An interventional study of Exercise 1 and Exercise 2 in Type 1 Diabetes Mellitus, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 2 sites in Canada. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment
Among 15 studies in Diabetes Mellitus, Type 1 by McGill University Health Centre/Research Institute of the McGill University Health Centre — 7 open to participants now, 7 under way, 5 of them phase 3. Diabetes Mellitus, Type 1 · McGill University Health Centre/Research Institute of the McGill University Health Centre.
Among the 15 studies in Diabetes Mellitus, Type 1 by McGill University Health Centre/Research Institute of the McGill University Health Centre, this one is the 10th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2018, is one of 4 with no phase, and was the 2nd registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →7 of the 15 studies in Diabetes Mellitus, Type 1 by McGill University Health Centre/Research Institute of the McGill University Health Centre are open now, in 2 countries. Recruiting first, the newest first:
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada, Switzerland
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
By country, each count listing its studies:
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 14 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 6 · Phase 3 6 · Phase 4 1
First in 2016; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 20 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 32 across the 12 interventional studies, 380 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
2 of the studies in Diabetes Mellitus, Type 1 by McGill University Health Centre/Research Institute of the McGill University Health Centre that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06894784Phase 3McGill University Health Centre/Research Institute of the McGill University Health CentreA Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes | 2027-01 |
| NCT06387199Phase 3McGill University Health Centre/Research Institute of the McGill University Health CentreAlleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide | 2027-01 |
Among the 15 studies in Diabetes Mellitus, Type 1 by McGill University Health Centre/Research Institute of the McGill University Health Centre, from their registry updates:
This tab as a report to print or save as PDF → With an account.
It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 minutes prior to exercise.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Exercise 2 · Device: Dexcom G4 Platinum · Drug: Insulin · Device: Insulin pump
Other: Exercise 1 · Device: Dexcom G4 Platinum · Drug: Insulin · Device: Insulin pump
Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
The Dexcom G4 Platinum will be used to measure continuous glucose levels.
Participant's usual fast-acting insulin analog will be used.
Participant's insulin pump will be used to infuse insulin.
Decrease in glucose levels
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise
Time frame: 60 minutes (exercise period)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: 60 minutes (exercise period)
Decremental area under the curve of glucose levels
Time frame: 60 minutes (exercise period)
Area under the curve of glucose levels < 4 mmol/L
Time frame: 60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time frame: 60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time frame: 60 minutes (exercise period)
Number of patients requiring an oral treatment for hypoglycemia
Time frame: 60 minutes (exercise period)
Total number of hypoglycemia episodes requiring treatment
Time frame: 60 minutes (exercise period)
Percentage of time of glucose levels spent > 10 mmol/L
Time frame: 60 minutes (exercise period)
Percentage of time of glucose levels spent between 4-10 mmol/L
Time frame: 60 minutes (exercise period)
Mean time (minutes) to the first hypoglycemic event
Time frame: 60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event
Time frame: 60 minutes (exercise period)
Muscle blood flow
Time frame: 60 minutes (exercise period)
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Time frame: 4 hours following end of exercise
Percentage of time of glucose levels spent < 4 mmol/L
Time frame: 4 hours following end of exercise
Percentage of time of glucose levels spent > 10 mmol/L
Time frame: 4 hours following end of exercise
Area under the curve of glucose levels < 4 mmol/L
Time frame: 4 hours following end of exercise
Number of patients requiring an oral treatment for hypoglycemia
Time frame: 4 hours following end of exercise
Total number of hypoglycemia episodes requiring treatment
Time frame: 4 hours following end of exercise
Total amount of carbohydrates needed to treat hypoglycemic events
Time frame: 4 hours following end of exercise
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent < 4 mmol/L
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent > 10 mmol/L
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Area under the curve of glucose levels < 4 mmol/L
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Number of patients requiring an oral treatment for hypoglycemia
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Total number of hypoglycemia episodes requiring treatment
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Total amount of carbohydrates needed to treat hypoglycemic events
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Started May 2018 (actual). Primary completion is estimated for Jan 2019, 8 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 8 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →