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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Equipped With the Closed-loop Automated Insulin Delivery System (or Artificial Pancreas), Under Normal Conditions of Use

Conditions
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Diabetes type1

Intervention / Treatment
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* Device: any closed-loop automatic insulin delivery system (or artificial pancreas) CE-marking


Participation Criteria
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Eligibility Criteria
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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 GSM (Global System for Mobile Communications) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed-loop automatic insulin delivery system<br>Adults type 1 diabetic patients equiped with a closed-loop automatic insulin delivery system (or artificial pancreas) | Device: any closed-loop automatic insulin delivery system (or artificial pancreas) CE-marking<br>* A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and a dedicated terminal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of Patient satisfaction at Day 30, by the CSQ-8 questionnaire | CSQ-8 is a validated questionnaire that measures patients' overall satisfaction with their management in general. | Day 30 | 
| Maintenance of Patient satisfaction at Day 90, by the CSQ-8 questionnaire | CSQ-8 is a validated questionnaire that measures patients' overall satisfaction with their management in general. | Day 90 | 
| Description of Patient satisfaction and experience at Day 30 by the You and your management by your home healthcare provider questionnaire | The questionnaire You and your management by your home healthcare provider is a questionnaire internally developed for the study aiming at evaluating patient satisfaction and experience with their management by the HHP | Day 30 | 
| Description of Patient satisfaction and experience at Day 90 by the You and your management by your home healthcare provider questionnaire | The questionnaire You and your management by your home healthcare provider is a questionnaire internally developed for the study aiming at evaluating patient satisfaction and experience with their management by the HHP | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of HHP management: number of HHP interactions | Number of HHP interactions with the patient by phase (pre-installation, installation, and follow-up) | Throughout the study, up to an average of 4 months | 
| Description of HHP management: characterization of the HHP interactions | Characterization of the HHP interactions by the type (visits / phone calls), the time spent in categories, the reason for these interactions and the location of visits (home / hospital). | Throughout the study, up to an average of 4 months | 
| Comparison of the HHP observed management with the theoretical management described in the medical device's information record. | 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 | Throughout the study, up to an average of 4 months | 
| Assessment of HHP satisfaction | The satisfaction of HHP nurses is assessed using a questionnaire internally developed by the sponsor | through study completion, an average of 10 months | 
| Assessment of patients' experience with medical devices by the You and medical devices questionnaire | The questionnaire You and medical devices is a questionnaire internally developed for the study and is used to determine the patient's profile with regard to their experience with medical devices. | At inclusion | 
| Assessment of patients' feelings about their current and future state of health by the You and your health questionnaire | The questionnaire  You and your health  is a questionnaire internally developed for the study and is used to assess the patient's feelings about their current and future state of health. | At inclusion and Day 90 | 
| Assessment of patients' quality of life by the EQ 5D-5L questionnaire | The EQ-5D-5L is a validated questionnaire that will be used to measure the patient's quality of life in the context of using a closed-loop automated insulin delivery system (or artificial pancreas) | At inclusion, Day 30 and Day 90 | 
| Assessment of patients' quality of life and daily constraints by the HFS-II questionnaire | 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 | At inclusion, Day 30 and Day 90. | 
| Assessment of daily constraints encountered by patients based on the past month, with the question You and your daily constraints | The questionnaire  You and your daily constraints  is a questionnaire internally developed for the study and is used to assess the daily constraints encountered by the patient in the past month based on a pre-established multiple-choice list. | At inclusion, Day 30 and Day 90 | 
| Assessment of expected and perceived benefits with respect to the closed-loop automated insulin delivery system (or artificial pancreas) by the questionnaire You and the closed-loop automated insulin delivery system (or artificial pancreas) | The questionnaire You and the closed-loop automated insulin delivery system (or artificial pancreas) is a questionnaire internally developed for the study and is used to assess the expected and perceived benefits of the closed-loop automated insulin delivery system (or artificial pancreas). | At inclusion, Day 30 and Day 90 | 
| Assessment of patients' beliefs related to medical treatment by the specific section of the BMQ (Beliefs about Medicines Questionnaire) questionnaire | The BMQ is a validated questionnaire. The specific section of this questionnaire will be used. It describes the patient's perception of the Medical Device in a wider sense. | At inclusion, Day 30 and Day 90 | 
| Assessment of investigator satisfaction | The satisfaction of investigator regarding HHP management is assessed using a questionnaire internally developed. | through study completion, an average of 10 months | 
| Evolution of patients' clinical profile | HbA1c (%) | Day 0 and Day 90 | 
| Evolution of patients' clinical profile : Glycemic variability | Variability assessed by the coefficient of variation | At inclusion and Day 90 | 
| Evolution of patients' clinical profile : 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 | At inclusion, Day 30 and Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial pancreas, Patient management, Technical telemonitoring, Home Healthcare Provider