Type1 Diabetes MellitusNCT03034798
Suspending Basal Insulin Levels for Exercise in Adults With Type 1 Diabetes
An observational study of Type1 Diabetes Mellitus and Physical Activity, run by York University.
Trial summary
The purpose of the study is to determine the effects of insulin suspension at start of exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this project. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type1 Diabetes Mellitus, Physical Activity, Hypoglycemia
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2015to 28 Jul 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants were recruited by random sampling as well as an email blast using previous studies that involved individuals with type 1 diabetes on insulin pump therapy and regularly active. The previous research project at York University had the same inclusion criteria, so that email list will be used to contact those individuals for this study as well.
Who may be able to join
- Have had diabetes for > 1 year
- Currently treated with continuous subcutaneous insulin infusion (CSII)/insulin pump therapy for at least 6 months
- Fair-to-good glycemic control (last HbA1c ≤ 9.0%)
Who cannot join
- Frequent and unpredictable hypoglycemia
- Unable to exercise on a regular basis due to an injury or other restriction
- Using an insulin pump and switch to injections (or vice versa) in the last two months
- Have conditions that would make exercise unsafe (e.g. high blood pressure)
- Take medications in the class of drugs called 'beta-blockers'
- A woman who is pregnant, planning pregnancy, or breastfeeding
About this study
Official title: The Effects of Basal Insulin Suspension at the Start of Exercise on Blood Glucose Levels During Continuous vs. Circuit-based Exercise in Individuals With Type 1 Diabetes on CSII
The purpose of the study is to determine the effects of insulin suspension at start of exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this project. The first will be a familiarization session that requires completed informed consent, anthropometric measurements (height, weight, body fat percentage), questionnaires, and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic exercise as well as circuit exercise.
Read the detailed description
Written informed consent will be collected on the first day during the familiarization session from all individuals that wish to participate. A researcher will provide a brief explanation on how the continuous glucose monitor (CGM) works (Medtronic Inc., Canada) during the first visit to the laboratory. They will also describe how the CGM sensor insertion process will occur for those participants who have not worn one in the past. The participant will clean and sanitize the area and insert the CGM superficially in the skin themselves and connect the transmitter device to the sensor. The CGM will be worn for a total of 7 days and then removed by the participant and returned to the researcher to be downloaded. The sports armband will also be placed on the left upper arm and be worn continuously for 7 days. The principal student investigator (PSI) or principal investigator (PI) will provide all participants with information about the sports armband and place it on the skin immediately following. This device simply sits on the surface of the skin, but has a specific placement and activation and must be applied by the PSI or PI. Finally, during exercise visits, the Zephyr bioharness will be connected just below chest level and around the rib cage. This device is sits on top of the skin simply like an elastic band around the rib cage. The bioharness will only be worn during exercise visits and disconnected at the end of each activity.
Blood glucose levels will be monitored frequently during exercise using a Contour Link glucometer (Bayer, Canada). Participants will use personal lancing device for finger pokes, but the investigators will provide the glucometer and test strips. Each blood sugar check will be recorded in the data binder along with carbohydrate intake, any changes in basal rate or pump settings, and food intake. If blood glucose levels reach 3.9 mmol/L or less, participants will be asked to stop activity immediately and consume fast-acting carbohydrates (i.e. Dextrose tablets (Dex4, USA)). 15-minutes after ingestion of carbohydrates, blood glucose will be tested again before allowing the individual to return to activity safely. On the last day of testing, participants will be asked to return the CGM, sports armband, and bioharness to the research team. The data will later be uploaded and analyzed.
Patients will undergo a fitness assessment (maximal aerobic capacity) during visit 1 and perform 40-minutes of continuous (treadmill jogging) and 40-minutes of intermittent (calisthenics) high-intensity type exercises (visit 2 and 3). Upon entry to the laboratory, participants will be asked to check blood glucose levels using the glucometer provided. The first exercise session will consist of a 40-minute treadmill walk/jog at ~40-50% of VO2max. The second exercise session will include various aerobic and anaerobic activities including push-ups, plank, jumping jacks, high knees, etc. Regular finger capillary blood samples will be collected every 10-minutes during exercise. Once the exercise session is complete, participants will be asked to remain in the laboratory for 30-minutes for additional blood glucose measurements and to ensure hypoglycemic episodes do not occur post-exercise. Participants will be given the contour link glucometer to monitor glucose levels throughout the evening and night.
