Diabetes type1SATURNNCT04635280
Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
A study testing any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking in people with Diabetes type1, run by Air Liquide Santé International at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes type1
- What is being tested?
- any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- 10 May 2021to 12 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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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)
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nantes - Hôpital Nord Laennec
Nantes, 44093
CHU de Toulouse - Hôpital Rangueil
Toulouse, 31059
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Diabetes type1
- Being tested
- any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking
- Keywords
- Artificial pancreas, Patient management, Technical telemonitoring, Home Healthcare Provider
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-markingDevice
A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop automatic insulin delivery system | Experimental | Adults type 1 diabetic patients equipped with a closed-loop automatic insulin delivery system (or artificial pancreas) Receives: Device: any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 30 and Day 90
Secondary outcomes (11)
Total Number of HHP Interactions
Cumulative number of HHP interactions during the study, in total and by type of contact. Unplanned additional contacts are included.
Measured: Throughout the study, up to 3 months
Cumulative Duration of HHP Interactions
Cumulative duration of HHP interactions during the study, for all contacts and by type of contact
Measured: 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.
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.
Measured: Throughout the study, up to 3 months
Quality of Life Questionnaire (EQ-5D) Summary Index 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. The summary index ranges between 0 (dead) and 1 (perfect health)
Measured: At inclusion, Day 30 and Day 90
Hypoglycaemia Fear Survey (HFS) Total Score 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.
Measured: 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
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 continuous glucose sensor - Handling all my treatment equipment (pump, glucose sensor, etc.) - Determining my insulin doses several times a day - Hearing the audible alarms of my treatment equipment (pump, glucose sensor, etc.). The number of constraints is reported.
Measured: 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
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
Measured: At inclusion and Day 90
Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90
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/concerns for treatment.
Measured: At inclusion and Day 90
HbA1c at Inclusion and Day 90
HbA1c (%) at inclusion and Day 90
Measured: Inclusion and Day 90
Glycemic Variability at Inclusion and Day 90
Glycemic variability assessed by the coefficient of variation (CV)
Measured: At inclusion and Day 90
Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90
Percentage of time spent over a 4-week period in glycemic target range, in hypoglycaemia and in hyperglycaemia. Glycemic target range: 70-180 mg/dl, hypoglycaemia: < 70 mg/dl and hyperglycaemia :> 180 mg/dl
Measured: At inclusion and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start10 May 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hélène HANAIRE, MD, PhD, Principal investigator, Hôpital de Rangueil - 31059 Toulouse - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635280
- Sponsor's protocol ID
- ALMED-19-001
- Acronym
- SATURN
- Status last verified
- Oct 2024
- First submitted
- 4 Nov 2020
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04635280
- Acronym / sponsor ID
- SATURN / ALMED-19-001
- Conditions
- Diabetes type1
- Keywords
- Artificial pancreas, Patient management, Technical telemonitoring, Home Healthcare Provider
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-loop automatic insulin delivery system | Experimental | Device: any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-markingAdults type 1 diabetic patients equipped with a closed-loop automatic insulin delivery system (or artificial pancreas) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-markingA closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm. | Device | Closed-loop automatic insulin delivery system |
Primary outcome
Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Total Number of HHP Interactions
Time frame: Throughout the study, up to 3 months
Cumulative Duration of HHP Interactions
Time frame: 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.
Time frame: Throughout the study, up to 3 months
Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90
Time frame: At inclusion, Day 30 and Day 90
Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90
Time frame: 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
Time frame: 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
Time frame: At inclusion and Day 90
Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90
Time frame: At inclusion and Day 90
HbA1c at Inclusion and Day 90
Time frame: Inclusion and Day 90
Glycemic Variability at Inclusion and Day 90
Time frame: At inclusion and Day 90
Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90
Time frame: At inclusion and Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène HANAIRE, MD, PhD principal investigator
Hôpital de Rangueil - 31059 Toulouse - France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking in people with Diabetes type1, run by Air Liquide Santé International at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire (time frame: Day 30 and Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.