controlled (an HbA1c of less than 8%) for "type 1 diabetes" group
- without diabetes for "healkthy" group
- Male
- Aged 18 to 65
- Body Mass Index less than 30 kg/m2
- regular running (at least 30 minutes per week and at least one 10-km run per year for the previous 2 years)
- Agreeing to participate in the study
Who cannot join
- Physical injury
- beta blockers treatment
Trial locations and contacts
No sites are listed yet.
About this study
Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity.
Sports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. However, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia.
Moreover, hypoglycemia and hyperglycemia will impact body functions. Perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.
Read the detailed description
The aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity
- Conditions
- Type 1 Diabetes
- Being tested
- Physical activity
- Keywords
- Type 1 Diabetes, blood sugar variations, 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.
Physical activityOther
Physical activity: 10 km run on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| "Type 1 diabetes" group | Experimental | "type 1 diabetes" group: patients with type 1 diabetes Receives: Other: Physical activity |
| "healthy" group | Active comparator | "healthy" group : subjects without type 1 diabetes Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar
Blood sugar evaluated in g/L via continuous blood glucose measurement
Measured: Day 0
Feeling lucidity
Lucidity, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "not at all lucid" to "completely lucid"
Measured: Day 0
Feeling fatigue
hydratation, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of dehydration" to "dehydrated"
Measured: Day 0
feeling hungry
hungry, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of hunger" to "hungry"
Measured: Day 0
average speed per kilometer Sports performance
Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill
Measured: Day 0
total running time
Sports performance evaluated by total running time of the 10 km run on a treadmill
Measured: Day 0
average running speed
Sports performance evaluated by average running speed of the 10 km run on a treadmill
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357534
- Sponsor's protocol ID
- 2022-RIPH_002_GLYSPORT
- Acronym
- GLYSPORT
- Status last verified
- May 2022
- First submitted
- 21 Mar 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05357534
- Acronym / sponsor ID
- GLYSPORT / 2022-RIPH_002_GLYSPORT
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, blood sugar variations, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 3 May 2022 (actual)
- 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.
Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity.
Sports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. However, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia.
Moreover, hypoglycemia and hyperglycemia will impact body functions. Perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.
Detailed description
The aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Type 1 diabetes" group | Experimental | Other: Physical activity"type 1 diabetes" group: patients with type 1 diabetes |
| "healthy" group | Active comparator | Other: Physical activity"healthy" group : subjects without type 1 diabetes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 1 diabetics diagnosed more than 3 years ago and controlled (an HbA1c of less than 8%) for "type 1 diabetes" group
- without diabetes for "healkthy" group
- Male
- Aged 18 to 65
- Body Mass Index less than 30 kg/m2
Key exclusion criteria (2 listed)
- Physical injury
- beta blockers treatment
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 |
|---|---|---|
| Physical activityPhysical activity: 10 km run on a treadmill | Other | "Type 1 diabetes" group, "healthy" group |
Primary outcome
blood sugar
Time frame: Day 0
Blood sugar evaluated in g/L via continuous blood glucose measurement
Feeling lucidity
Time frame: Day 0
Lucidity, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "not at all lucid" to "completely lucid"
Feeling fatigue
Time frame: Day 0
hydratation, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of dehydration" to "dehydrated"
feeling hungry
Time frame: Day 0
hungry, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of hunger" to "hungry"
average speed per kilometer Sports performance
Time frame: Day 0
Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill
total running time
Time frame: Day 0
Sports performance evaluated by total running time of the 10 km run on a treadmill
average running speed
Time frame: Day 0
Sports performance evaluated by average running speed of the 10 km run on a treadmill
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Type 1 Diabetes, run by Université de Reims Champagne-Ardenne.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe JOLY, MCU-HDR (0326918822 ext. +33, philippe.joly@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sugar (time frame: Day 0). The study lists 7 primary outcomes in all. 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 May 2022.