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

NCT04635280 | Completed Results

• 1 other identifier: ALMED-19-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes type1

Keywords

Artificial pancreas; Patient management; Technical telemonitoring; Home Healthcare Provider

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire

  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.

  Day 30 and Day 90

• Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 Questionnaire

  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.

  Day 90

• Description of Patient Satisfaction and Experience Regarding the Management by HHP at 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.

  Day 30 and Day 90

Secondary Outcomes (11)

• 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

• Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90

  At inclusion, Day 30 and Day 90.

Study Arms (1)

Closed-loop automatic insulin delivery system

EXPERIMENTAL

Adults type 1 diabetic patients equipped with a closed-loop automatic insulin delivery system (or artificial pancreas)

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

Interventions

any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking DEVICE

A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm.

Closed-loop automatic insulin delivery system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide Santé International: lead

Study Sites (2)

CHU de Nantes - Hôpital Nord Laennec

Nantes, 44093, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Pancreas, Artificial

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Marie-Danielle MILCENT / Clinical Project Manager
• Organization: Air Liquide

fralsi-ctpublication@airliquide.com

+33 (0)1 84 76 42 39

Study Officials

• Hélène HANAIRE, MD, PhD

  Hôpital de Rangueil - 31059 Toulouse - France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 19, 2020
• Study Start: May 10, 2021
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Locations

FR (2)