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

NCT04233229 | Completed Results DMC FDA Device

• 1 other identifier: ALMED-19-003
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 10

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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Time in Range (TIR) During Diurnal Period

  At baseline and From days 70 to 90

• Time in Range (TIR) During Nocturnal Period

  At baseline and From days 70 to 90

• Time Above Range (TAR) (Above 180 mg/dL)

  At baseline and From days 70 to 90

• Time Above Range (TAR) (Above 250 mg/dL)

  At baseline and From days 70 to 90

• Time Below Range (TBR) (Below 70 mg/dL)

  At baseline and From days 70 to 90

Study Arms (2)

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

Interventions

t:slim X2 with Control-IQ DEVICE

closed-loop in patients at home for three months

closed-loop and home care services

home healthcare services OTHER

home healthcare services from Air Liquide in patients at home for three months

closed-loop and home care services

usual care for daily insulin treatment OTHER

multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Air Liquide Santé International: lead
• International Clinical Trials Association: collaborator

Study Sites (10)

CHRU Brest

Brest, Brittany Region, 29609, France

Location

CHU Rouen

Rouen, Normandy, 76230, France

Location

CHU Amiens

Amiens, Picardie, 80054, France

Location

CHU Caen

Caen, 14033, France

Location

Hopital Européen de Marseille

Marseille, 13003, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHRU Nancy-Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

APHP Lariboisière

Paris, Île-de-France Region, 75475, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Marie-Danielle MILCENT / Clinical Project Manager
• Organization: Air Liquide Santé International

fralsi-ctpublication@airliquide.com

+33 (0)1 84 76 42 39

Study Officials

• Yves REZNIK, Pr

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: December 30, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

FR (10)