Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089462
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Insulin Hypoglycemia Behavioral: "Five sessions per period" - "Two sessions per period" Behavioral: "Two sessions per period" - "Five sessions per period" Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Official Title: Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes - A Randomized Crossover Study
Estimated Study Start Date : September 9, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1. "Five sessions per period" - "Two sessions per period" 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)


2. "Two sessions per period" - "Five sessions per period" 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)





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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).

  55. 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).

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. 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

  70. 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

  71. 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

  72. 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

  73. 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

  74. 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

  75. 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

  76. 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

  77. 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

  78. 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

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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

  99. 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

  100. 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

  101. 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

  102. 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

  103. 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

  104. 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

  105. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 Diabetes ≥ 2 year
  • Insulin pump ≥ 1 year.
  • Use of carbohydrate counting and the insulin pump bolus calculator for all meals
  • Low and Moderate physical activity level measured by the International Physical Activity-short version.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089462


Contacts
Layout table for location contacts
Contact: Isabelle IK Steineck, MD +4540358398 Isabelle.Isa.Kristin.Steineck.01@regionh.dk
Contact: Kirsten Nørgaard, MD, DMSc, MHPE +4527131011 Kirsten.Noergaard@regionh.dk

Locations
Layout table for location information
Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Isabelle IK Steineck, MD    +45 40358398    Isabelle.Isa.Kristin.Steineck.01@regionh.dk   
Contact: Kirsten Nørgaard, MD PhD       Kirsten.Noergaard@regionh.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Isabelle IK Steineck, MD Steno Diabetes Center Copenhagen

Layout table for additonal information
Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04089462     History of Changes
Other Study ID Numbers: H-19035830
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Time Frame: 21 oktober 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steno Diabetes Center Copenhagen:
Exercise
Insulin pump
Diabetes Mellitus, Type 1
Guidelines
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases