Trial Outcomes & Findings for Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D) (NCT NCT04233229)

NCT ID: NCT04233229

Last Updated: 2025-04-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: From days 70 to 90
• Results posted on: 2025-04-20

Participant Flow

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

Participant milestones

Measure	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	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
Overall Study STARTED	15	14
Overall Study COMPLETED	14	11
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	0	1
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

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Usual Care n=15 Participants 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	Closed-loop and Home Care Services n=14 Participants 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	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=14 Participants	0 Participants n=29 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=15 Participants	2 Participants n=14 Participants	7 Participants n=29 Participants
Age, Categorical >=65 years	10 Participants n=15 Participants	12 Participants n=14 Participants	22 Participants n=29 Participants
Age, Continuous	69.7 years STANDARD_DEVIATION 10.3 • n=15 Participants	69.3 years STANDARD_DEVIATION 6.7 • n=14 Participants	69.5 years STANDARD_DEVIATION 8.6 • n=29 Participants
Sex: Female, Male Female	13 Participants n=15 Participants	7 Participants n=14 Participants	20 Participants n=29 Participants
Sex: Female, Male Male	2 Participants n=15 Participants	7 Participants n=14 Participants	9 Participants n=29 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	15 participants n=15 Participants	14 participants n=14 Participants	29 participants n=29 Participants
Body Mass Index	35.62 kg/m^2 STANDARD_DEVIATION 6.51 • n=15 Participants	32.26 kg/m^2 STANDARD_DEVIATION 4.33 • n=14 Participants	34.00 kg/m^2 STANDARD_DEVIATION 5.73 • n=29 Participants
HbA1c	9.25 percentage of blood glycated haemoglobin STANDARD_DEVIATION 1.04 • n=15 Participants	8.98 percentage of blood glycated haemoglobin STANDARD_DEVIATION 1.17 • n=14 Participants	9.12 percentage of blood glycated haemoglobin STANDARD_DEVIATION 1.09 • n=29 Participants
Time since Type 2 Diabetes diagnosis	16.97 years STANDARD_DEVIATION 9.05 • n=15 Participants	20.39 years STANDARD_DEVIATION 12.28 • n=14 Participants	18.62 years STANDARD_DEVIATION 10.67 • n=29 Participants
Time since insulin therapy onset	9.39 years STANDARD_DEVIATION 8.03 • n=15 Participants	8.99 years STANDARD_DEVIATION 10.19 • n=14 Participants	9.20 years STANDARD_DEVIATION 8.97 • n=29 Participants
Number of daily insulin injections, basal	1.0 number of injections STANDARD_DEVIATION 0.0 • n=15 Participants	1.1 number of injections STANDARD_DEVIATION 0.4 • n=14 Participants	1.1 number of injections STANDARD_DEVIATION 0.3 • n=29 Participants
Number of daily insulin injections, bolus	2.7 number of injections STANDARD_DEVIATION 0.6 • n=15 Participants • In the experimental intervention group, 12 patients out of 14 were on concomitant insulin bolus scheme.	2.9 number of injections STANDARD_DEVIATION 0.3 • n=12 Participants • In the experimental intervention group, 12 patients out of 14 were on concomitant insulin bolus scheme.	2.8 number of injections STANDARD_DEVIATION 0.5 • n=27 Participants • In the experimental intervention group, 12 patients out of 14 were on concomitant insulin bolus scheme.
Patient previously using continuous glucose monitoring	8 Participants n=15 Participants	5 Participants n=14 Participants	13 Participants n=29 Participants
Patient with at least one concomitant blood glucose lowering drug	12 Participants n=15 Participants	8 Participants n=14 Participants	20 Participants n=29 Participants
Patient on metformin	9 Participants n=15 Participants	6 Participants n=14 Participants	15 Participants n=29 Participants
Patient on glucagon-like peptide-1 analogues	6 Participants n=15 Participants	4 Participants n=14 Participants	10 Participants n=29 Participants
Patient on concomitant treatment for cardiovascular disease	14 Participants n=15 Participants	14 Participants n=14 Participants	28 Participants n=29 Participants
Patient with at least one cardiovascular comorbidity	12 Participants n=15 Participants	13 Participants n=14 Participants	25 Participants n=29 Participants
Patient with at least one concomitant cardiac disorder	5 Participants n=15 Participants	5 Participants n=14 Participants	10 Participants n=29 Participants
Patient with at least one diabetes-related comorbidity	8 Participants n=15 Participants	9 Participants n=14 Participants	17 Participants n=29 Participants

PRIMARY outcome

Timeframe: From days 70 to 90

Population: Efficacy intention to treat data set: all randomized patients followed-up at least 2 weeks after their randomization

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time in Range (TIR)	36.61 percentage of time Standard Deviation 21.99	63.03 percentage of time Standard Deviation 9.41

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time in Range (TIR) During Diurnal Period At baseline	37.48 percentage of time Standard Deviation 23.46	34.30 percentage of time Standard Deviation 21.60
Time in Range (TIR) During Diurnal Period From days 70 to 90	36.96 percentage of time Standard Deviation 20.57	60.19 percentage of time Standard Deviation 10.96

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time in Range (TIR) During Nocturnal Period At baseline	43.20 percentage of time Standard Deviation 31.23	34.82 percentage of time Standard Deviation 25.24
Time in Range (TIR) During Nocturnal Period From days 70 to 90	35.56 percentage of time Standard Deviation 30.18	71.56 percentage of time Standard Deviation 15.04

