SATURN: Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Closed-loop automatic insulin delivery system 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
A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and a dedicated terminal.
|
Outcome Measures
Primary Outcome Measures
- Description of Patient satisfaction at Day 30, by the CSQ-8 questionnaire [Day 30]
CSQ-8 is a validated questionnaire that measures patients' overall satisfaction with their management in general.
- Maintenance of Patient satisfaction at Day 90, by the CSQ-8 questionnaire [Day 90]
CSQ-8 is a validated questionnaire that measures patients' overall satisfaction with their management in general.
- Description of Patient satisfaction and experience at Day 30 by the "You and your management by your home healthcare provider" questionnaire [Day 30]
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
- Description of Patient satisfaction and experience at Day 90 by the "You and your management by your home healthcare provider" questionnaire [Day 90]
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
Secondary Outcome Measures
- Description of HHP management: number of HHP interactions [Throughout the study, up to an average of 4 months]
Number of HHP interactions with the patient by phase (pre-installation, installation, and follow-up)
- Description of HHP management: characterization of the HHP interactions [Throughout the study, up to an average of 4 months]
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).
- Comparison of the HHP observed management with the theoretical management described in the medical device's information record. [Throughout the study, up to an average of 4 months]
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
- Assessment of HHP satisfaction [through study completion, an average of 10 months]
The satisfaction of HHP nurses is assessed using a questionnaire internally developed by the sponsor
- Assessment of patients' experience with medical devices by the "You and medical devices" questionnaire [At inclusion]
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.
- Assessment of patients' feelings about their current and future state of health by the "You and your health" questionnaire [At inclusion and Day 90]
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.
- Assessment of patients' quality of life by the EQ 5D-5L questionnaire [At inclusion, Day 30 and Day 90]
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")
- Assessment of patients' quality of life and daily constraints by the HFS-II questionnaire [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
- Assessment of daily constraints encountered by patients based on the past month, with the question "You and your daily constraints" [At inclusion, Day 30 and Day 90]
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.
- 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") [At inclusion, Day 30 and Day 90]
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").
- Assessment of patients' beliefs related to medical treatment by the specific section of the BMQ (Beliefs about Medicines Questionnaire) questionnaire [At inclusion, Day 30 and Day 90]
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.
- Assessment of investigator satisfaction [through study completion, an average of 10 months]
The satisfaction of investigator regarding HHP management is assessed using a questionnaire internally developed.
- Evolution of patients' clinical profile [Day 0 and Day 90]
HbA1c (%)
- Evolution of patients' clinical profile : Glycemic variability [At inclusion and Day 90]
Variability assessed by the coefficient of variation
- Evolution of patients' clinical profile : Percentage of time spent over a 4-week period in glycemic target range, in hypoglycaemia and in hyperglycaemia [At inclusion, Day 30 and Day 90]
Glycemic target range: 70-180 mg/dl, hypoglycaemia: < 70 mg/dl and hyperglycaemia :> 180 mg/dl
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 1 diabetic patient diagnosed for at least 2 years
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Patient treated with an external insulin pump for at least 6 months
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Patient with an HbA1c level less than or equal to 10% in the past 4 months
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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)
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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
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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
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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)
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Patient registered with a Social Security scheme
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Patient who has agreed to comply with the requirements of the study and has signed the free and informed consent form
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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:
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Patient with any serious pathology that could affect his/her participation in the study
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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
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Patient benefiting from a legal protection measure
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Pregnant or breastfeeding woman
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Absence of contraception deemed effective by the investigator for a woman of child-bearing age
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Psychological and/or physical state which could affect the proper follow-up of the study procedures
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Severe hypoglycaemia which has led to convulsions or a loss of consciousness in the last 12 months
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Decrease in the perceived sensation of hypoglycaemia, in the investigator's judgement
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Altered renal function (creatinine clearance < 30 ml/min measured in the last 6 months)
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Patient who has had a pancreas or pancreatic islet transplant
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Patient with serious uncorrected hearing and/or visual problems
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Patient included in another clinical study or who has taken part in another clinical study in the last 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nantes - Hôpital Nord Laennec | Nantes | France | 44093 | |
| 2 | CHU de Toulouse - Hôpital Rangueil | Toulouse | France | 31059 |
Sponsors and Collaborators
- Air Liquide Santé International
Investigators
- Principal Investigator: Hélène HANAIRE, MD, PhD, Hôpital de Rangueil - 31059 Toulouse - France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALMED-19-001