Effects of Long Duration Cycling in People With Type 1 Diabetes

Percentage of enrolled participants for whom all planned study data are successfully collected and available in the study database at the final follow-up visit. A complete multimodal dataset is defined as: 1) continuous monitoring data for the full wear period used in the study, 2) saliva and urine samples obtained immediately before and immediately after the cycling event (visit 3), and 3) cycling performance and physiological data (heart rate, power, GPS) recorded during the gravel cycling event (visit 3).

Number of events where CGM glucose values remain below 70 mg/dl for ≥ 15 minutes. Two events are considered distinct when glucose values rise above 70 mg/dl for at least 15 minutes between them.

Daily glucose variability assessed as the percent coefficient of variation (CV) of CGM sensor glucose values over the CGM monitoring period.

Daily glucose variability assessed as the interquartile range (IQR) of CGM sensor glucsoe values over the CGM monitoring period.

Average HbA1c estimated using the Glucose Management Indicator derived from CGM data.

Instantaneous heart rate, in beats per minute, recorded continuously (1-second intervals or device default sampling rate) using a chest strap heart-rate monitor (Garmin HRM-Pro or Garmin HRM 200) from the start to the end of the gravel cycling event. The resulting hear-rate time series will be stored for later exploratory analyses.

Instantaneous cycling power, in watts, recorded continuously using pedal-based power meters (Favero Assioma) throughout the gravel cycling event. The resulting power time series will be stored for later exploratory analyses, including calculation of average and maximal power, normalized power, power-zone distribution, lef/right power balance, cadence, and other derived performance metrics.

LBGI calculated from CGM sensor glucose values over the CGM monitoring period.

HBGI calculated from CGM sensor glucose values over the CGM monitoring period.

Number of exercise sessions recorded manually by participants during CGM monitoring using the study application or diary. Exercise events are defined as the reported period plus 2 hours after exercise. For each exercise event, CGM-based glucose metrics (e.g., median glucose, interquartile range, percentage of time in predefined glucose ranges, glucose rate of change, glucose area under the curve) and associated treatment actions (correction bolus, rescue carbohydrates intake, hypoglycemic events) will be derived for exploratory analyses. The predefined gravel cycling event is characterized in separate outcomes.

Number of meal events recorded by participants during CGM monitoring using the study application or diary. Meal events are defined as the reported meal time plus 4 hours. For each meal event, CGM-based glucose metrics (e.g., median glucose, interquartile range, percentage of time in predefined glucose ranges, glucose rate of change, glcuose area under the curve, hypoglycemic events) will be derived for exploratory analyses.

Total insulin dose per day (U/day) during CGM monitoring, calculated as the sum of basal insulin, meal boluses, and correction boluses recorded from insulin devices and/or the study application. Summary measures (e.g., mean and variability of the total daily insulin dose and basal/bolus ratio) will be derived for exploratory analyses

Total carbohydrate intake, in grams, per day during CGM monitoring, including meal and rescue carbohydrates, recorded using the study application or diary. Summary measures (e.g., mean daily carbohydrate intake and frequency of rescue carbohydrate use) will be derived for exploratory analyses.