Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Quebec
-
Montreal, Quebec, Kanada
- Institut de recherches cliniques de Montréal
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Active Comparator: Full snack given before exercise
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
|
Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
|
|
Active Comparator: Distributed snack over exercise period
A snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
|
Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Aikaikkuna: This outcome will be measured over 120 minutes
|
This time frame corresponds to the exercise period and the 1 hour following it
|
This outcome will be measured over 120 minutes
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
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Decrease in glucose levels
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
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Increase in glucose level
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
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Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Number of participants requiring an oral treatment for hypoglycemia
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
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Total number of hypoglycemia episodes requiring treatment
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
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Mean time (minutes) to the first hypoglycemic event
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes)
|
This outcome will be measured for the exercise period only (60 minutes)
|
|
|
Mean glucose levels
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Standard deviation of glucose levels
Aikaikkuna: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Aikaikkuna: From the end of the exercise period to dinner time.
|
Dinner time will be up to the patient.
|
From the end of the exercise period to dinner time.
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Aikaikkuna: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Aikaikkuna: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Aikaikkuna: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Aikaikkuna: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient.
|
From the end of the exercise period to dinner time
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Aikaikkuna: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Aikaikkuna: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Aikaikkuna: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Aikaikkuna: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Aikaikkuna: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Aikaikkuna: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Aikaikkuna: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Aikaikkuna: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Number of participants requiring treatment for hypoglycemia
Aikaikkuna: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Aikaikkuna: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Aikaikkuna: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Aikaikkuna: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Number of hypoglycemic episodes requiring treatment
Aikaikkuna: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Aikaikkuna: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Aikaikkuna: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Mean glucose levels
Aikaikkuna: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Mean glucose levels
Aikaikkuna: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Mean glucose levels
Aikaikkuna: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Mean glucose levels
Aikaikkuna: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
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