Diabetes Type 2
Conditions
Brief summary
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients. A wide acceptance of the Artificial Pancreas (AP) usage in T2D care will strongly depend on the identification of subpopulations and care settings where the AP could significantly improve the risk- and cost-benefit balances of T2D management as compared to established practice. The aim of this interventional study, therefore, is to investigate whether a therapeutic solution combining an automated insulin delivery AP system with a tailored Home Healthcare Provider (HHP) service can improve blood glucose control, reduce the rate of acute metabolic complications (hypoglycaemia and hyperglycaemia), improve both the patients quality of life and experience, and reduce the healthcare related costs in patients with uncontrolled T2D needing home nursing care for their daily insulin treatment versus usual care.
Interventions
DEVICEt:slim X2 with Control-IQ
closed-loop in patients at home for three months
OTHERhome healthcare services
home healthcare services from Air Liquide in patients at home for three months
OTHERusual care for daily insulin treatment
multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring
Sponsors
International Clinical Trials Association
Air Liquide Santé International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selection criteria: * 1\. Male or female patient aged 18 years or older, 2. Type 2 Diabetes diagnosed for at least 6 months with a stable authorized antidiabetic therapeutic regimen for 3 months, 3. Treated with insulin for at least 6 months, 4. Patient with 8.0% ≤ HbA1c \<12.0% within the last 3 months before selection, 5. Patient with a current minimum of 2 daily insulin injections and who would benefit of an optimisation, 6. Patient requiring long term family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring, 7. Total daily insulin dose \< 1.5 U/kg, 8. Patient willing and able to complete the requirements of the study, 9.Patient living with a caregiver or a diabetes care partner, or patient living alone but with a caregiver living nearby who has a telephone and a key to his or her home, 10.Patient living in an area covered by a GSM (Global System for Mobile Communications) network and not considering a trip outside of France or out of an area covered by a GSM network within the planned dates corresponding to the 30 days of the installation of the pump (to cover the open-loop period and first 15 days of the closed-loop period), and the last 20 days of the study. Inclusion Criteria: 1. Patient having demonstrated ability to understand the benefits and harms of the automated insulin delivery system and to continuously and safely wear a CGM (Continuous Glucose Monitor), as per investigator's judgement, 2. Family nurse having demonstrated ability to use the automated insulin delivery system, as per HHP judgement, 3. Patient able to use basic technology such as a cell phone and having demonstrated ability to use the automated insulin delivery system, as per Home Healthcare Provider (HHP) judgment. In case the patient has not demonstrated ability to use the automated insulin delivery system, his (her) caregiver has to demonstrate ability to use basic technology such as a cell phone and the automated insulin delivery system instead as per Home Healthcare Provider (HHP) judgment. The caregiver has to be an adult person able to speak and read French, having demonstrated ability to use the automated insulin delivery system, with no known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. The caregiver must have committed to maintain uninterrupted availability via personal cell phone and to provide assistance to the patient and must be knowledgeable at all times of the participant's location during the day when closed loop is in use. 4. 14 days completed (ie ≥ 70% of the daily data points non missing) CGM data from the selection period (the CGM period may be repeated only once if uncompleted data), 5. Patient covered by healthcare insurance (in accordance with French regulation), 6. Patient who has received verbal and written information about the study and who signed the informed consent form before any study related procedure. 7. Patient under curatorship must have received the agreement of their legal guardian to participate to the study.
Exclusion criteria
1. Pregnant or breastfeeding woman, 2. Patient who experienced a severe hypoglycaemic event having led to a hospitalisation or having required a third party assistance within the past 6 months, 3. Patient who experienced a diabetic ketoacidosis within the past 6 months, 4. Patient who has demonstrated a marked decrease in hypoglycaemia perception defined by a Gold score \> 4, 5. Patient who has disabilities which could compromise the compliance to the study, in the investigator's opinion, 6. Patient with severe health impairment resulting in short life expectancy (\< 1 year) as assessed by the investigator, 7. Patient participating in another interventional or observational clinical trial or who participated in another interventional clinical trial within 30 days before selection, 8. Patient known allergy to any component of the automated insulin delivery system compounds, 9. Proliferative retinopathy (assessed with a fundus examination or retinal photography performed within 6 months before selection or before the randomisation at the latest) with visual impairment which could compromise the safety of rapid glucose control normalisation and the compliance to the study, 10. Planned initiation of a treatment that would impact the blood glucose levels (such as steroids) during the study period, 11. Patient deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency situation. 12. Lack of effective contraception in women of childbearing potential, 13. Subject with a history of hearing or vision impairment hindering perception of glucose display and alarms (as this point is a contra-indication stated in the user's manual of the investigational medical device), 14. Severe impairment of renal function (Creatinine Clearance \< 30 mL/min), 15. Patient on dialysis (as the user's manual of Dexcom G6 states that G6 readings may be inaccurate in this population) 16. Conditions which may increase the risk of induced hypoglycemia as per the investigator's judgment, 17. lnpatient psychiatric treatment in the past 6 months, 18. Current or recent abuse of alcohol or recreational drugs, 19. Patients that have frequent exposure to magnetic resonance imaging (MRl), computed tomography (CT) scan, or high frequency electrical heat (diathermy) treatment (as this point is a contra-indication stated in the user's manual of the investigational medical device and Dexcom G6
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) | From days 70 to 90 | Time In Range, defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording from days 70 to 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) During Nocturnal Period | At baseline and From days 70 to 90 | Time in range during nocturnal period (00.00-05.59), defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
| Time Above Range (TAR) (Above 180 mg/dL) | At baseline and From days 70 to 90 | Time above target range defined as the percentage of time spent with CGM glucose measurements \>180 mg/dL (10.0 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
| Time Above Range (TAR) (Above 250 mg/dL) | At baseline and From days 70 to 90 | Time above target range defined as the percentage of time spent with CGM glucose measurements ≥250 mg/dL (13.9 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
| Time Below Range (TBR) (Below 70 mg/dL) | At baseline and From days 70 to 90 | Time below target range, defined as the percentage of time spent with CGM glucose measurements \<70 mg/dL (3.9 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
| Time in Range (TIR) During Diurnal Period | At baseline and From days 70 to 90 | Time in range during diurnal period (06.00-23.59), defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
| Glucose Variability (% CV Coefficient of Variation) | At baseline and From days 70 to 90 | Glucose variability assessed by coefficient of glucose variation (% CV) calculated by dividing the Standard Deviation (SD) by the corresponding mean of the CGM glucose measurements during the last 14 days at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
| HbA1c | On day 0 and day 90 | Blood glycated Haemoglobin A1c (HbA1c) value assayed in % at initiation visit (day 0) and at day 90 |
| Total Daily Insulin Dose | At selection (baseline) and study end (day 90) visits | Total daily insulin dose (expressed in IU/day) calculated as the sum of daily dose of insulin injections recorded by investigators whether basal, bolus or premix at selection (baseline) and study end (planned on day 90) visits |
| Body Weight | At initiation (day 0) and study end (day 90) visits | Body weight (expressed in kg) recorded by investigators at initiation (day 0) and study end (planned on day 90) visits |
| Time Below Range (TBR) (Below 54 mg/dL) | At baseline and From days 70 to 90 | Time below target range, defined as the percentage of time spent with CGM glucose measurements \<54 mg/dL (3.0 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90 |
Countries
France
Participant flow
Recruitment details
A total of 43 patients were enrolled from 8 centres in one country (France). Among them, 30 patients were randomized, 15 in each study group. Following randomization in the experimental intervention group, one patient withdrew consent before insulin pump installation and effective start of study follow-up. First Patient Enrolled: December 30, 2019 - Last Patient Completed: May 30, 2022
Participants by arm
| Arm | Count |
|---|---|
| Usual Care multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring
usual care for daily insulin treatment: multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring | 15 |
| Closed-loop and Home Care Services automated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services
t:slim X2 with Control-IQ: closed-loop in patients at home for three months
home healthcare services: home healthcare services from Air Liquide subsidiaries in patients at home for three months | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion criterion found the day after initiation visit | 1 | 0 |
| Overall Study | Lack of complance to study procedures and less than 14 days on closed-loop | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Closed-loop and Home Care Services | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Continuous | 69.7 years STANDARD_DEVIATION 10.3 | 69.3 years STANDARD_DEVIATION 6.7 | 69.5 years STANDARD_DEVIATION 8.6 |
| Body Mass Index | 35.62 kg/m^2 STANDARD_DEVIATION 6.51 | 32.26 kg/m^2 STANDARD_DEVIATION 4.33 | 34.00 kg/m^2 STANDARD_DEVIATION 5.73 |
| HbA1c | 9.25 percentage of blood glycated haemoglobin STANDARD_DEVIATION 1.04 | 8.98 percentage of blood glycated haemoglobin STANDARD_DEVIATION 1.17 | 9.12 percentage of blood glycated haemoglobin STANDARD_DEVIATION 1.09 |
| Number of daily insulin injections, basal | 1.0 number of injections STANDARD_DEVIATION 0 | 1.1 number of injections STANDARD_DEVIATION 0.4 | 1.1 number of injections STANDARD_DEVIATION 0.3 |
| Number of daily insulin injections, bolus | 2.7 number of injections STANDARD_DEVIATION 0.6 | 2.9 number of injections STANDARD_DEVIATION 0.3 | 2.8 number of injections STANDARD_DEVIATION 0.5 |
| Patient on concomitant treatment for cardiovascular disease | 14 Participants | 14 Participants | 28 Participants |
| Patient on glucagon-like peptide-1 analogues | 6 Participants | 4 Participants | 10 Participants |
| Patient on metformin | 9 Participants | 6 Participants | 15 Participants |
| Patient previously using continuous glucose monitoring | 8 Participants | 5 Participants | 13 Participants |
| Patient with at least one cardiovascular comorbidity | 12 Participants | 13 Participants | 25 Participants |
| Patient with at least one concomitant blood glucose lowering drug | 12 Participants | 8 Participants | 20 Participants |
| Patient with at least one concomitant cardiac disorder | 5 Participants | 5 Participants | 10 Participants |
| Patient with at least one diabetes-related comorbidity | 8 Participants | 9 Participants | 17 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 15 participants | 14 participants | 29 participants |
| Sex: Female, Male Female | 13 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 9 Participants |
| Time since insulin therapy onset | 9.39 years STANDARD_DEVIATION 8.03 | 8.99 years STANDARD_DEVIATION 10.19 | 9.20 years STANDARD_DEVIATION 8.97 |
| Time since Type 2 Diabetes diagnosis | 16.97 years STANDARD_DEVIATION 9.05 | 20.39 years STANDARD_DEVIATION 12.28 | 18.62 years STANDARD_DEVIATION 10.67 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 7 / 15 | 9 / 14 |
