Quality of LifeIMPLIQUENCT04939766
Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life
A study testing Activation of a closed loop device in an insulin pump device with GCM in people with Quality of Life and Burden, Dependency, run by VitalAire.
Trial summary
The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Quality of Life, Burden, Dependency
- What is being tested?
- Activation of a closed loop device in an insulin pump device with GCM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetic patients undergoing a CSII therapy for at least 6 months and using Tandem t:slim X2 for at least 4 weeks.
- Patient using CGM for 6 months including Dexcon G6 for at least 4 weeks.
- Eligible patient (according to French Society recommendations) for activation of the closed loop
- Informed Patient accepting the computer processing of their medical data.
- Patient correctly completing the 2 main self questionnaires
- Patient with HbA1c below 11%
Who cannot join
- Pregnancy or Lactation during the study
- Patient with a diabetic retinopathy not controlled by laser
- Patient suffering from a disease or undertaking a treatment altering glucose metabolism
Trial locations and contacts
No sites are listed yet.
Cecile CABALLOL contact
About this study
Official title: Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life in Type 1 Diabetic Patients With Continuous Glucose Monitoring (CGM)
The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes.
Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability.
Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII.
Read the detailed description
This cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (CSII) with Continuous Glucose Monitoring (GCM). After inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. During this 20 days' period, patients should complete all the self-questionnaires.
Then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months.
The 3 phone contacts are mainly planned, as recommended in French guidelines, to ensure the good use of the device and to detect or prevent any unexpected events.
The 2 visits at 3 and 6 months, are planned to assess the glycemic variability using Continuous Glucose Monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (Quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires.
Main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability.
- Conditions
- Quality of Life, Burden, Dependency
- Being tested
- Activation of a closed loop device in an insulin pump device with GCM
- Keywords
- Continuous subcutaneous insulin infusion, Diabetes type 1, Closed loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation of a closed loop device in an insulin pump device with GCMDevice
After a run-in period of 20 days to co,firm eligibility, the closed loop is activated and patients are followed for 6 months by their diabetologists.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetic patients under CSII eligible for closed loop use | Other | Diabetic patients age 13 or above under CSII with continuous glucose monitoring matching eligibility criteria for the use of a closed loop during a 6 months period. During the study, 4 physical appointments with a diabetologist and 3 phone contacts are anticipated. Receives: Device: Activation of a closed loop device in an insulin pump device with GCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life following activation of closed loop
Validated self questionnaire : Audit of Diabetes dependant quality of life (ADQQoL) with 19 items Lower scores reflect worsening quality of life
Measured: Score comparison between Baseline and 6 months after activation of closed loop
Change in burden of diabetes following activation of closed loop
Validated self questionnaire : Problem Areas s in Diabetes (PAID) with 20 items. Higher scores reflect greater emotional distress.
Measured: Score comparison between Baseline and 6 months after activation of closed loop
Secondary outcomes (2)
Perception of patients
Different validated self questionnaires on well-being, Fatigue, Anxiety and Depression, Physical activity, Sleep, Fear of hypoglycemia and personality.
Measured: Before and 6 months after activation of closed loop
Glycemic variability
Collection of symptomatic hypoglycemic and hyperglycemic events. Data from GCM including time in range, time above range, time below range and glycemic variability coefficient.
Measured: Before, 3 months and 6 months after activation of closed loop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal cohort study with a 6 months follow-up evaluation evaluating in type 1 diabetic patients under CSII the impact of closed loop use on quality of life and burden using different validated self questionnaires.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VitalAire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Reznik, MD PHD, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939766
- Sponsor's protocol ID
- 2021-A00005-36
- Acronym
- IMPLIQUE
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tubiana-Rufi N, Schaepelynck P, Franc S, Chaillous L, Joubert M, Renard E, Reznik Y, Abettan C, Bismuth E, Beltrand J, Bonnemaison E, Borot S, Charpentier G, Delemer B, Desserprix A, Durain D, Farret A, Filhol N, Guerci B, Guilhem I, Guillot C, Jeandidier N, Lablanche S, Leroy R, Melki V, Munch M, Penfornis A, Picard S, Place J, Riveline JP, Serusclat P, Sola-Gazagnes A, Thivolet C, Hanaire H, Benhamou PY; SFD SFD Paramedical SFE SFEDP AJD FFD FENAREDIAM and CNP-EDN. Practical implementation of automated closed-loop insulin delivery: A French position statement. Diabetes Metab. 2021 May;47(3):101206. doi: 10.1016/j.diabet.2020.10.004. Epub 2020 Nov 2.
PubMed 33152550Julla JB, Jacquemier P, Bonnemaison E, Fagherazzi G, Hanaire H, Bellicar Schaepelynck P, Mihaileanu M, Renard E, Reznik Y, Riveline JP. Assessment of the Impact of Subcutaneous Catheter Change on Glucose Control in Patients with Type 1 Diabetes Treated by Insulin Pump in Open- and Closed-Loop Modes. Diabetes Technol Ther. 2024 Jul;26(7):442-448. doi: 10.1089/dia.2023.0568. Epub 2024 Mar 7.
PubMed 38350126
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life in Type 1 Diabetic Patients With Continuous Glucose Monitoring (CGM)
- ClinicalTrials.gov ID
- NCT04939766
- Acronym / sponsor ID
- IMPLIQUE / 2021-A00005-36
- Conditions
- Quality of Life, Burden, Dependency
- Keywords
- Continuous subcutaneous insulin infusion, Diabetes type 1, Closed loop
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- VitalAireIndustry (pharma, biotech, devices)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes.
Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability.
Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII.
Detailed description
This cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (CSII) with Continuous Glucose Monitoring (GCM). After inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. During this 20 days' period, patients should complete all the self-questionnaires.
Then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months.
The 3 phone contacts are mainly planned, as recommended in French guidelines, to ensure the good use of the device and to detect or prevent any unexpected events.
The 2 visits at 3 and 6 months, are planned to assess the glycemic variability using Continuous Glucose Monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (Quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires.
Main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal cohort study with a 6 months follow-up evaluation evaluating in type 1 diabetic patients under CSII the impact of closed loop use on quality of life and burden using different validated self questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetic patients under CSII eligible for closed loop use | Other | Device: Activation of a closed loop device in an insulin pump device with GCMDiabetic patients age 13 or above under CSII with continuous glucose monitoring matching eligibility criteria for the use of a closed loop during a 6 months period. During the study, 4 physical appointments with a diabetologist and 3 phone contacts are anticipated. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetic patients undergoing a CSII therapy for at least 6 months and using Tandem t:slim X2 for at least 4 weeks.
- Patient using CGM for 6 months including Dexcon G6 for at least 4 weeks.
- Eligible patient (according to French Society recommendations) for activation of the closed loop
- Informed Patient accepting the computer processing of their medical data.
- Patient correctly completing the 2 main self questionnaires
Key exclusion criteria (3 listed)
- Pregnancy or Lactation during the study
- Patient with a diabetic retinopathy not controlled by laser
- Patient suffering from a disease or undertaking a treatment altering glucose metabolism
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 |
|---|---|---|
| Activation of a closed loop device in an insulin pump device with GCMAfter a run-in period of 20 days to co,firm eligibility, the closed loop is activated and patients are followed for 6 months by their diabetologists. | Device | Type 1 diabetic patients under CSII eligible for closed loop use |
Primary outcome
Change in Quality of life following activation of closed loop
Time frame: Score comparison between Baseline and 6 months after activation of closed loop
Validated self questionnaire : Audit of Diabetes dependant quality of life (ADQQoL) with 19 items Lower scores reflect worsening quality of life
Change in burden of diabetes following activation of closed loop
Time frame: Score comparison between Baseline and 6 months after activation of closed loop
Validated self questionnaire : Problem Areas s in Diabetes (PAID) with 20 items. Higher scores reflect greater emotional distress.
2 secondary outcomes
Perception of patients
Time frame: Before and 6 months after activation of closed loop
Glycemic variability
Time frame: Before, 3 months and 6 months after activation of closed loop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Background: PubMed 33152550Tubiana-Rufi N, Schaepelynck P, Franc S, Chaillous L, Joubert M, Renard E, Reznik Y, Abettan C, Bismuth E, Beltrand J, Bonnemaison E, Borot S, Charpentier G, Delemer B, Desserprix A, Durain D, Farret A, Filhol N, Guerci B, Guilhem I, Guillot C, Jeandidier N, Lablanche S, Leroy R, Melki V, Munch M, Penfornis A, Picard S, Place J, Riveline JP, Serusclat P, Sola-Gazagnes A, Thivolet C, Hanaire H, Benhamou PY; SFD SFD Paramedical SFE SFEDP AJD FFD FENAREDIAM and CNP-EDN. Practical implementation of automated closed-loop insulin delivery: A French position statement. Diabetes Metab. 2021 May;47(3):101206. doi: 10.1016/j.diabet.2020.10.004. Epub 2020 Nov 2.
- Derived from this study: PubMed 38350126Julla JB, Jacquemier P, Bonnemaison E, Fagherazzi G, Hanaire H, Bellicar Schaepelynck P, Mihaileanu M, Renard E, Reznik Y, Riveline JP. Assessment of the Impact of Subcutaneous Catheter Change on Glucose Control in Patients with Type 1 Diabetes Treated by Insulin Pump in Open- and Closed-Loop Modes. Diabetes Technol Ther. 2024 Jul;26(7):442-448. doi: 10.1089/dia.2023.0568. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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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.
Cecile CABALLOL contact
Yves Reznik, MD PHD study chair
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
A study testing Activation of a closed loop device in an insulin pump device with GCM in people with Quality of Life and Burden, Dependency, run by VitalAire.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle MORRY (0149694515, emmanuelle.morry@vitalaire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life following activation of closed loop (time frame: Score comparison between Baseline and 6 months after activation of closed loop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939766, which also lists 2 linked publications.
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 25 Jun 2021.