- Conditions
- Type1 Diabetes Mellitus, Physical Activity, Hypoglycemia
- Medical subject headings
- Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes Exercisers | Participants performed 2 different forms of exercise of identical duration and similar total energy expenditure. One form was purely aerobic in nature and the other was intermittent, high-intensity exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentrations
Whole blood glucose concentrations were measured using a handheld glucometer every 10-minutes before, during, and after both exercise conditions.
Measured: Approximately 2 hours
Secondary outcomes (1)
Participants estimated blood glucose concentration
Whole blood glucose concentrations were measured using a handheld glucometer and the values were blinded from participants during exercise. Participants were asked to estimate the change in glycemia every 10-minutes and actual measured blood glucose was revealed to participants post-exercise.
Measured: 40-minutes during exercise and 10-minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start14 Jan 2015
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type1 Diabetes MellitusStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Illinois Institute of Technology
- Responsible party
- Principal investigator, Michael Riddell, York University
- Investigators
- Michael C Riddell, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034798
- Sponsor's protocol ID
- 1DP3DK101075
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabet Med. 2011 Jul;28(7):824-32. doi: 10.1111/j.1464-5491.2011.03274.x.
PubMed 21388440Guelfi KJ, Ratnam N, Smythe GA, Jones TW, Fournier PA. Effect of intermittent high-intensity compared with continuous moderate exercise on glucose production and utilization in individuals with type 1 diabetes. Am J Physiol Endocrinol Metab. 2007 Mar;292(3):E865-70. doi: 10.1152/ajpendo.00533.2006.
PubMed 17339500Yardley JE, Sigal RJ. Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. Diabetes Spectr. 2015 Jan;28(1):32-8. doi: 10.2337/diaspect.28.1.32.
PubMed 25717276
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Basal Insulin Suspension at the Start of Exercise on Blood Glucose Levels During Continuous vs. Circuit-based Exercise in Individuals With Type 1 Diabetes on CSII
- ClinicalTrials.gov ID
- NCT03034798
- Acronym / sponsor ID
- 1DP3DK101075
- Conditions
- Type1 Diabetes Mellitus, Physical Activity, Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Illinois Institute of Technology
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 27 Jan 2017 (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 the study is to determine the effects of insulin suspension at start of exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this project. The first will be a familiarization session that requires completed informed consent, anthropometric measurements (height, weight, body fat percentage), questionnaires, and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic exercise as well as circuit exercise.
Detailed description
Written informed consent will be collected on the first day during the familiarization session from all individuals that wish to participate. A researcher will provide a brief explanation on how the continuous glucose monitor (CGM) works (Medtronic Inc., Canada) during the first visit to the laboratory. They will also describe how the CGM sensor insertion process will occur for those participants who have not worn one in the past. The participant will clean and sanitize the area and insert the CGM superficially in the skin themselves and connect the transmitter device to the sensor. The CGM will be worn for a total of 7 days and then removed by the participant and returned to the researcher to be downloaded. The sports armband will also be placed on the left upper arm and be worn continuously for 7 days. The principal student investigator (PSI) or principal investigator (PI) will provide all participants with information about the sports armband and place it on the skin immediately following. This device simply sits on the surface of the skin, but has a specific placement and activation and must be applied by the PSI or PI. Finally, during exercise visits, the Zephyr bioharness will be connected just below chest level and around the rib cage. This device is sits on top of the skin simply like an elastic band around the rib cage. The bioharness will only be worn during exercise visits and disconnected at the end of each activity.
