Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System

Not Applicable

Completed

Conditions: Diabetes type1

Interventions: Device: any closed-loop automatic insulin delivery system (or artificial pancreas) CE-marking

Registration Number: NCT04635280

Lead Sponsor: Air Liquide Santé International

Brief Summary: SATURN study aims at evaluating Home Healthcare Provider (HHP) Management of type 1 diabetic patients using a closed-loop automatic insulin delivery system (or artificial pancreas), and specifically satisfaction and interactions of all people involved (patients, HHPs, hospital healthcare teams) after 1 and 3 months of follow-up, under normal conditions of use.

Detailed Description: National, multi-centre, longitudinal, non-comparative interventional study with minimal risks and constraints.

Two French hospitals and their HHP representatives will participate in the study. A recruitment of a total of 35 patients is expected.

Adult type 1 diabetic patients for whom the investigator prescribes the use of a closed-loop automatic insulin delivery system (or artificial pancreas) consisting in an insulin pump with a continuous glucose monitoring system combined with a dedicated terminal.

Patients will be monitored for a period of 3 months, starting from the end of the device installation procedure.

HHP Management comprises three distinct phases: pre-installation, installation and follow-up during which number, nature and duration of contacts (visits/telephone calls) may vary according to patient's needs, investigator's judgement and practice, and judgement of HHP staff.

Pre-installation and installation phases consist of two patients' visits at hospital, and of two to five visits from HHP staff to patients' home (only one visit at hospital). Follow-up phase held after installation consists of four patients' contacts (phone contact and/or home visit) performed by HHP staff.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

Type 1 diabetic patient diagnosed for at least 2 years
Patient treated with an external insulin pump for at least 6 months
Patient with an HbA1c level less than or equal to 10% in the past 4 months
Patient with U100 short-acting insulin (Novorapid or Humalog) requirements between the lower and upper bounds set by the pump of the closed-loop automatic insulin delivery system (or artificial pancreas)
Patient who is not isolated, who does not live alone or who has a "resource" person living nearby with her/his own telephone and a key to the patient's home
Patient living in an area covered by a Global System for Mobile Communications (GSM) network and not planning to travel outside France or outside an area covered by a GSM network within 30 days of the closed-loop automatic insulin delivery system (or artificial pancreas) being installed
Patient at least 18 years old and whose age complies with the eligibility criteria for each medical device of the closed-loop automatic insulin delivery system (or artificial pancreas)
Patient registered with a Social Security scheme
Patient who has agreed to comply with the requirements of the study and has signed the free and informed consent form
Patient who the investigator deems capable of using a closed-loop automatic insulin delivery system (or artificial pancreas) under normal conditions of use.

Exclusion Criteria

Patient with any serious pathology that could affect his/her participation in the study
Patient undergoing treatment that could affect the physiology of diabetes, i.e., that leads to interactions with glucose and/or insulin, in the investigator's judgement
Patient benefiting from a legal protection measure
Pregnant or breastfeeding woman
Absence of contraception deemed effective by the investigator for a woman of child-bearing age
Psychological and/or physical state which could affect the proper follow-up of the study procedures
Severe hypoglycaemia which has led to convulsions or a loss of consciousness in the last 12 months
Decrease in the perceived sensation of hypoglycaemia, in the investigator's judgement
Altered renal function (creatinine clearance < 30 ml/min measured in the last 6 months)
Patient who has had a pancreas or pancreatic islet transplant
Patient with serious uncorrected hearing and/or visual problems
Patient included in another clinical study or who has taken part in another clinical study in the last 30 days

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed-loop automatic insulin delivery system	any closed-loop automatic insulin delivery system (or artificial pancreas) CE-marking	Adults type 1 diabetic patients equiped with a closed-loop automatic insulin delivery system (or artificial pancreas)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire	Day 30 and Day 90	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.
Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 Questionnaire	Day 90	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.
Description of Patient Satisfaction and Experience Regarding the Management by HHP at Day 30 and Day 90	Day 30 and Day 90	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.

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90	At inclusion, Day 30 and Day 90.	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.
Total Number of HHP Interactions	Throughout the study, up to 3 months	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	Throughout the study, up to 3 months	Cumulative duration of HHP interactions during the study, for all contacts and by type of contact
Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record.	Throughout the study, up to 3 months	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.
Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90	At inclusion, Day 30 and Day 90	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)
Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90	At inclusion, Day 30 and Day 90	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.
Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90	At inclusion and Day 90	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
Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90	At inclusion and Day 90	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	Inclusion and Day 90	HbA1c (%) at inclusion and Day 90
Glycemic Variability at Inclusion and Day 90	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 at Inclusion and Day 90	At inclusion and Day 90	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