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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Insulin Hypoglycemia
• Intervention / Treatment: Behavioral: "Five sessions per period" - "Two sessions per period"; Behavioral: "Two sessions per period" - "Five sessions per period"

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: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Steno Diabetes Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)	Intention-to-treat analysis (ITT).	The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)	Per protocol analysis (PP)	Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP
Percentage of time spent in the alert and clinical hypoglycemic range	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)	Study day 1: The day when the first exercise session is performed and registered.
Percentage of time spent in the alert and clinical hypoglycemic range	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)	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time spent in the alert and clinical hypoglycemic range	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)	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time spent in the alert and clinical hypoglycemic range	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)	Day time: 06:00-22:00h from during study day 1 to study day 6.
Percentage of time spent in the alert and clinical hypoglycemic range	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)	Night time: 22:00-06:00h from during study day 1 to study day 6.
Percentage of time spent in the alert and clinical hypoglycemic range	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)	The time the participant has recorded start and end of exercise session during study day 1 to study day 6
Number of alert and clinical hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of alert and clinical hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of alert and clinical hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1 - study day 6
Number of alert and clinical hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 - study day 6
Number of alert and clinical hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 study day 6
Number of severe hypoglycemia events during	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered
Number of severe hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of severe hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of severe hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1 - study day 6
Number of severe hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 - study day 6
Number of severe hypoglycemia events	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 - study day 6
Percentage of time in range (3.9-10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered
Percentage of time in range (3.9-10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time in range (3.9-10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in range (3.9-10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Percentage of time in range (3.9-10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Percentage of time in range (3.9-10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Percentage of time in good range (3.9-7.8 mmol/l)	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered.
Percentage of time in good range (3.9-7.8 mmol/l)	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time in good range (3.9-7.8 mmol/l)	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in good range (3.9-7.8 mmol/l)	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h and Night time: 22:00-06:00h during study day 1-study day 6
Percentage of time in good range (3.9-7.8 mmol/l)	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered.
Percentage of time in hyperglycemia (>10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in hyperglycemia (>10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Percentage of time in hyperglycemia (>10 mmol/l)	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l) during all the predefined time blocks. Per protocol analysis and intention-to-treat analysis	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
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	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered.
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	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
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	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
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	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
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	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Mean CGM glucose level du during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered.
Mean CGM glucose level du during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Mean CGM glucose level du during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Mean CGM glucose level du during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Mean CGM glucose level du during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Mean CGM glucose level du during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
CGM estimated eA1c during the primary intervention period	Per protocol analysis and intention-to-treat analysis	The Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Study day 1: The day when the first exercise session is performed and registered.
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period	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).	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 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	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).	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	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 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	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Actigraph wrist wear time during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Actigraph wrist wear time during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Actigraph wrist wear time during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Actigraph wrist wear time during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Actigraph wrist wear time during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Metabolic expenditure rate for the primary intervention periods	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Metabolic expenditure rate for the primary intervention periods	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Time in sedentary during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in sedentary during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Time in sedentary during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Time in sedentary during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Night time: 22:00-06:00h during study day 1 -study day 6
Time in sedentary during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Time in light physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in light physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Time in light physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Time in light physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Time in moderate physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in moderate physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Time in moderate physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Time in moderate physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Time in vigorous physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in vigorous physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Time in vigorous physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Time in vigorous physical activity during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Number of steps during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of steps during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Number of steps during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Day time: 06:00-22:00h during study day 1-study day 6
Number of steps during predefined time blocks	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Heart rate during exercise sessions	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
R-R intervals during exercise sessions (f)	Per protocol analysis and intention-to-treat analysis	Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Sleep latency (min) during the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Sleep latency (min) during the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Total sleep time (min) during the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Total sleep time (min) during the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Sleep efficiency (%) during the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Sleep efficiency (%) during the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Number of awakening during sleep in the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of awakening during sleep in the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Time of awakening during sleep in the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time of awakening during sleep in the primary and total intervention period	Per protocol analysis and intention-to-treat analysis	Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Question about patient preference regarding the two study arms	Per protocol analysis and intention-to-treat analysis	At the end of study. Study day 6 the last interventions period.

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Isabelle IK Steineck, MD, Steno Diabetes Center Copenhagen

Publications and helpful links

General 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):e001919. doi: 10.1136/bmjdrc-2020-001919.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Guidelines; Insulin pump; Diabetes Mellitus, Type 1
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: H-19035830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: 21 oktober 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No