Blood glucose levels will be monitored frequently during exercise using a Contour Link glucometer (Bayer, Canada). Participants will use personal lancing device for finger pokes, but the investigators will provide the glucometer and test strips. Each blood sugar check will be recorded in the data binder along with carbohydrate intake, any changes in basal rate or pump settings, and food intake. If blood glucose levels reach 3.9 mmol/L or less, participants will be asked to stop activity immediately and consume fast-acting carbohydrates (i.e. Dextrose tablets (Dex4, USA)). 15-minutes after ingestion of carbohydrates, blood glucose will be tested again before allowing the individual to return to activity safely. On the last day of testing, participants will be asked to return the CGM, sports armband, and bioharness to the research team. The data will later be uploaded and analyzed.
Patients will undergo a fitness assessment (maximal aerobic capacity) during visit 1 and perform 40-minutes of continuous (treadmill jogging) and 40-minutes of intermittent (calisthenics) high-intensity type exercises (visit 2 and 3). Upon entry to the laboratory, participants will be asked to check blood glucose levels using the glucometer provided. The first exercise session will consist of a 40-minute treadmill walk/jog at ~40-50% of VO2max. The second exercise session will include various aerobic and anaerobic activities including push-ups, plank, jumping jacks, high knees, etc. Regular finger capillary blood samples will be collected every 10-minutes during exercise. Once the exercise session is complete, participants will be asked to remain in the laboratory for 30-minutes for additional blood glucose measurements and to ensure hypoglycemic episodes do not occur post-exercise. Participants will be given the contour link glucometer to monitor glucose levels throughout the evening and night.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Exercisers | – | –Participants performed 2 different forms of exercise of identical duration and similar total energy expenditure. One form was purely aerobic in nature and the other was intermittent, high-intensity exercise. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants were recruited by random sampling as well as an email blast using previous studies that involved individuals with type 1 diabetes on insulin pump therapy and regularly active. The previous research project at York University had the same inclusion criteria, so that email list will be used to contact those individuals for this study as well.
Key inclusion criteria (3 listed)
- Have had diabetes for > 1 year
- Currently treated with continuous subcutaneous insulin infusion (CSII)/insulin pump therapy for at least 6 months
- Fair-to-good glycemic control (last HbA1c ≤ 9.0%)
Key exclusion criteria (6 listed)
- Frequent and unpredictable hypoglycemia
- Unable to exercise on a regular basis due to an injury or other restriction
- Using an insulin pump and switch to injections (or vice versa) in the last two months
- Have conditions that would make exercise unsafe (e.g. high blood pressure)
- Take medications in the class of drugs called 'beta-blockers'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood glucose concentrations
Time frame: Approximately 2 hours
Whole blood glucose concentrations were measured using a handheld glucometer every 10-minutes before, during, and after both exercise conditions.
1 secondary outcome
Participants estimated blood glucose concentration
Time frame: 40-minutes during exercise and 10-minutes post-exercise
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 27 Jan 2017.
- Results publication: PubMed 21388440Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabet Med. 2011 Jul;28(7):824-32. doi: 10.1111/j.1464-5491.2011.03274.x.
- Results publication: PubMed 17339500Guelfi KJ, Ratnam N, Smythe GA, Jones TW, Fournier PA. Effect of intermittent high-intensity compared with continuous moderate exercise on glucose production and utilization in individuals with type 1 diabetes. Am J Physiol Endocrinol Metab. 2007 Mar;292(3):E865-70. doi: 10.1152/ajpendo.00533.2006.
- Results publication: PubMed 25717276Yardley JE, Sigal RJ. Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. Diabetes Spectr. 2015 Jan;28(1):32-8. doi: 10.2337/diaspect.28.1.32.
- Individual participant dataSharing planned: No
Related trials for Type1 Diabetes Mellitus
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
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.
Michael C Riddell, PhD principal investigator
York University
Questions about this trial
What is this clinical trial studying?
An observational study of Type1 Diabetes Mellitus and Physical Activity, run by York University.
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 3 inclusion and 6 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 27 Jan 2017. 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?
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 concentrations (time frame: Approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034798, which also lists 3 linked publications.
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 27 Jan 2017.