Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
CompletedNAResults postedLast updated 15 October 2024
What this trial tests
NA trial testing any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking in Diabetes type1 in 35 participants. Completed in 12 January 2022.
18 and older, any sex, with Diabetes type1. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 QuestionnairePrimary· 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.
Patients satisfied - Day 30
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
35
Patients satisfied - Day 90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
35
Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 QuestionnairePrimary· 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.
Satisfaction maintained
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
33
Satisfaction not maintained
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
2
Description of Patient Satisfaction and Experience Regarding the Management by HHP at Day 30 and Day 90Primary· 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
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
47.6
± 5.2
Day 90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
46.8
± 5.3
Total Number of HHP InteractionsSecondary· 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.
Total number of contacts
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
7.3
± 1.5
Phone contacts
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
2.8
± 1.5
Physical visits contacts
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
3.8
± 1.1
Cumulative Duration of HHP InteractionsSecondary· Throughout the study, up to 3 months
Cumulative duration of HHP interactions during the study, for all contacts and by type of contact
All contacts
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
472
± 123
Phone contacts
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
66
± 47
Physical visits contacts
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
329
± 97
Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record.Secondary· 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.
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
29
Hybrid Closed-loop Automatic Insulin Delivery System
4
Hybrid Closed-loop Automatic Insulin Delivery System
2
Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90Secondary· 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. T
Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
0.95
± 0.10
Day 30
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
0.94
± 0.09
Day 90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
0.94
± 0.10
Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90Secondary· 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.
Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
31.2
± 15.7
Day 30
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
25.7
± 20.1
Day 90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
23.1
± 16.8
Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90Secondary· 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 continuou
Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
3.4
± 1.8
Day 30
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
2.5
± 1.2
Day 90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
2.9
± 1.8
Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90Secondary· 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
Expected experiencing less hypo/ hyperglycemia at Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
35
Noticed less hypo/ hyperglycemia at D90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
31
Expected spending more time in glycemic target at inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
34
Noticed spending more time in glycemic target at D90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
32
Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90Secondary· 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/conc
BMQ - higher need score at Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
19.5
± 2.3
BMQ - higher need score at D90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
19.1
± 2.1
BMQ - concerns score at Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
15.9
± 2.3
BMQ - concerns score at D90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
15.8
± 2.3
HbA1c at Inclusion and Day 90Secondary· Inclusion and Day 90
HbA1c (%) at inclusion and Day 90
Hba1c at Inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
7.35
± 0.77
Hba1c at Day 90
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
6.68
± 0.63
Absolute change of HbA1c at D90 from inclusion
Group
Value
95% CI
Hybrid Closed-loop Automatic Insulin Delivery System
-0.67
± 0.42
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time signed informed consent is obtained until the end of the study for the patient, up to 3 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Hybrid Closed-loop Automatic Insulin Delivery System
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Air Liquide Santé International
Last refreshed: 15 October 2024
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