Diabetes Type 2CLOSEAP+NCT04233229
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
A study testing home healthcare services in people with Diabetes Type 2, run by Air Liquide Santé International at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- home healthcare services
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 10 sitesFrance
- Study dates
- 30 Dec 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Amiens
Amiens, Picardie, 80054
CHRU Brest
Brest, Brittany Region, 29609
CHU Caen
Caen, 14033
Hopital Européen de Marseille
Marseille, 13003
CHU Nantes
Nantes, 44093
APHP Lariboisière
Paris, Île-de-France Region, 75475
CHU Rouen
Rouen, Normandy, 76230
CHU Strasbourg
Strasbourg, 67091
CHU Toulouse
Toulouse, 31059
CHRU Nancy-Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
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
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
- Being tested
- t:slim X2 with Control-IQ, home healthcare services, usual care for daily insulin treatment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t:slim X2 with Control-IQDevice
closed-loop in patients at home for three months
home healthcare servicesOther
home healthcare services from Air Liquide in patients at home for three months
usual care for daily insulin treatmentOther
multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| closed-loop and home care services | Experimental | automated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services Receives: 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 Receives: Other: usual care for daily insulin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From days 70 to 90
Secondary outcomes (10)
Time in Range (TIR) During Diurnal Period
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
Measured: At baseline and From days 70 to 90
Time in Range (TIR) During Nocturnal Period
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
Measured: At baseline and From days 70 to 90
Time Above Range (TAR) (Above 180 mg/dL)
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
Measured: At baseline and From days 70 to 90
Time Above Range (TAR) (Above 250 mg/dL)
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
Measured: At baseline and From days 70 to 90
Time Below Range (TBR) (Below 70 mg/dL)
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
Measured: At baseline and From days 70 to 90
Time Below Range (TBR) (Below 54 mg/dL)
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
Measured: At baseline and From days 70 to 90
Glucose Variability (% CV Coefficient of Variation)
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
Measured: At baseline and From days 70 to 90
HbA1c
Blood glycated Haemoglobin A1c (HbA1c) value assayed in % at initiation visit (day 0) and at day 90
Measured: On day 0 and day 90
Total Daily Insulin Dose
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
Measured: At selection (baseline) and study end (day 90) visits
Body Weight
Body weight (expressed in kg) recorded by investigators at initiation (day 0) and study end (planned on day 90) visits
Measured: At initiation (day 0) and study end (day 90) visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start30 Dec 2019
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association
- Responsible party
- Sponsor
- Investigators
- Yves REZNIK, Pr, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233229
- Sponsor's protocol ID
- ALMED-19-003
- Acronym
- CLOSEAP+
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2020
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04233229
- Acronym / sponsor ID
- CLOSEAP+ / ALMED-19-003
- Conditions
- Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| closed-loop and home care services | Experimental | Device: t:slim X2 with Control-IQ, Other: home healthcare servicesautomated insulin delivery system (Closed-loop) with tailored Home Healthcare Provider (HHP) services |
| usual care | Active comparator | Other: usual care for daily insulin treatmentmultiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| t:slim X2 with Control-IQclosed-loop in patients at home for three months | Device | closed-loop and home care services |
| home healthcare serviceshome healthcare services from Air Liquide in patients at home for three months | Other | closed-loop and home care services |
| usual care for daily insulin treatmentmultiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring | Other | usual care |
Primary outcome
Time in Range (TIR)
Time frame: 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
10 secondary outcomes
Time in Range (TIR) During Diurnal Period
Time frame: At baseline and From days 70 to 90
Time in Range (TIR) During Nocturnal Period
Time frame: At baseline and From days 70 to 90
Time Above Range (TAR) (Above 180 mg/dL)
Time frame: At baseline and From days 70 to 90
Time Above Range (TAR) (Above 250 mg/dL)
Time frame: At baseline and From days 70 to 90
Time Below Range (TBR) (Below 70 mg/dL)
Time frame: At baseline and From days 70 to 90
Time Below Range (TBR) (Below 54 mg/dL)
Time frame: At baseline and From days 70 to 90
Glucose Variability (% CV Coefficient of Variation)
Time frame: At baseline and From days 70 to 90
HbA1c
Time frame: On day 0 and day 90
Total Daily Insulin Dose
Time frame: At selection (baseline) and study end (day 90) visits
Body Weight
Time frame: At initiation (day 0) and study end (day 90) visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves REZNIK, Pr principal investigator
University Hospital, Caen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home healthcare services in people with Diabetes Type 2, run by Air Liquide Santé International at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (TIR) (time frame: From days 70 to 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.