Diabetes type1
Conditions
Keywords
Artificial pancreas, Patient management, Technical telemonitoring, Home Healthcare Provider
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.
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.
Interventions
DEVICEany closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking
A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and an algorithm.
Sponsors
Air Liquide Santé International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90 | 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) |
| Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90 | 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. |
| Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90 | 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. |
| Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90 | 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 |
| Total Number of HHP Interactions | 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. |
| HbA1c at Inclusion and Day 90 | Inclusion and Day 90 | HbA1c (%) at inclusion and Day 90 |
| Glycemic Variability at Inclusion and Day 90 | At inclusion and Day 90 | Glycemic variability assessed by the coefficient of variation (CV) |
| Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | 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 |
| Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90 | 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/concerns for treatment. |
| Cumulative Duration of HHP Interactions | Throughout the study, up to 3 months | Cumulative duration of HHP interactions during the study, for all contacts and by type of contact |
| 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 | 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. |
Countries
France
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Hybrid Closed-loop Automatic Insulin Delivery System | — |
|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 11.5 | — |
| HbA1c | 7.35 percentage of glycated hemoglobin STANDARD_DEVIATION 0.77 | — |
| HbA1c in category <7% | 10 Participants | — |
| HbA1c in category 7%-<8% | 18 Participants | — |
| HbA1c in category 8%-10% | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 35 participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
| Time since type 1 diabetes diagnosis | 23.3 years STANDARD_DEVIATION 12.4 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 12 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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.
Time frame: Day 30 and Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Description of Patient Satisfaction and Experience Regarding the Management by HHP at Day 30 and Day 90 | Day 30 | 47.6 units on a scale | Standard Deviation 5.2 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Description of Patient Satisfaction and Experience Regarding the Management by HHP at Day 30 and Day 90 | Day 90 | 46.8 units on a scale | Standard Deviation 5.3 |
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.
Time frame: Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 Questionnaire | Satisfaction maintained | 33 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 Questionnaire | Satisfaction not maintained | 2 Participants |
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.
Time frame: Day 30 and Day 90
Population: Intention-To-Treat (ITT) population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire | Patients satisfied - Day 30 | 35 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire | Patients satisfied - Day 90 | 35 Participants |
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.
Time frame: At inclusion and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90 | BMQ - higher need score at Inclusion | 19.5 units on a scale | Standard Deviation 2.3 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90 | BMQ - higher need score at D90 | 19.1 units on a scale | Standard Deviation 2.1 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90 | BMQ - concerns score at Inclusion | 15.9 units on a scale | Standard Deviation 2.3 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90 | BMQ - concerns score at D90 | 15.8 units on a scale | Standard Deviation 2.3 |
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.
Time frame: Throughout the study, up to 3 months
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record. | Reduced (< 9 contacts) | 29 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record. | Identical (=9 contacts) | 4 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record. | Increased (>9 contacts) | 2 Participants |
Secondary
Cumulative Duration of HHP Interactions
Cumulative duration of HHP interactions during the study, for all contacts and by type of contact
Time frame: Throughout the study, up to 3 months
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Cumulative Duration of HHP Interactions | All contacts | 472 minutes | Standard Deviation 123 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Cumulative Duration of HHP Interactions | Phone contacts | 66 minutes | Standard Deviation 47 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Cumulative Duration of HHP Interactions | Physical visits contacts | 329 minutes | Standard Deviation 97 |
Secondary
Glycemic Variability at Inclusion and Day 90
Glycemic variability assessed by the coefficient of variation (CV)
Time frame: At inclusion and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Glycemic Variability at Inclusion and Day 90 | Glycemic CV at Inclusion | 38.7 percentage of coefficient of variation | Standard Deviation 5.8 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Glycemic Variability at Inclusion and Day 90 | Glycemic CV at Day D90 | 34.1 percentage of coefficient of variation | Standard Deviation 5 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Glycemic Variability at Inclusion and Day 90 | Absolute change of Glycemic CV at D90 from installation | -4.2 percentage of coefficient of variation | Standard Deviation 4.5 |
Secondary
HbA1c at Inclusion and Day 90
HbA1c (%) at inclusion and Day 90
Time frame: Inclusion and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | HbA1c at Inclusion and Day 90 | Hba1c at Inclusion | 7.35 percentage of glycated hemoglobin | Standard Deviation 0.77 |
| Hybrid Closed-loop Automatic Insulin Delivery System | HbA1c at Inclusion and Day 90 | Hba1c at Day 90 | 6.68 percentage of glycated hemoglobin | Standard Deviation 0.63 |
| Hybrid Closed-loop Automatic Insulin Delivery System | HbA1c at Inclusion and Day 90 | Absolute change of HbA1c at D90 from inclusion | -0.67 percentage of glycated hemoglobin | Standard Deviation 0.42 |
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.
Time frame: At inclusion, Day 30 and Day 90.
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90 | Inclusion | 31.2 score on a scale | Standard Deviation 15.7 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90 | Day 30 | 25.7 score on a scale | Standard Deviation 20.1 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90 | Day 90 | 23.1 score on a scale | Standard Deviation 16.8 |
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.
Time frame: At inclusion, Day 30 and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90 | Inclusion | 3.4 number of constraints ticked | Standard Deviation 1.8 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90 | Day 30 | 2.5 number of constraints ticked | Standard Deviation 1.2 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90 | Day 90 | 2.9 number of constraints ticked | Standard Deviation 1.8 |
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
Time frame: At inclusion and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90 | Expected experiencing less hypo/ hyperglycemia at Inclusion | 35 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90 | Noticed less hypo/ hyperglycemia at D90 | 31 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90 | Expected spending more time in glycemic target at inclusion | 34 Participants |
| Hybrid Closed-loop Automatic Insulin Delivery System | Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90 | Noticed spending more time in glycemic target at D90 | 32 Participants |
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
Time frame: At inclusion and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | Time in range 70-180 mg/dl at inclusion | 57.0 percentage of time | Standard Deviation 13.3 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | Time in range 70-180 mg/dl at D90 | 71.4 percentage of time | Standard Deviation 9.4 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | Time in hypoglycaemia < 70 mg/dl at inclusion | 4.7 percentage of time | Standard Deviation 4.6 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | Time in hypoglycaemia < 70 mg/dl at D90 | 2.1 percentage of time | Standard Deviation 1.7 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | Time in hyperglycaemia > 180 mg/dl at inclusion | 37.8 percentage of time | Standard Deviation 14.9 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90 | Time in hyperglycaemia > 180 mg/dl at D90 | 26.4 percentage of time | Standard Deviation 9.5 |
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)
Time frame: At inclusion, Day 30 and Day 90
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90 | Inclusion | 0.95 units on a scale | Standard Deviation 0.1 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90 | Day 30 | 0.94 units on a scale | Standard Deviation 0.09 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90 | Day 90 | 0.94 units on a scale | Standard Deviation 0.1 |
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.
Time frame: Throughout the study, up to 3 months
Population: ITT population: all included patients fitted with the device who met all of the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop Automatic Insulin Delivery System | Total Number of HHP Interactions | Total number of contacts | 7.3 number of contacts | Standard Deviation 1.5 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Total Number of HHP Interactions | Phone contacts | 2.8 number of contacts | Standard Deviation 1.5 |
| Hybrid Closed-loop Automatic Insulin Delivery System | Total Number of HHP Interactions | Physical visits contacts | 3.8 number of contacts | Standard Deviation 1.1 |