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| Name | Class |
|---|---|
| Qualees SAS | UNKNOWN |
| CamDiab Ltd | UNKNOWN |
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This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France. The study is conducted among participants with type 1 diabetes (T1D) using the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring (CGM) sensor (the System).
The main objective of the study is to evaluate, under real-life conditions, the impact of the System on glycemic control in participants with T1D after one year of use.
Secondary objectives include assessing participant-reported outcomes, such as quality-of-life, treatment satisfaction, fear of hypoglycemia, and sleep quality, describing complications related to the system, the rate of hybrid closed-loop usage over one year, and analyzing system usage parameters.
The study will involve approximately 125 participants (including 100 adults and 25 minors) across 22 centers in France. Patients will be followed up for 12 months.
This study, called EPICAM-PMCF-G6, is part of a Post-Market Clinical Follow-up (PMCF) requested by the French Health Technology Assessment Committee (CNEDiMTS), following the listing of the System for reimbursement under the national healthcare system in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with type 1 diabetes initiating the hybrid closed-loop system | Participants (adults and minors) with type 1 diabetes (T1D) initiating the mylife CamAPS FX system combined with the Dexcom G6 sensor, under real-life management conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time in Range (TIR) | Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%) | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time in Range (TIR) | Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%) | Baseline and 12 months |
| Change in Time In Tight Range (TITR) | Change in Time In Tight Range (TITR, 70 - 140 mg/dL) (%) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be recruited from 22 French participating centers, which are defined as insulin pump initiation hospital centers according to the definition of the Francophone Diabetic Society.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingo Braun, Dr. | Contact | +41582347132 | clinical-studies@mylife-diabetescare.com |
| Name | Affiliation | Role |
|---|---|---|
| Ingo Braun | mylife Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Recruiting | Amiens | 80054 | France | ||
| Hôtel Dieu-Pédiatrie |
In accordance with the General Data Protection Regulation and French data protection laws the presentation of the results derived from data processing shall under no circumstances allow the direct or indirect identification of individuals participating in the study.
In the event of publication of the study findings in a scientific journal, access to the data by an independent expert - including one appointed by a scientific publisher - shall only be granted through the interface provided or designated by the Data Controller, solely for the purpose of verifying or reproducing the analyses, and exclusively under the conditions defined for secure consultation and data handling. The study is a non-interventional trial.
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| Baseline, 3 and 12 months |
| Change in Time Above Range (TAR) | Change in Time Above Range (TAR, > 250 mg/dL and > 180 mg/dL; for pregnant women: TAR, > 140 mg/dL) (%) | Baseline, 3 months, and 12 months |
| Change in Time Below Range (TBR) | Change in Time Below Range (TBR, < 70 mg/dL and < 54 mg/dL; for pregnant women: TBR, < 63 mg/dL and < 54 mg/dL) (%) | Baseline, 3 and 12 months |
| Change in average glucose levels from CGM sensor data | Change in average glucose levels from CGM sensor data (mg/dL) | Baseline, 3 months and 12 months |
| Change in Standard Deviation (SD) of glucose | Change in Standard Deviation (SD) of glucose | Baseline, 3 months and 12 months |
| Change in Coefficient of Variation (CV) of glucose | Change in Coefficient of Variation (CV) of glucose derived from CGM sensor data (%) | Baseline, 3 months and 12 months |
| Change in Glucose Management Indicator (GMI) | Change in Glucose Management Indicator (GMI) (%) derived from CGM sensor data | Baseline, 3 months and 12 months |
| Change in HbA1c | Change in HbA1c (%) | Baseline, 3 months and 12 months |
| Time in hybrid closed-loop | Time spent in hybrid closed-loop (%) | 3 months and 12 months |
| System usage modalities | Description of evolution rate of advanced features | 3 months and 12 months |
| Change in the PAID questionnaire score | Self-administered questionnaire: Problem Areas In Diabetes (PAID) Following versions will be used: Adult version (18 and above), Teen version (PAID-T) in adolescents aged 12-18 years, and for their parents (P-PAID-T), Children version (PAID-C) in children aged 8-11 years and their parents (P-PAID-C). P-PAID-C will be also used in parents of children aged <8 years. The Problem Areas in Diabetes (PAID) questionnaire assesses diabetes-related emotional distress across patients and caregivers using age- and role-specific versions. The PAID (adults), PAID-T (teens), and PAID-C (children) are self-reported, while P-PAID-T and P-PAID-C are completed by parents of teens and children, respectively. All versions use Likert scales and are typically transformed to a 0-100 score, with higher values indicating greater distress. | Baseline, 3 months and 12 months |
| Change in the DTSQ questionnaire score | Self-administered questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQs) Following versions will be used: Adult version (18 and above), Teen version (DTSQs-Teen) in adolescents aged 13-18 years. For their parents and parents of children aged <13 years, Parent version (DTSQs-Parent) will be used. DTSQQs for adults contains 8 items, DTSQs-Teen has 12 items and DTSQs-Parent has 14 items. The total score of the DTSQs is calculated by summing six items (excluding perceived hypo/hyperglycaemia), each rated 0 to 6, resulting in a total score from 0 to 36, with higher scores indicating better treatment satisfaction. | Baseline, 3 months and 12 months |
| Change in the HFS-II questionnaire score | Self-administered questionnaire Hypoglycemia Fear Survey II (HFS-II). The following versions will be used: Adult version, Children version (HFS-II children) for children aged 6 years and above, Parent version (HFS-II parent) for children aged 8 years and above, and Parent version for children aged <8 years (HFS-II parent of young children). HFS-II consists of items ranging from 0 (never) to 4 (almost always) (9 items in the Adult version, 25 in the Teen version and 26 in the Parent versions). It is composed of two subscales: a Behavior score and a Worry score, with higher scores reflecting greater behavioral or emotional impact. | Baseline, 3 months and 12 months |
| Change in the PSQI questionnaire score | Self-administered questionnaire: Pittsburgh Sleep Quality Index (PSQI). The questionnaire will be used in adults and parents. It contains 19 items which are grouped into 7 components that contribute to the overall score. Each component is scored from 0 to 3, where 0 indicates no difficulty and 3 indicates severe difficulty. The 7 component scores are summed to produce a total score ranging from 0 to 21. | Baseline, 3 months and 12 months |
| Perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia, and sleep quality | Participant reported perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia and sleep quality measured with a question " Patient Global Impression of Change " (PGIC) (one for each dimension). Each PGIC will be used in adults, parents and children aged 11 years and above and consisting of one question with 7 modalities from 'Much worse" to "Much better". | Baseline, at 3 months and 12 months |
| Safety / Adverse events related to the use of the System | Number of diabetic ketoacidosis events, severe hypoglycemia requiring assistance (medical and non-medical), unplanned hospitalizations related to diabetes and other complications related to the use of the system that meet the predefined acceptance criteria based on safety parameters for the target devices. | 3 months and 12 months |
| Recruiting |
| Angers |
| 49933 |
| France |
| CH Victor Dupouy | Recruiting | Argenteuil | 95107 | France |
| Hôpital Bois Guillaume | Recruiting | Bois-Guillaume | 76230 | France |
| CHU de Bordeaux | Recruiting | Bordeaux | 33000 | France |
| CHU Brest - Hôpital La Cavale Blanche | Recruiting | Brest | 29609 | France |
| Hôpital Femme Mère Enfant Lyon | Recruiting | Bron | 69677 | France |
| CHU Grenoble Alpes | Recruiting | Grenoble | 38042 | France |
| Groupe Hospitalier de la Rochelle Ré Aunis | Recruiting | La Rochelle | 17019 | France |
| Hospices Civils de Lyon DIAB-Ecare | Recruiting | Lyon | 69008 | France |
| Hôpital Européen | Recruiting | Marseille | 13003 | France |
| Hôpital Europeen Georges Pompidou | Recruiting | Paris | 75015 | France |
| Hôpital Universitaire Necker Enfants Malades | Recruiting | Paris | 75015 | France |
| Groupe hospitalier Bichat Claude Bernard | Recruiting | Paris | 75018 | France |
| CH Périgueux | Recruiting | Périgueux | 24000 | France |
| CHU Poitiers | Recruiting | Poitiers | 86021 | France |
| Hôpital NOVO, Site Pontoise | Recruiting | Pontoise | 95300 | France |
| CHU Toulouse | Recruiting | Toulouse | 31059 | France |
| Clinique Pasteur | Recruiting | Toulouse | 31300 | France |
| CHRU Nancy-Hôpitaux de Brabois Adultes | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
| CH Bretagne Atlantique | Recruiting | Vannes | 56017 | France |
| Hôpital Robert Schuman-UNEOS | Recruiting | Vantoux | 57070 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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