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

Not Applicable

Completed

Conditions: Diabetes Type 2

Interventions: Other: home healthcare services
Other: usual care for daily insulin treatment

Registration Number: NCT04233229

Lead Sponsor: Air Liquide Santé International

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
closed-loop and home care services	home healthcare services	automated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services
usual care	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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
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

Trial Locations

Locations (10): CHU Nantes
🇫🇷
Nantes, France
CHRU Nancy-Hôpitaux de Brabois
🇫🇷
Vandoeuvre-les-nancy, France
CHRU Brest
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Brest, Bretagne, France
CHU Rouen
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Rouen, Normandie, France
APHP Lariboisière
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Paris, Ile De France, France
CHU Amiens
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Amiens, Picardie, France
CHU Caen
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Caen, France
Hopital Européen de Marseille
🇫🇷
Marseille, France
CHU Strasbourg
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Strasbourg, France
CHU Toulouse
🇫🇷
Toulouse, France