Evaluation of a Closed-loop Insulin Delivery System at Ho... | NCT04233229

Status Module

Name	Class
International Clinical Trials Association	OTHER

Label	Type	Description	Intervention Names
closed-loop and home care services	Experimental	automated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services	Device: t:slim X2 with Control-IQ Other: home healthcare services
usual care	Active Comparator	multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring	Other: usual care for daily insulin treatment

Name	Type	Description	Arm Group Labels	Other Names
t:slim X2 with Control-IQ	Device	closed-loop in patients at home for three months	closed-loop and home care services

Measure	Description	Time Frame
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	From days 70 to 90

Measure	Description	Time Frame
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	At baseline and From days 70 to 90

Eligibility Module

Eligibility 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:

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,
Family nurse having demonstrated ability to use the automated insulin delivery system, as per HHP judgement,
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.
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),
Patient covered by healthcare insurance (in accordance with French regulation),
Patient who has received verbal and written information about the study and who signed the informed consent form before any study related procedure.
Patient under curatorship must have received the agreement of their legal guardian to participate to the study.

Exclusion Criteria:

Pregnant or breastfeeding woman,
Patient who experienced a severe hypoglycaemic event having led to a hospitalisation or having required a third party assistance within the past 6 months,
Patient who experienced a diabetic ketoacidosis within the past 6 months,
Patient who has demonstrated a marked decrease in hypoglycaemia perception defined by a Gold score > 4,
Patient who has disabilities which could compromise the compliance to the study, in the investigator's opinion,
Patient with severe health impairment resulting in short life expectancy (< 1 year) as assessed by the investigator,
Patient participating in another interventional or observational clinical trial or who participated in another interventional clinical trial within 30 days before selection,
Patient known allergy to any component of the automated insulin delivery system compounds,
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,
Planned initiation of a treatment that would impact the blood glucose levels (such as steroids) during the study period,
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.
Lack of effective contraception in women of childbearing potential,
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),
Severe impairment of renal function (Creatinine Clearance < 30 mL/min),
Patient on dialysis (as the user's manual of Dexcom G6 states that G6 readings may be inaccurate in this population)
Conditions which may increase the risk of induced hypoglycemia as per the investigator's judgment,
lnpatient psychiatric treatment in the past 6 months,
Current or recent abuse of alcohol or recreational drugs,
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

Name	Affiliation	Role
Yves REZNIK, Pr	University Hospital, Caen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Brest		Brest	Brittany Region	29609	France
CHU Rouen

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 4, 2025

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00015 BG00114 BG00229

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG00036.61± 21.99 OG00163.03± 9.41

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<.001	Study group effect	Adjusted means difference	27.4	Standard Error of the Mean	6.0	2-Sided	95	15.0	39.8			Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.		Superiority	Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)

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

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

Posted

Mean

Standard Deviation

percentage of time

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

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

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

Posted

Mean

Standard Deviation

percentage of time

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

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

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

Posted

Mean

Standard Deviation

percentage of time

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

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

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

Posted

Mean

Standard Deviation

percentage of time

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

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

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

Posted

Mean

Standard Deviation

percentage of time

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

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

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

Posted

Mean

Standard Deviation

percentage of time

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

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

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

Posted

Mean

Standard Deviation

percentage of coefficient of variation

At baseline and From days 70 to 90

ID	Title	Description
OG000	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
OG001	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

Secondary

HbA1c

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

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

Posted

Mean

Standard Deviation

percentage of glycated haemoglobin

On day 0 and day 90

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

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

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

Posted

Mean

Standard Deviation

IU/day

At selection (baseline) and study end (day 90) visits

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Body Weight

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

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

Posted

Mean

Standard Deviation

At initiation (day 0) and study end (day 90) visits

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected14 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected14 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Peritumoural oedema	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0017 events5 affected14 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0006 events3 affected15 at risk EG0012 events2 affected14 at risk
Diabetic ketosis	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events4 affected14 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Medical device site haemorrhage	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Eye pain	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected14 at risk
Tremor	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
Device connection issue	Product Issues	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected14 at risk
Medical device site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected14 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	15	2	15	7	15
EG001	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	0	14	5	14	9	14