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Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled DT2 (CLOSEAP+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233229
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
International Clinical Trials Association
Information provided by (Responsible Party):
Air Liquide Santé International

Brief Summary:

Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated T2D patients.

A wide acceptance of the 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 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 Type 2 Diabetes needing home nursing care for their daily insulin treatment versus usual care.


Condition or disease Intervention/treatment Phase
Diabete Type 2 Device: t:slim X2 with Control-IQ Other: home healthcare services Other: usual care for daily insulin treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: closed-loop and home care services Device: t:slim X2 with Control-IQ
closed-loop from TANDEM diabetes care in patients at home for three months

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

Active Comparator: usual care 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




Primary Outcome Measures :
  1. time in range [ 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 1.5U/kg, 8. Patient willing and able to complete the requirements of the study, 9. Recent fundus examination (≤3 months) having shown no proliferative retinopathy, 10.Patient not living alone, or having a caregiver living nearby who has a telephone and a key to his or her home, 11.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 30 days of the installation of the "closed-loop" insulin therapy system (or "artificial pancreas" one).

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, as per investigator's judgement,
  2. Patient, family nurse and/or caregiver having demonstrated ability to use the automated insulin delivery system, as per HHP judgement,
  3. 14 days completed (≥ 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),
  4. Patient covered by healthcare insurance (in accordance with French regulation),
  5. Patient who has received verbal and written information about the study and who signed the informed consent form before any study related procedure.

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 and marked decrease in hypoglycaemia perception, based on the investigator's assessment,
  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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233229


Contacts
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Contact: Nathalie NOEL +33624989242 nathalie.noel@airliquide.com
Contact: Véronique CRONE +33613930964 veronique.crone@airliquide.com

Locations
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France
CHU Caen Recruiting
Caen, France, 14033
Contact: Yves REZNIK, Pr    +33 2 31 06 45 87    reznik-y@chu-caen.fr   
Sponsors and Collaborators
Air Liquide Santé International
International Clinical Trials Association
Investigators
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Principal Investigator: Yves REZNIK, Pr CHU Caen

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Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT04233229    
Other Study ID Numbers: ALMED-19-003
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs