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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90(At inclusion, Day 30 and Day 90.)
- Total Number of HHP Interactions(Throughout the study, up to 3 months)
- Cumulative Duration of HHP Interactions(Throughout the study, up to 3 months)
- 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)
- Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90(At inclusion, Day 30 and Day 90)
- 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)
- 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)
- Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90(At inclusion and Day 90)
- HbA1c at Inclusion and Day 90(Inclusion and Day 90)
- Glycemic Variability at Inclusion and Day 90(At inclusion and Day 90)
- Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90(At inclusion and Day 90)