N/A
N=35
Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
Diabetes type1
Bottom Line
View on ClinicalTrials.gov: NCT04635280 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire — 35; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Air Liquide Santé International
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire |
35; 35 | — |
| PRIMARY Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 Questionnaire |
33; 2 | — |
| PRIMARY Description of Patient Satisfaction and Experience Regarding the Management by HHP at Day 30 and Day 90 |
47.6; 46.8 | — |
| SECONDARY Total Number of HHP Interactions |
7.3; 2.8; 3.8 | — |
| SECONDARY Cumulative Duration of HHP Interactions |
472; 66; 329 | — |
| SECONDARY Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record. |
29; 4; 2 | — |
| SECONDARY Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90 |
0.95; 0.94; 0.94 | — |
| SECONDARY Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90 |
31.2; 25.7; 23.1 | — |
| SECONDARY Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90 |
3.4; 2.5; 2.9 | — |
| SECONDARY Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90 |
35; 31; 34; 32 | — |
| SECONDARY Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90 |
19.5; 19.1; 15.9; 15.8 | — |
| SECONDARY HbA1c at Inclusion and Day 90 |
7.35; 6.68; -0.67 | — |
| SECONDARY Glycemic Variability at Inclusion and Day 90 |
38.7; 34.1; -4.2 | — |
| SECONDARY Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 |
57.0; 71.4; 4.7; 2.1; 37.8; 26.4 | — |
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.
Eligibility Criteria
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 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.
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
Data sourced from ClinicalTrials.gov (NCT04635280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.