Clinical trial NCT04233229: Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: International Clinical Trials Association
First posted: 2020-01-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: OTHER

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.


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:

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

Primary outcomes:
measure: Time in Range (TIR)
timeFrame: From days 70 to 90
Secondary outcomes:
measure: Time in Range (TIR) During Diurnal Period
timeFrame: At baseline and From days 70 to 90
measure: Time in Range (TIR) During Nocturnal Period
timeFrame: At baseline and From days 70 to 90
measure: Time Above Range (TAR) (Above 180 mg/dL)
timeFrame: At baseline and From days 70 to 90
measure: Time Above Range (TAR) (Above 250 mg/dL)
timeFrame: At baseline and From days 70 to 90
measure: Time Below Range (TBR) (Below 70 mg/dL)
timeFrame: At baseline and From days 70 to 90
measure: Time Below Range (TBR) (Below 54 mg/dL)
timeFrame: At baseline and From days 70 to 90
measure: Glucose Variability (% CV Coefficient of Variation)
timeFrame: At baseline and From days 70 to 90
measure: HbA1c
timeFrame: On day 0 and day 90
measure: Total Daily Insulin Dose
timeFrame: At selection (baseline) and study end (day 90) visits
measure: Body Weight
timeFrame: At initiation (day 0) and study end (day 90) visits
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
state: Bretagne
city: Paris
country: France
facility: APHP Lariboisière
state: Ile De France
city: Rouen
country: France
facility: CHU Rouen
state: Normandie
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
city: Caen
country: France
facility: CHU Caen
city: Marseille
country: France
facility: Hopital Européen de Marseille
city: Nantes
country: France
facility: CHU Nantes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Vandoeuvre-les-nancy
country: France
facility: CHRU Nancy-Hôpitaux de Brabois
Study officials:
affiliation: CHU CAEN
name: Yves REZNIK, Pr
role: PRINCIPAL_INVESTIGATOR
References: