Trial Outcomes & Findings for Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System (NCT NCT04635280)

A total of 35 patients were enrolled from 2 french centres. First Patient Enrolled: 10 May 2021 Last patient Enrolled: 22 September 2021 Last Patient Completed: 12 January 2022

Race and Ethnicity were not collected from any participant.

Satisfaction regarding the management in general was assessed using the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 is a validated questionnaire that measures patients' overall satisfaction with their management in general. It contains 8 questions and each question is answered using a 4-point scale. The score ranges from 8 to 32, with higher values indicating higher satisfaction. Patients were considered as satisfied if they reached a score above 20 points.

Satisfaction regarding the management in general was assessed using the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 is a validated questionnaire that measures patients' overall satisfaction with their management in general. It contains 8 questions and each question is answered using a 4-point scale. The score ranges from 8 to 32, with higher values indicating higher satisfaction. Satisfaction was defined by a score above 20 points. Maintenance of satisfaction is measured on D90 by a score above 20 points which has not decreased by more than 4 points compared with D30.

The questionnaire was developed for the study by the French Diabetes Federation, aiming at evaluating patient satisfaction and experience with their management by the HHP. 16 questions assessed the proactiveness, availability and HHP nurse advice. A global score ranging from 13 to 57 was calculated, with higher values indicating higher satisfaction. The global score was only calculated when all questions were answered.

Cumulative number of HHP interactions during the study, in total and by type of contact. Unplanned additional contacts are included.

Cumulative duration of HHP interactions during the study, for all contacts and by type of contact

Number and percentage of patients who required increased follow-up/support, identical follow-up/support and reduced follow-up/ support in relation to what was recommended in the supplier's information record. The maximal number of contacts expected in the supplier's information record was 9 contacts.

The patient's quality of life was assessed by the quality of life questionnaire (EQ-5D-5L), validated in French Language. It is composed of 5 items each corresponding to a specific dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and divided into 5 levels of perception (1. no problem, 2. slight problems, 3. moderate problems, 4. severe problems, 5. extreme problems/incapacity). The digits for the 5 dimensions were combined in a 5-digit code describing the patient's health state and were converted into a summary index value using the french value sets. The summary index ranges between 0 (dead) and 1 (perfect health)

The HFS-II is a validated questionnaire that will be used to measure quality of life and daily constraints with respect to hypoglycaemia-related behaviours and concerns in adults with type 1 diabetes. The HFS total score ranges from 0 to 132, with higher values indicating a higher fear of hypoglycemia.

The patient's everyday constraints were assessed based on the past month, with a questionnaire in the form of a pre-established multiple-choice list. The questionnaire was developed by the French Diabetes Federation and includes 12 items: - Managing other people's perceptions of my diabetes - Anticipating my activities - Thinking about my diabetes all the time - Dealing with my diabetes all the time - Fear of experiencing hypoglycaemia - Fear of experiencing hyperglycaemia - Uncertainties about my future health - Carrying one or more treatment devices on me at all times - Handling my continuous glucose sensor - Handling all my treatment equipment (pump, glucose sensor, etc.) - Determining my insulin doses several times a day - Hearing the audible alarms of my treatment equipment (pump, glucose sensor, etc.). The number of constraints is reported.

The expected and perceived benefits with respect to the closed-loop automated insulin delivery system was assessed by the questionnaire "You and the Hybrid Closed-Loop (HCL) automated insulin delivery system" developed by the French Diabetes Federation for the study. Only 2 benefits are presented

The patient's beliefs about the medical treatment were assessed by the specific section of the BMQ (Beliefs about Medicines Questionnaire), validated in French for diabetes. The specific BMQ consists of two parts: Part one contains five questions related to the need for the treatment and part two contains five questions on concerns about the prescription. The 10 questions are answered using a 5-point scale (1. strongly disagree, 2. disagree, 3. uncertain, 4. agree and 5. strongly agree). The results take the form of two scores ranging from 5 to 25, with higher value indicating higher need/concerns for treatment.

HbA1c (%) at inclusion and Day 90

Glycemic variability assessed by the coefficient of variation (CV)

Percentage of time spent over a 4-week period in glycemic target range, in hypoglycaemia and in hyperglycaemia. Glycemic target range: 70-180 mg/dl, hypoglycaemia: \< 70 mg/dl and hyperglycaemia :\> 180 mg/dl