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Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089462
Recruitment Status : Active, not recruiting
First Posted : September 13, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE September 5, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l) [ Time Frame: The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT) ]
Intention-to-treat analysis (ITT).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l) [ Time Frame: Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP ]
    Per protocol analysis (PP)
  • Percentage of time spent in the alert and clinical hypoglycemic range [ Time Frame: Study day 1: The day when the first exercise session is performed and registered. ]
    Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
  • Percentage of time spent in the alert and clinical hypoglycemic range [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
  • Percentage of time spent in the alert and clinical hypoglycemic range [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
  • Percentage of time spent in the alert and clinical hypoglycemic range [ Time Frame: Day time: 06:00-22:00h from during study day 1 to study day 6. ]
    Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
  • Percentage of time spent in the alert and clinical hypoglycemic range [ Time Frame: Night time: 22:00-06:00h from during study day 1 to study day 6. ]
    Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
  • Percentage of time spent in the alert and clinical hypoglycemic range [ Time Frame: The time the participant has recorded start and end of exercise session during study day 1 to study day 6 ]
    Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
  • Number of alert and clinical hypoglycemia events [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of alert and clinical hypoglycemia events [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Number of alert and clinical hypoglycemia events [ Time Frame: Day time: 06:00-22:00h during study day 1 - study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of alert and clinical hypoglycemia events [ Time Frame: Night time: 22:00-06:00h during study day 1 - study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of alert and clinical hypoglycemia events [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of severe hypoglycemia events during [ Time Frame: Study day 1: The day when the first exercise session is performed and registered ]
    Per protocol analysis and intention-to-treat analysis
  • Number of severe hypoglycemia events [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of severe hypoglycemia events [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Number of severe hypoglycemia events [ Time Frame: Day time: 06:00-22:00h during study day 1 - study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of severe hypoglycemia events [ Time Frame: Night time: 22:00-06:00h during study day 1 - study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of severe hypoglycemia events [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 - study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in range (3.9-10 mmol/l) [ Time Frame: Study day 1: The day when the first exercise session is performed and registered ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in range (3.9-10 mmol/l) [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in range (3.9-10 mmol/l) [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in range (3.9-10 mmol/l) [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in range (3.9-10 mmol/l) [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in range (3.9-10 mmol/l) [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in good range (3.9-7.8 mmol/l) [ Time Frame: Study day 1: The day when the first exercise session is performed and registered. ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in good range (3.9-7.8 mmol/l) [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in good range (3.9-7.8 mmol/l) [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in good range (3.9-7.8 mmol/l) [ Time Frame: Day time: 06:00-22:00h and Night time: 22:00-06:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in good range (3.9-7.8 mmol/l) [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in hyperglycemia (>10 mmol/l) [ Time Frame: Study day 1: The day when the first exercise session is performed and registered. ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in hyperglycemia (>10 mmol/l) [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in hyperglycemia (>10 mmol/l) [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in hyperglycemia (>10 mmol/l) [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in hyperglycemia (>10 mmol/l) [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Percentage of time in hyperglycemia (>10 mmol/l) during all the predefined time blocks. Per protocol analysis and intention-to-treat analysis [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period [ Time Frame: Study day 1: The day when the first exercise session is performed and registered. ]
    Per protocol analysis and intention-to-treat analysis
  • Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Mean CGM glucose level du during all the predefined time blocks in the intervention period [ Time Frame: Study day 1: The day when the first exercise session is performed and registered. ]
    Per protocol analysis and intention-to-treat analysis
  • Mean CGM glucose level du during all the predefined time blocks in the intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Mean CGM glucose level du during all the predefined time blocks in the intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Mean CGM glucose level du during all the predefined time blocks in the intervention period [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Mean CGM glucose level du during all the predefined time blocks in the intervention period [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Mean CGM glucose level du during all the predefined time blocks in the intervention period [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • CGM estimated eA1c during the primary intervention period [ Time Frame: The Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period [ Time Frame: Study day 1: The day when the first exercise session is performed and registered. ]
    Per protocol analysis and intention-to-treat analysis
  • Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis c) Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
  • Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis c) Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
  • Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Actigraph wrist wear time during all predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Actigraph wrist wear time during all predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Actigraph wrist wear time during all predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Actigraph wrist wear time during all predefined time blocks [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Actigraph wrist wear time during all predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Metabolic expenditure rate for the primary intervention periods [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Metabolic expenditure rate for the primary intervention periods [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time in sedentary during predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time in sedentary during predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Time in sedentary during predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in sedentary during predefined time blocks [ Time Frame: Night time: 22:00-06:00h during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in sedentary during predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in light physical activity during predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time in light physical activity during predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Time in light physical activity during predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in light physical activity during predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in moderate physical activity during predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time in moderate physical activity during predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). ]
    Per protocol analysis and intention-to-treat analysis
  • Time in moderate physical activity during predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in moderate physical activity during predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in vigorous physical activity during predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time in vigorous physical activity during predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time in vigorous physical activity during predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Time in vigorous physical activity during predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of steps during predefined time blocks [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of steps during predefined time blocks [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of steps during predefined time blocks [ Time Frame: Day time: 06:00-22:00h during study day 1-study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Number of steps during predefined time blocks [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Heart rate during exercise sessions [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • R-R intervals during exercise sessions (f) [ Time Frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6 ]
    Per protocol analysis and intention-to-treat analysis
  • Sleep latency (min) during the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Sleep latency (min) during the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Total sleep time (min) during the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Total sleep time (min) during the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Sleep efficiency (%) during the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Sleep efficiency (%) during the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of awakening during sleep in the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Number of awakening during sleep in the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time of awakening during sleep in the primary and total intervention period [ Time Frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Time of awakening during sleep in the primary and total intervention period [ Time Frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days) ]
    Per protocol analysis and intention-to-treat analysis
  • Question about patient preference regarding the two study arms [ Time Frame: At the end of study. Study day 6 the last interventions period. ]
    Per protocol analysis and intention-to-treat analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
Official Title  ICMJE Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes - A Randomized Crossover Study
Brief Summary