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time Above Range (TAR) (Above 180 mg/dL) From days 70 to 90	62.69 percentage of time Standard Deviation 22.91	36.14 percentage of time Standard Deviation 8.52
Time Above Range (TAR) (Above 180 mg/dL) At baseline	60.43 percentage of time Standard Deviation 23.73	64.59 percentage of time Standard Deviation 21.54

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time Above Range (TAR) (Above 250 mg/dL) At baseline	30.21 percentage of time Standard Deviation 28.35	31.76 percentage of time Standard Deviation 23.37
Time Above Range (TAR) (Above 250 mg/dL) From days 70 to 90	28.50 percentage of time Standard Deviation 22.35	9.12 percentage of time Standard Deviation 6.13

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time Below Range (TBR) (Below 70 mg/dL) At baseline	0.65 percentage of time Standard Deviation 1.08	0.98 percentage of time Standard Deviation 1.64
Time Below Range (TBR) (Below 70 mg/dL) From days 70 to 90	0.70 percentage of time Standard Deviation 1.27	0.83 percentage of time Standard Deviation 1.47

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Time Below Range (TBR) (Below 54 mg/dL) At baseline	0.14 percentage of time Standard Deviation 0.29	0.59 percentage of time Standard Deviation 1.59
Time Below Range (TBR) (Below 54 mg/dL) From days 70 to 90	0.17 percentage of time Standard Deviation 0.42	0.18 percentage of time Standard Deviation 0.46

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Glucose Variability (% CV Coefficient of Variation) At baseline	28.22 percentage of coefficient of variation Standard Deviation 7.34	29.45 percentage of coefficient of variation Standard Deviation 5.00
Glucose Variability (% CV Coefficient of Variation) From days 70 to 90	28.22 percentage of coefficient of variation Standard Deviation 3.86	31.51 percentage of coefficient of variation Standard Deviation 5.69

SECONDARY outcome

Timeframe: 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

Blood glycated Haemoglobin A1c (HbA1c) value assayed in % at initiation visit (day 0) and at day 90

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
HbA1c On day 0	9.16 percentage of glycated haemoglobin Standard Deviation 1.01	9.03 percentage of glycated haemoglobin Standard Deviation 1.31
HbA1c On day 90	8.79 percentage of glycated haemoglobin Standard Deviation 1.01	7.42 percentage of glycated haemoglobin Standard Deviation 0.64

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Total Daily Insulin Dose At selection visit	80.3 IU/day Standard Deviation 39.5	66.8 IU/day Standard Deviation 39.2
Total Daily Insulin Dose At study end visit	111.7 IU/day Standard Deviation 72.4	80.6 IU/day Standard Deviation 61.8

SECONDARY outcome

Timeframe: 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

Body weight (expressed in kg) recorded by investigators at initiation (day 0) and study end (planned on day 90) visits

Outcome measures

Measure	Usual Care n=14 Participants 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	Closed-loop and Home Care Services n=11 Participants 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
Body Weight At initiation visit	92.10 kg Standard Deviation 17.29	86.05 kg Standard Deviation 20.87
Body Weight At study end visit	91.34 kg Standard Deviation 17.81	87.66 kg Standard Deviation 21.07

Adverse Events

Usual Care

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Closed-loop and Home Care Services

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=15 participants at risk 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	Closed-loop and Home Care Services n=14 participants at risk 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
Metabolism and nutrition disorders Hyperglycaemia	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Metabolism and nutrition disorders Diabetes mellitus inadequate control	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Cardiac disorders Cardiac failure	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Infections and infestations COVID-19	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	14.3% 2/14 • Number of events 2 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Infections and infestations Sepsis	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Hepatobiliary disorders Cholecystitis acute	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritumoural oedema	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient

Other adverse events

Measure	Usual Care n=15 participants at risk 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	Closed-loop and Home Care Services n=14 participants at risk 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
Metabolism and nutrition disorders Hyperglycaemia	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	35.7% 5/14 • Number of events 7 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Metabolism and nutrition disorders Hypoglycaemia	20.0% 3/15 • Number of events 6 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	14.3% 2/14 • Number of events 2 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Metabolism and nutrition disorders Diabetic ketosis	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
General disorders Oedema peripheral	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	28.6% 4/14 • Number of events 4 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
General disorders General physical health deterioration	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
General disorders Medical device site haemorrhage	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Infections and infestations Pyelonephritis	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Musculoskeletal and connective tissue disorders Flank pain	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Musculoskeletal and connective tissue disorders Osteoarthritis	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Eye disorders Eye pain	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Eye disorders Vision blurred	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Hepatobiliary disorders Hepatic cirrhosis	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Reproductive system and breast disorders Breast pain	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Reproductive system and breast disorders Prostatitis	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Injury, poisoning and procedural complications Contusion	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	0.00% 0/14 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Nervous system disorders Tremor	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Product Issues Device connection issue	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
Infections and infestations COVID-19	6.7% 1/15 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient
General disorders Medical device site pain	0.00% 0/15 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient	7.1% 1/14 • Number of events 1 • From the signature of the informed consent to the study end (planned on day 90) for each participating patient

Additional Information

Marie-Danielle MILCENT / Clinical Project Manager

Air Liquide Santé International

Phone: +33 (0)1 84 76 42 39

Email: fralsi-ctpublication@airliquide.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER