Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes: a Randomized Controlled Trial vs Usual Care

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Device: t:slim X2 with Control-IQ
* Other: home healthcare services
* Other: usual care for daily insulin treatment


Participation Criteria
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Eligibility Criteria
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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, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: closed-loop and home care services<br>automated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services | Device: t:slim X2 with Control-IQ<br>* closed-loop in patients at home for three months<br>Other: home healthcare services<br>* home healthcare services from Air Liquide in patients at home for three months<br>|
| Active Comparator: usual care<br>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<br>* multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | At baseline and From days 70 to 90 | 
| 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. | At baseline and From days 70 to 90 | 
| 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. | At baseline and From days 70 to 90 | 
| 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. | At baseline and From days 70 to 90 | 
| 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. | At baseline and From days 70 to 90 | 
| 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. | At baseline and From days 70 to 90 | 
| HbA1c | Blood glycated Haemoglobin A1c (HbA1c) value assayed in % at initiation visit (day 0) and at day 90 | On day 0 and day 90 | 
| 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 and study end visits. | At selection and study end visits | 
| Body Weight | Body weight (expressed in kg) recorded by investigators at initiation and study end visits. | At initiation and study end visits |