The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems

Type 1 Diabetes Clinical Trial

— MODE2022  

Official title:

The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619198
• Other study ID #: MODE2022
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: November 2024

Study information

• Verified date: November 2022
• Source: Steno Diabetes Center Copenhagen
• Contact: Emilie Lindkvist, MD
• Phone: +45 20187762
• Email: emilie.lindkvist[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• High Intensity Interval 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
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.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent in sensor-derived time in range (3.9-10.0 mmol/L) during and after a bout of exercise	Percentage	T = 0 to T = +120 (120 minutes)
Secondary	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	T = 0 to T = +45 (45 minutes)
Secondary	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	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	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	24 hours
Secondary	Glycemic variability as coefficient of variation, measured by sensor during in-clinic phase	Percentage	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Glycemic variability as coefficient of variation, measured by plasma sampling during in-clinic phase	Percentage	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Glycemic variability as standard deviation, measured by sensor during in-clinic phase	mmol/L	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Glycemic variability as standard deviation, measured by plasma sampling during in-clinic phase	mmol/L	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Glycemic variability as coefficient of variation measured by glucose sensor during home-phase	Percentage	24 hours
Secondary	Glycemic variability as standard deviation measured by glucose sensor during home-phase	Mmol/L	24 hours
Secondary	Number of rescue glucose interventions to treat hypoglycemia (<3.9 mmol/L) during in-clinic and home-phase	Number	27 hours
Secondary	Area Under the Curve and absolute concentration of serum total insulin during in-clinic phase	Units	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Dynamics of plasma glucoregulatory hormone responses during in-clinic phase	Change in concentration	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Dynamics of plasma metabolites during in-clinic phase	Change in concentration	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Glucose changes during exercise (delta change expressed as absolute [mmol/L]) during in-clinic phase	mmol/L	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Glucose changes during exercise (delta change relativized as a rate of change [mmol/min]) during in-clinic phase	mmol/min	T= -60 minutes to T= +120 minutes (3 hours)
Secondary	Amount of correction boluses given by each automated insulin delivery system during activation of temporary target and exercise mode	Number	T= -60 minutes to T= +60 minutes (2 hours)
Secondary	Comparison of heart rate (HR) during high intensity interval exercise and moderate intensity continous exercise session	Beats pr minute	T = 0 to T = +45 (45 minutes)
Secondary	Comparison of respiratory exchange ratio (RER) during high intensity interval exercise and moderate intensity continous exercise session	Ratio	T = 0 to T = +45 (45 minutes)
Secondary	Comparison of oxygen consumption (VO2) during high intensity interval exercise and moderate intensity continous exercise session	L/min	T = 0 to T = +45 (45 minutes)
Secondary	Comparison of carbon dioxide output (VCO2) during high intensity interval exercise and moderate intensity continous exercise session	L/min	T = 0 to T = +45 (45 minutes)
Secondary	Comparison of carbohydrate oxidation during high intensity interval exercise and moderate intensity continous exercise session	g/min	T = 0 to T = +45 (45 minutes)
Secondary	Comparison of lipid oxidation during high intensity interval exercise and moderate intensity continous exercise session	g/min	T = 0 to T = +45 (45 minutes)
Secondary	Comparison of resting metabolic rate after exercise session	kj/min	T =+45 to T=+120 (75 minutes)
Secondary	Plasma lactate response before, during and after cardiopulmonary exercise testing	mmol/L	30 minutes
Secondary	Plasma glucose response before, during and after cardiopulmonary exercise testing	mmol/L	30 minutes
Secondary	Respiratory exchange ratio (RER) collected continuously during cardiopulmonary exercise testing visit	L/min	30 minutes
Secondary	Oxygen consumption (VO2) collected continuously during cardiopulmonary exercise testing visit	L/min	30 minutes
Secondary	Carbon dioxide output (VCO2) collected continuously during cardiopulmonary exercise testing visit	L/min	30 minutes
Secondary	Sleep efficiency assessed by Actigraph GT3x the night before study visits compared to after study visits.	Percentage	Night 1-2
Secondary	Wake time after sleep onset assessed by Actigraph GT3x the night before study visits compared to after study visits	Mins	Night 1- 2
Secondary	Energy expenditure assessed by Actigraph GT3x.	Kcal	Day 1-3
Secondary	Physical activity level assessed by Actigraph GT3x	sedentary, light or moderate-to-vigorous	Day1-3