| serious Total, serious adverse events | 2 / 15 | 5 / 14 |
Outcome results
Primary
Time in Range (TIR)
Time In Range, defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording from days 70 to 90
Time frame: From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Time in Range (TIR) | 36.61 percentage of time | Standard Deviation 21.99 |
| Closed-loop and Home Care Services | Time in Range (TIR) | 63.03 percentage of time | Standard Deviation 9.41 |
p-value: <0.00195% CI: [15, 39.8]ANCOVA
Secondary
Body Weight
Body weight (expressed in kg) recorded by investigators at initiation (day 0) and study end (planned on day 90) visits
Time frame: At initiation (day 0) and study end (day 90) visits
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Body Weight | At initiation visit | 92.10 kg | Standard Deviation 17.29 |
| Usual Care | Body Weight | At study end visit | 91.34 kg | Standard Deviation 17.81 |
| Closed-loop and Home Care Services | Body Weight | At initiation visit | 86.05 kg | Standard Deviation 20.87 |
| Closed-loop and Home Care Services | Body Weight | At study end visit | 87.66 kg | Standard Deviation 21.07 |
p-value: 0.0895% CI: [-0.4, 6.1]ANCOVA
Secondary
Glucose Variability (% CV Coefficient of Variation)
Glucose variability assessed by coefficient of glucose variation (% CV) calculated by dividing the Standard Deviation (SD) by the corresponding mean of the CGM glucose measurements during the last 14 days at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Glucose Variability (% CV Coefficient of Variation) | At baseline | 28.22 percentage of coefficient of variation | Standard Deviation 7.34 |
| Usual Care | Glucose Variability (% CV Coefficient of Variation) | From days 70 to 90 | 28.22 percentage of coefficient of variation | Standard Deviation 3.86 |
| Closed-loop and Home Care Services | Glucose Variability (% CV Coefficient of Variation) | At baseline | 29.45 percentage of coefficient of variation | Standard Deviation 5 |
| Closed-loop and Home Care Services | Glucose Variability (% CV Coefficient of Variation) | From days 70 to 90 | 31.51 percentage of coefficient of variation | Standard Deviation 5.69 |
p-value: 0.0695% CI: [-0.2, 7.6]ANCOVA
Secondary
HbA1c
Blood glycated Haemoglobin A1c (HbA1c) value assayed in % at initiation visit (day 0) and at day 90
Time frame: On day 0 and day 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | HbA1c | On day 0 | 9.16 percentage of glycated haemoglobin | Standard Deviation 1.01 |
| Usual Care | HbA1c | On day 90 | 8.79 percentage of glycated haemoglobin | Standard Deviation 1.01 |
| Closed-loop and Home Care Services | HbA1c | On day 0 | 9.03 percentage of glycated haemoglobin | Standard Deviation 1.31 |
| Closed-loop and Home Care Services | HbA1c | On day 90 | 7.42 percentage of glycated haemoglobin | Standard Deviation 0.64 |
p-value: <0.00195% CI: [-1.9, -0.7]ANCOVA
Secondary
Time Above Range (TAR) (Above 180 mg/dL)
Time above target range defined as the percentage of time spent with CGM glucose measurements \>180 mg/dL (10.0 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Time Above Range (TAR) (Above 180 mg/dL) | At baseline | 60.43 percentage of time | Standard Deviation 23.73 |
| Usual Care | Time Above Range (TAR) (Above 180 mg/dL) | From days 70 to 90 | 62.69 percentage of time | Standard Deviation 22.91 |
| Closed-loop and Home Care Services | Time Above Range (TAR) (Above 180 mg/dL) | At baseline | 64.59 percentage of time | Standard Deviation 21.54 |
| Closed-loop and Home Care Services | Time Above Range (TAR) (Above 180 mg/dL) | From days 70 to 90 | 36.14 percentage of time | Standard Deviation 8.52 |
p-value: <0.00195% CI: [-40.5, -15]ANCOVA
Secondary
Time Above Range (TAR) (Above 250 mg/dL)
Time above target range defined as the percentage of time spent with CGM glucose measurements ≥250 mg/dL (13.9 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Time Above Range (TAR) (Above 250 mg/dL) | At baseline | 30.21 percentage of time | Standard Deviation 28.35 |
| Usual Care | Time Above Range (TAR) (Above 250 mg/dL) | From days 70 to 90 | 28.50 percentage of time | Standard Deviation 22.35 |
