Clinical trial NCT05619198: The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems
Official title: The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities in adolescents with type 1 diabetes
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 13-17 years old
* Type 1 diabetes \> 1 year
* Use of Tandem t:slim X2 Control-IQ or Medtronic MiniMed 780G with connected continous glucose monitor \> 3 months
* HbA1c below 75 mmol/L

Exclusion Criteria:

* Use of anti-diabetic medicine other than insulin
* Breastfeeding, pregnancy or planning to become pregnant
* Lack of compliance with key study procedures at the discretion of the investigator

Primary outcomes:
measure: Percentage of time spent in sensor-derived time in range (3.9-10.0 mmol/L) during and after a bout of exercise
timeFrame: T = 0 to T = +120 (120 minutes)
Secondary outcomes:
measure: Number of hypo- (<3.9 mmol/L) and hyperglycemic (>10.0 mmol/L) occurrences during exercise session as measured by sensor and plasma sampling
timeFrame: T = 0 to T = +45 (45 minutes)
measure: 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
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: 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
timeFrame: 24 hours
measure: Glycemic variability as coefficient of variation, measured by sensor during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Glycemic variability as coefficient of variation, measured by plasma sampling during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Glycemic variability as standard deviation, measured by sensor during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Glycemic variability as standard deviation, measured by plasma sampling during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Glycemic variability as coefficient of variation measured by glucose sensor during home-phase
timeFrame: 24 hours
measure: Glycemic variability as standard deviation measured by glucose sensor during home-phase
timeFrame: 24 hours
measure: Number of rescue glucose interventions to treat hypoglycemia (<3.9 mmol/L) during in-clinic and home-phase
timeFrame: 27 hours
measure: Area Under the Curve and absolute concentration of serum total insulin during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Dynamics of plasma glucoregulatory hormone responses during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Dynamics of plasma metabolites during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Glucose changes during exercise (delta change expressed as absolute [mmol/L]) during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Glucose changes during exercise (delta change relativized as a rate of change [mmol/min]) during in-clinic phase
timeFrame: T= -60 minutes to T= +120 minutes (3 hours)
measure: Amount of correction boluses given by each automated insulin delivery system during activation of temporary target and exercise mode
timeFrame: T= -60 minutes to T= +60 minutes (2 hours)
measure: Comparison of heart rate (HR) during high intensity interval exercise and moderate intensity continous exercise session
timeFrame: T = 0 to T = +45 (45 minutes)
measure: Comparison of respiratory exchange ratio (RER) during high intensity interval exercise and moderate intensity continous exercise session
timeFrame: T = 0 to T = +45 (45 minutes)
measure: Comparison of oxygen consumption (VO2) during high intensity interval exercise and moderate intensity continous exercise session
timeFrame: T = 0 to T = +45 (45 minutes)
measure: Comparison of carbon dioxide output (VCO2) during high intensity interval exercise and moderate intensity continous exercise session
timeFrame: T = 0 to T = +45 (45 minutes)
measure: Comparison of carbohydrate oxidation during high intensity interval exercise and moderate intensity continous exercise session
timeFrame: T = 0 to T = +45 (45 minutes)
measure: Comparison of lipid oxidation during high intensity interval exercise and moderate intensity continous exercise session
timeFrame: T = 0 to T = +45 (45 minutes)
measure: Comparison of resting metabolic rate after exercise session
timeFrame: T =+45 to T=+120 (75 minutes)
measure: Plasma lactate response before, during and after cardiopulmonary exercise testing
timeFrame: 30 minutes
measure: Plasma glucose response before, during and after cardiopulmonary exercise testing
timeFrame: 30 minutes
measure: Respiratory exchange ratio (RER) collected continuously during cardiopulmonary exercise testing visit
timeFrame: 30 minutes
measure: Oxygen consumption (VO2) collected continuously during cardiopulmonary exercise testing visit
timeFrame: 30 minutes
measure: Carbon dioxide output (VCO2) collected continuously during cardiopulmonary exercise testing visit
timeFrame: 30 minutes
measure: Sleep efficiency assessed by Actigraph GT3x the night before study visits compared to after study visits.
timeFrame: Night 1-2
measure: Wake time after sleep onset assessed by Actigraph GT3x the night before study visits compared to after study visits
timeFrame: Night 1- 2
measure: Energy expenditure assessed by Actigraph GT3x.
timeFrame: Day 1-3
measure: Physical activity level assessed by Actigraph GT3x
timeFrame: Day1-3
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen, Clinical Research
name: Emilie Lindkvist, MD
role: PRINCIPAL_INVESTIGATOR
References: