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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop automatic insulin delivery system | Experimental | Adults type 1 diabetic patients equipped with a closed-loop automatic insulin delivery system (or artificial pancreas) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout the study, up to 3 months |
| Cumulative Duration of HHP Interactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène HANAIRE, MD, PhD | Hôpital de Rangueil - 31059 Toulouse - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes - Hôpital Nord Laennec | Nantes | 44093 | France | |||
| CHU de Toulouse - Hôpital Rangueil |
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A total of 35 patients were enrolled from 2 french centres. First Patient Enrolled: 10 May 2021 Last patient Enrolled: 22 September 2021 Last Patient Completed: 12 January 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid Closed-loop Automatic Insulin Delivery System | A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2024 |
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Cumulative duration of HHP interactions during the study, for all contacts and by type of contact
| 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. | 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) | 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. | 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. | 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 | 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. | At inclusion and Day 90 |
| HbA1c at Inclusion and Day 90 | HbA1c (%) at inclusion and Day 90 | Inclusion and Day 90 |
| Glycemic Variability at Inclusion and Day 90 | Glycemic variability assessed by the coefficient of variation (CV) | 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 | At inclusion and Day 90 |
| Toulouse |
| 31059 |
| France |
| COMPLETED |
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| NOT COMPLETED |
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ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid Closed-loop Automatic Insulin Delivery System | A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HbA1c in category | Count of Participants | Participants |
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| HbA1c | Mean | Standard Deviation | percentage of glycated hemoglobin |
| |||||||||||||||||
| Time since type 1 diabetes diagnosis | Time between the date of type 1 diabetes diagnosis and the date of inclusion visit, converted in years | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-To-Treat (ITT) population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Count of Participants | Participants | Day 30 and Day 90 |
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| Primary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Count of Participants | Participants | Day 90 |
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| Primary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria All participants completed at least partially the questionnaire; 27 participants completed entirely the questionnaire at D30 and 30 participants completed entirely the questionnaire at D90; 31 participants completed entirely the questionnaire at either D30 or D90. | Posted | Mean | Standard Deviation | units on a scale | Day 30 and Day 90 |
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| Secondary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | number of contacts | Throughout the study, up to 3 months |
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| Secondary | Cumulative Duration of HHP Interactions | Cumulative duration of HHP interactions during the study, for all contacts and by type of contact | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | minutes | Throughout the study, up to 3 months |
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| Secondary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Count of Participants | Participants | Throughout the study, up to 3 months |
|
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| Secondary | 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) | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | units on a scale | At inclusion, Day 30 and Day 90 |
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| Secondary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | score on a scale | At inclusion, Day 30 and Day 90. |
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| Secondary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | number of constraints ticked | At inclusion, Day 30 and Day 90 |
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| Secondary | 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 | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Count of Participants | Participants | At inclusion and Day 90 |
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| Secondary | 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. | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | units on a scale | At inclusion and Day 90 |
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| Secondary | HbA1c at Inclusion and Day 90 | HbA1c (%) at inclusion and Day 90 | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Inclusion and Day 90 |
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| Secondary | Glycemic Variability at Inclusion and Day 90 | Glycemic variability assessed by the coefficient of variation (CV) | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | percentage of coefficient of variation | At inclusion and Day 90 |
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| Secondary | 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 | ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria | Posted | Mean | Standard Deviation | percentage of time | At inclusion and Day 90 |
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From the time signed informed consent is obtained until the end of the study for the patient, up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hybrid Closed-loop Automatic Insulin Delivery System | A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm. | 0 | 35 | 0 | 35 | 12 | 35 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site inflammation | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Diabetic ketosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Ketosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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The only disclosure restriction on the PI is that the Sponsor can review results communications prior to public release. According to Article R. 5121-13 of the French Public Health Code, the results of the Research may not be published or the subject of written or oral communications by the PI without prior written consent of the Sponsor.The disclosure restriction applies to the Parties during the entire duration of the agreement and as long as the confidential data are not in the public domain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie-Danielle MILCENT / Clinical Project Manager | Air Liquide | +33 (0)1 84 76 42 39 | fralsi-ctpublication@airliquide.com |
| Oct 7, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| 8%-10% |
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| Title | Denominators | Categories | ||||
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| Hba1c at Inclusion |
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| Hba1c at Day 90 |
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| Absolute change of HbA1c at D90 from inclusion |
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