Completed

CLOSEAP+Closed-loop Insulin Delivery System and Home Healthcare Provider Service for Uncontrolled Type 2 Diabetes

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Study Aim

This study aims to evaluate the effectiveness of a Closed-loop Insulin Delivery System and Home Healthcare Provider Service in managing uncontrolled Type 2 Diabetes, specifically focusing on the increase in Time in Range, which is the percentage of time your blood sugar levels stay within the desired range.

What is being tested

t:slim X2 with Control-IQ

+ home healthcare services

+ usual care for daily insulin treatment

DeviceOther
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: December 2019
See protocol details

Summary

Principal SponsorAir Liquide Santé International
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 30, 2019

Actual date on which the first participant was enrolled.

This study focuses on a special insulin delivery system called a 'closed-loop insulin delivery system' or 'Artificial Pancreas (AP)'. The aim is to help people with Type 2 Diabetes who have poor control over their condition, especially those who need home nursing care for their daily insulin treatment. The study seeks to understand if this system, when combined with personalized home healthcare services, can improve blood sugar control, lower the risk of complications, enhance patients' quality of life, and reduce healthcare costs compared to usual care. Participants in this study will use the Artificial Pancreas system at home for a certain period. The main goal is to measure the 'Time in Range' (TIR), which is the percentage of time the blood sugar level stays within a healthy range (70-180 mg/dL or 3.9-10.0 mmol/L). This will be tracked using a continuous glucose monitoring system during the last 14 days of the study, from days 70 to 90.

Official TitleEvaluation 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
NCT04233229
Principal SponsorAir Liquide Santé International
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

43 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

19 exclusion criteria prevent from participating
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,
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
automated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

CHRU Brest

Brest, FranceOpen CHRU Brest in Google Maps
Suspended

CHU Rouen

Rouen, France
Suspended

CHU Amiens

Amiens, France
Suspended

CHU Caen

Caen, France
Completed10 Study Centers