An interventional study of High Intensity Interval Exercise and Moderate Intensity Continous Exercise in Type 1 Diabetes, sponsored by Steno Diabetes Center Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Prevention
Objective:
The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin delivery (AID) systems (MiniMed 780G and Tandem Control-IQ).
Methods:
This study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with T1D (12 using MiniMed 780G and 12 using Tandem Control-IQ).
Endpoint:
The primary endpoint is sensor-derived time in range (3.9 mmol/L-10.0 mmol/L) around exercise
Participants included in the study will perform a cardiopulmonary exercise testing (CPET) before the exercise study visits, to prescribe subsequent exercise intensity thresholds. Participants will have a canula placed in a antecubital vein for plasma sampling during the test.
Participants will undertake two exercise visits each including a bout of exercise on a stationary bicycle of either one of two exercise modalities; i.) high-intensity interval exercise with sprints at \~85% of VO2max (HIIE); ii.) moderate intensity continuous exercise at \~60% of VO2max (MICE).
Participants will arrive at the research facility, Steno Diabetes Center Copenhagen, in the afternoon. As per the current recommended guidelines, the MICE-session will be announced to the AID systems 60 minutes in advance, whereas the HIIE-session will not be announced. Participants will have a canula placed in a antecubital vein for plasma sampling.
Participants will rest for 60 minutes, exercise for 45 minutes and rest again for 75 minutes before leaving the research facility. During exercise participants will be fitted with a spirometry face mask to compute ventilatory thresholds and indirect calorimetry (Vyaire Vyntus® CPX, Intramedic A/S) and a telemetry chest strap (Polar H10) for integrated HR heart rate (HR) measurements with the spirometry device.
In the MICE session: After 15 minutes post-exercise rest the temporary target/exercise mode is turned off.
Around each study visit (24 hours prior until 24 hours after), sensor glucose as well as sleep and physical activity will be recorded. Sensor glucose will be measured by participants' own devices. Sleep and physical activity level will be assessed with a wrist-worn accelerometer, ActiGraph wGT3X-BT (ActiGraph, Pensacola, FL).
Study days will be separated by at least three days.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Plasma and sensor glucose is monitored before, during and after a bout of high intensity interval exercise
Behavioral: High Intensity Interval Exercise
Plasma and sensor glucose is monitored before, during and after a bout of moderate intensity continous exercise
Behavioral: Moderate Intensity Continous Exercise
High Intensity Interval Exercise: * 5 minutes resting phase @ 0 watts. * 5-minute warm up phase @ 20 watts. * 40 minutes of interval work consisting of eight bouts of 1-minute cycling at a power output corresponding to \~85% of VO2max interspersed with 4-minute recovery periods at 20 watts. * 5 minutes resting phase @ 0 watts.
Moderate Intensity Continous Exercise: * 5 minutes resting phase @ 0 watts. * 5-minute warm up phase @ 20 watts. * 40 minutes of MICE 65% VO2max. * 5 minutes resting phase @ 0 watts.
Percentage of time spent in sensor-derived time in range (3.9-10.0 mmol/L) during and after a bout of exercise
Percentage
Time frame: T = 0 to T = +120 (120 minutes)
Number of hypo- (<3.9 mmol/L) and hyperglycemic (>10.0 mmol/L) occurrences during exercise session as measured by sensor and plasma sampling
Number
Time frame: T = 0 to T = +45 (45 minutes)
Percentage of time spent below (<3.9 mmol/L), in (3.9-10.0 mmol/L) and above (>10.0 mmol/L) range during in-clinic phase, measured by sensor and plasma sampling
Percentage
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Percentage of time spent below (<3.9 mmol/L), in (3.9-10.0 mmol/L) and above (>10.0 mmol/L) range during home-phase, measured by glucose sensor
Percentage
Time frame: 24 hours
Glycemic variability as coefficient of variation, measured by sensor during in-clinic phase
Percentage
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Glycemic variability as coefficient of variation, measured by plasma sampling during in-clinic phase
Percentage
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Glycemic variability as standard deviation, measured by sensor during in-clinic phase
mmol/L
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Glycemic variability as standard deviation, measured by plasma sampling during in-clinic phase
mmol/L
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Glycemic variability as coefficient of variation measured by glucose sensor during home-phase
Percentage
Time frame: 24 hours
Glycemic variability as standard deviation measured by glucose sensor during home-phase
Mmol/L
Time frame: 24 hours
Number of rescue glucose interventions to treat hypoglycemia (<3.9 mmol/L) during in-clinic and home-phase
Number
Time frame: 27 hours
Area Under the Curve and absolute concentration of serum total insulin during in-clinic phase
Units
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Dynamics of plasma glucoregulatory hormone responses during in-clinic phase
Change in concentration
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Dynamics of plasma metabolites during in-clinic phase
Change in concentration
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Glucose changes during exercise (delta change expressed as absolute [mmol/L]) during in-clinic phase
mmol/L
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Glucose changes during exercise (delta change relativized as a rate of change [mmol/min]) during in-clinic phase
mmol/min
Time frame: T= -60 minutes to T= +120 minutes (3 hours)
Amount of correction boluses given by each automated insulin delivery system during activation of temporary target and exercise mode
Number
Time frame: T= -60 minutes to T= +60 minutes (2 hours)
Comparison of heart rate (HR) during high intensity interval exercise and moderate intensity continous exercise session
Beats pr minute
Time frame: T = 0 to T = +45 (45 minutes)
Comparison of respiratory exchange ratio (RER) during high intensity interval exercise and moderate intensity continous exercise session
Ratio
Time frame: T = 0 to T = +45 (45 minutes)
Comparison of oxygen consumption (VO2) during high intensity interval exercise and moderate intensity continous exercise session
L/min
Time frame: T = 0 to T = +45 (45 minutes)
Comparison of carbon dioxide output (VCO2) during high intensity interval exercise and moderate intensity continous exercise session
L/min
Time frame: T = 0 to T = +45 (45 minutes)
Comparison of carbohydrate oxidation during high intensity interval exercise and moderate intensity continous exercise session
g/min
Time frame: T = 0 to T = +45 (45 minutes)
Comparison of lipid oxidation during high intensity interval exercise and moderate intensity continous exercise session
g/min
Time frame: T = 0 to T = +45 (45 minutes)
Comparison of resting metabolic rate after exercise session
kj/min
Time frame: T =+45 to T=+120 (75 minutes)
Plasma lactate response before, during and after cardiopulmonary exercise testing
mmol/L
Time frame: 30 minutes
Plasma glucose response before, during and after cardiopulmonary exercise testing
mmol/L
Time frame: 30 minutes
Respiratory exchange ratio (RER) collected continuously during cardiopulmonary exercise testing visit
L/min
Time frame: 30 minutes
Oxygen consumption (VO2) collected continuously during cardiopulmonary exercise testing visit
L/min
Time frame: 30 minutes
Carbon dioxide output (VCO2) collected continuously during cardiopulmonary exercise testing visit
L/min
Time frame: 30 minutes
Sleep efficiency assessed by Actigraph GT3x the night before study visits compared to after study visits.
Percentage
Time frame: Night 1-2
Wake time after sleep onset assessed by Actigraph GT3x the night before study visits compared to after study visits
Mins
Time frame: Night 1- 2
Energy expenditure assessed by Actigraph GT3x.
Kcal
Time frame: Day 1-3
Physical activity level assessed by Actigraph GT3x
sedentary, light or moderate-to-vigorous
Time frame: Day1-3
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Steno Diabetes Center Copenhagen