According to the Standards of Medical Care in Diabetes by the American Diabetes Association, people with diabetes should aim for 30 minutes of moderate-to-vigorous intensity aerobic exercise at least 5 days a week or a total of 150 minutes per week and doing some type of strength training at least 2 times per week in addition to aerobic activity. However, the effects of different forms and intervals of exercise on glycemic control are not well established. Exercise increases the risk of hypoglycemia both during and several hours after exercise.

There are several strategies to avoid hypoglycemia during exercise. The most common strategy is to reduce insulin and to take carbohydrates before the exercise starts. Short-acting insulin analogs have a duration of approximately four hours, thus reductions need to be planned and done well in advance before the exercise starts. Since different types of exercise (aerobic, strength training or high intensity training) affect blood glucose in different ways and most exercise sessions include a combination of the types, these strategies are often associated with difficulties in obtaining stable blood glucose. The American Diabetes Association guidelines do not explicitly recommend a daily workout routine but outline recommendations for weekly amounts of exercise as there is currently insufficient evidence on the ideal timing, frequency and duration of exercise for preventing hypoglycemia.

Hypothesis: in people with type 1 diabetes, time in hypoglycemia can be reduced if exercise is performed daily over five consecutive days compared to the same total amount of exercise performed at 2 days with at least 2 days interval.

Aim: to evaluate the impact of the same total amount of exercise split into either five consecutive sessions or two sessions with at least 2 days in between on percentage of time spent in hypoglycemia and other glycemic parameters in people with type 1 diabetes.

Detailed Description

The participants will go through two interventions: Exercise one session per day for five consecutive days and Exercise one session per day for two days within five days. The exercise session will start with anaerobic (push-ups, back-curls, sit-ups, triceps-dips and jumps) exercise followed by aerobic exercise (moderate intensity of running, walking or cycling). Between the two intervention periods, there will be a wash-out period.

Intervention: 'Exercise one session per day for five consecutive days'. Duration per session: Anaerobic: 4 min, Aerobic: 30 min. Sessions per intervention period: Five. Total duration per intervention period: Anaerobic: 20 min. Aerobic: 150 min. Total: 170 min

Intervention:Exercise one session per day for two days within five days. Duration per session: Anaerobe: 10 min, Aerobe: 75 min. Sessions per intervention period: 2. Total duration per intervention period: Anaerob: 20 min Aerobe: 150 min Total: 170 min

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

An open-labelled randomized controlled crossover study will be performed. The participants will go through the following elements:

  1. Screening day
  2. Run-in period
  3. Intervention period
  4. Wash-out period
  5. Intervention period
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Insulin Hypoglycemia
Intervention  ICMJE
  • Behavioral: "Five sessions per period" - "Two sessions per period"

    Period 1: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)

    Period 2: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)

  • Behavioral: "Two sessions per period" - "Five sessions per period"

    Period 1: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)

    Period 2: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)

Study Arms  ICMJE
  • 1. "Five sessions per period" - "Two sessions per period"
    Intervention: Behavioral: "Five sessions per period" - "Two sessions per period"
  • 2. "Two sessions per period" - "Five sessions per period"
    Intervention: Behavioral: "Two sessions per period" - "Five sessions per period"
Publications * Steineck IIK, Ranjan AG, Schmidt S, Norgaard K. Time spent in hypoglycemia is comparable when the same amount of exercise is performed 5 or 2 days weekly: a randomized crossover study in people with type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Jan;9(1). pii: e001919. doi: 10.1136/bmjdrc-2020-001919.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
26
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2019)
25
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 1 Diabetes ≥ 2 year
  • Insulin pump ≥ 1 year.
  • Use of carbohydrate counting and the insulin pump bolus calculator for all meals

Exclusion Criteria:

  • Use of anti-diabetic medicine (other than insulin), per oral or injected corticosteroids or other drugs affecting glucose metabolism during the intervention period or within 30 days prior to study start
  • Known or suspected alcohol or drug abuse
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
  • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • Inability to understand the participants' information and to give informed consent
  • Chronic use or unable to stop acetaminophen (paracetamol) use
  • Allergy to the patch of CGM
  • Hypoglycemia unawareness, quantified by Pedersen-Bjergaard
  • Severe hypoglycemia within the last year
  • Vigorous-intensity exercise for more than 60 minutes on 3 days or more per week
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089462
Other Study ID Numbers  ICMJE H-19035830
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data are processed and merged into at least one scientific article published in international peer-reviewed scientific journal. Positive, negative and inconclusive results will be published as soon as scientifically justifiable.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 21 oktober 2020
Responsible Party Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabelle IK Steineck, MD Steno Diabetes Center Copenhagen
PRS Account Steno Diabetes Center Copenhagen
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP