Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France

Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)

Change in Time In Tight Range (TITR, 70 - 140 mg/dL) (%)

Change in Time Above Range (TAR, > 250 mg/dL and > 180 mg/dL; for pregnant women: TAR, > 140 mg/dL) (%)

Change in Time Below Range (TBR, < 70 mg/dL and < 54 mg/dL; for pregnant women: TBR, < 63 mg/dL and < 54 mg/dL) (%)

Change in average glucose levels from CGM sensor data (mg/dL)

Change in Standard Deviation (SD) of glucose

Change in Coefficient of Variation (CV) of glucose derived from CGM sensor data (%)

Change in Glucose Management Indicator (GMI) (%) derived from CGM sensor data

Change in HbA1c (%)

Time spent in hybrid closed-loop (%)

Description of evolution rate of advanced features

Self-administered questionnaire: Problem Areas In Diabetes (PAID)

Following versions will be used: Adult version (18 and above), Teen version (PAID-T) in adolescents aged 12-18 years, and for their parents (P-PAID-T), Children version (PAID-C) in children aged 8-11 years and their parents (P-PAID-C). P-PAID-C will be also used in parents of children aged <8 years.

The Problem Areas in Diabetes (PAID) questionnaire assesses diabetes-related emotional distress across patients and caregivers using age- and role-specific versions. The PAID (adults), PAID-T (teens), and PAID-C (children) are self-reported, while P-PAID-T and P-PAID-C are completed by parents of teens and children, respectively. All versions use Likert scales and are typically transformed to a 0-100 score, with higher values indicating greater distress.

Self-administered questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQs)

Following versions will be used: Adult version (18 and above), Teen version (DTSQs-Teen) in adolescents aged 13-18 years. For their parents and parents of children aged <13 years, Parent version (DTSQs-Parent) will be used.

DTSQQs for adults contains 8 items, DTSQs-Teen has 12 items and DTSQs-Parent has 14 items. The total score of the DTSQs is calculated by summing six items (excluding perceived hypo/hyperglycaemia), each rated 0 to 6, resulting in a total score from 0 to 36, with higher scores indicating better treatment satisfaction.

Self-administered questionnaire Hypoglycemia Fear Survey II (HFS-II).

The following versions will be used: Adult version, Children version (HFS-II children) for children aged 6 years and above, Parent version (HFS-II parent) for children aged 8 years and above, and Parent version for children aged <8 years (HFS-II parent of young children).

HFS-II consists of items ranging from 0 (never) to 4 (almost always) (9 items in the Adult version, 25 in the Teen version and 26 in the Parent versions). It is composed of two subscales: a Behavior score and a Worry score, with higher scores reflecting greater behavioral or emotional impact.

Self-administered questionnaire: Pittsburgh Sleep Quality Index (PSQI).

The questionnaire will be used in adults and parents. It contains 19 items which are grouped into 7 components that contribute to the overall score. Each component is scored from 0 to 3, where 0 indicates no difficulty and 3 indicates severe difficulty. The 7 component scores are summed to produce a total score ranging from 0 to 21.

Participant reported perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia and sleep quality measured with a question " Patient Global Impression of Change " (PGIC) (one for each dimension).

Each PGIC will be used in adults, parents and children aged 11 years and above and consisting of one question with 7 modalities from 'Much worse" to "Much better".

Number of diabetic ketoacidosis events, severe hypoglycemia requiring assistance (medical and non-medical), unplanned hospitalizations related to diabetes and other complications related to the use of the system that meet the predefined acceptance criteria based on safety parameters for the target devices.