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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 Patients (T2D)

NCT04233229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-04-20

Study results available
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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

Interventions

DEVICE

t:slim X2 with Control-IQ

closed-loop in patients at home for three months

OTHER

home healthcare services

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

OTHER

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

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Air Liquide Santé International

    lead INDUSTRY

Principal Investigators

  • Yves REZNIK, Pr · CHU CAEN

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2022-05-30
Completion
2022-05-30
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233229 on ClinicalTrials.gov