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NCT Number: NCT04089462

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insulin Hypoglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Five sessions per period" - "Two sessions per period"

Behavioral

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)

"Two sessions per period" - "Five sessions per period"

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 13, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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