| Closed-loop and Home Care Services | Time Above Range (TAR) (Above 250 mg/dL) | At baseline | 31.76 percentage of time | Standard Deviation 23.37 |
| Closed-loop and Home Care Services | Time Above Range (TAR) (Above 250 mg/dL) | From days 70 to 90 | 9.12 percentage of time | Standard Deviation 6.13 |
p-value: 0.00395% CI: [-32.4, -7.9]ANCOVA
Secondary
Time Below Range (TBR) (Below 54 mg/dL)
Time below target range, defined as the percentage of time spent with CGM glucose measurements \<54 mg/dL (3.0 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Time Below Range (TBR) (Below 54 mg/dL) | At baseline | 0.14 percentage of time | Standard Deviation 0.29 |
| Usual Care | Time Below Range (TBR) (Below 54 mg/dL) | From days 70 to 90 | 0.17 percentage of time | Standard Deviation 0.42 |
| Closed-loop and Home Care Services | Time Below Range (TBR) (Below 54 mg/dL) | At baseline | 0.59 percentage of time | Standard Deviation 1.59 |
| Closed-loop and Home Care Services | Time Below Range (TBR) (Below 54 mg/dL) | From days 70 to 90 | 0.18 percentage of time | Standard Deviation 0.46 |
p-value: 0.8495% CI: [-0.3, 0.4]ANCOVA
Secondary
Time Below Range (TBR) (Below 70 mg/dL)
Time below target range, defined as the percentage of time spent with CGM glucose measurements \<70 mg/dL (3.9 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Time Below Range (TBR) (Below 70 mg/dL) | At baseline | 0.65 percentage of time | Standard Deviation 1.08 |
| Usual Care | Time Below Range (TBR) (Below 70 mg/dL) | From days 70 to 90 | 0.70 percentage of time | Standard Deviation 1.27 |
| Closed-loop and Home Care Services | Time Below Range (TBR) (Below 70 mg/dL) | At baseline | 0.98 percentage of time | Standard Deviation 1.64 |
| Closed-loop and Home Care Services | Time Below Range (TBR) (Below 70 mg/dL) | From days 70 to 90 | 0.83 percentage of time | Standard Deviation 1.47 |
p-value: 0.7995% CI: [-1, 1.3]ANCOVA
Secondary
Time in Range (TIR) During Diurnal Period
Time in range during diurnal period (06.00-23.59), defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Time in Range (TIR) During Diurnal Period | At baseline | 37.48 percentage of time | Standard Deviation 23.46 |
| Usual Care | Time in Range (TIR) During Diurnal Period | From days 70 to 90 | 36.96 percentage of time | Standard Deviation 20.57 |
| Closed-loop and Home Care Services | Time in Range (TIR) During Diurnal Period | At baseline | 34.30 percentage of time | Standard Deviation 21.6 |
| Closed-loop and Home Care Services | Time in Range (TIR) During Diurnal Period | From days 70 to 90 | 60.19 percentage of time | Standard Deviation 10.96 |
p-value: <0.00195% CI: [10.6, 35.5]ANCOVA
Secondary
Time in Range (TIR) During Nocturnal Period
Time in range during nocturnal period (00.00-05.59), defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Time in Range (TIR) During Nocturnal Period | At baseline | 43.20 percentage of time | Standard Deviation 31.23 |
| Usual Care | Time in Range (TIR) During Nocturnal Period | From days 70 to 90 | 35.56 percentage of time | Standard Deviation 30.18 |
| Closed-loop and Home Care Services | Time in Range (TIR) During Nocturnal Period | At baseline | 34.82 percentage of time | Standard Deviation 25.24 |
| Closed-loop and Home Care Services | Time in Range (TIR) During Nocturnal Period | From days 70 to 90 | 71.56 percentage of time | Standard Deviation 15.04 |
p-value: <0.00195% CI: [25.8, 55.8]ANCOVA
Secondary
Total Daily Insulin Dose
Total daily insulin dose (expressed in IU/day) calculated as the sum of daily dose of insulin injections recorded by investigators whether basal, bolus or premix at selection (baseline) and study end (planned on day 90) visits
Time frame: At selection (baseline) and study end (day 90) visits
Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Total Daily Insulin Dose | At selection visit | 80.3 IU/day | Standard Deviation 39.5 |
| Usual Care | Total Daily Insulin Dose | At study end visit | 111.7 IU/day | Standard Deviation 72.4 |
| Closed-loop and Home Care Services | Total Daily Insulin Dose | At selection visit | 66.8 IU/day | Standard Deviation 39.2 |
| Closed-loop and Home Care Services | Total Daily Insulin Dose | At study end visit | 80.6 IU/day | Standard Deviation 61.8 |
p-value: 0.5295% CI: [-78.2, 41.2]ANCOVA