Glycemic Control and Quality of Life Evolution for Patients With T1D Using the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 / 3 Plus Sensors in France
2026年9月28日 更新者：mylife Diabetes Care AG
Evolution in Glycemic Control and Quality of Life in Patients With Type 1 Diabetes Using the myLoop System With FreeStyle Libre 3 / 3 Plus Sensors in a Real-World Setting in France
The goal of this observational study is to learn how glucose control changes over one year in people with type 1 diabetes who use the myLoop with CamAPS FX and Freestyle Libre 3 or FreeStyle Libre 3 Plus during usual care in France. The main question it aims to answer is:
• How time in range (TIR) changes after one year of use. Time in range is the percentage of time glucose levels stay within the target range.
As secondary aims, the study aims to answer how other glucose measures (other than TIR, for example Time Above / Below Range) change at six months and one year.
Participants who are prescribed the myLoop with CamAPS FX during usual care for Type 1 Diabetes will:
- agree to have their routine clinical data on diabetes management and related complications before and after starting therapy with myLoop with CamAPS FX used for this study.
- answer online survey questions about their quality of life, use of the device and features and treatment satisfaction at six months and one year.
調査の概要
研究の種類
観察的
入学 (推定)
220
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
2年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
The study population will be recruited in France from 20 public or private hospitals and clinics which are qualified as insulin pump initiating centers according to national health reimbursement criteria.
説明
Inclusion Criteria:
- Patient has Type 1 Diabetes.
- Patient is 2 years or older if using FreeStyle Libre 3 Plus.
- Patient is 4 years or older if using FreeStyle Libre 3.
- Patient and their diabetes doctor have decided that the patient will use the myLoop with CamAPS FX and the FreeStyle Libre 3 or FreeStyle Libre 3 Plus as part of their diabetes treatment.
- The patient, or their parent/legal guardian if they are under 18, has a smartphone that works with CamAPS FX.
- The patient, or their parent/legal guardian if they are under 18, has a working email address and mobile phone number.
For adult patients:
- The patient has received the study information and has signed a consent form agreeing to take part in the study and to the use of their personal data for the study.
- Patient can read and understand French.
- Patient agrees to complete the online questionnaires and is able to use a smartphone.
For patients under 18 years of age:
- The patient's parent(s) or legal guardian(s) signed a consent form agreeing for the patient to take part in the study and for the patient's personal data to be used for the study. At least one parent or legal guardian must provide consent, as applicable. The patient will also be asked, appropriate for their age and understanding, to agree to take part in the study.
- Patient and/or their parent or legal guardian, as applicable, can read and understand French.
- Patient is old enough to complete the questionnaires, or their parent or legal guardian agrees to complete the online questionnaires; the person completing the questionnaires is able to use a smartphone.
Exclusion Criteria:
- Patient is currently using, or has used in the past 6 months, any hybrid closed-loop, fully closed-loop, or homemade ("do-it-yourself") closed-loop system.
- Patient is under a legal protection measure, such as guardianship or another form of court-ordered protection.
- Patient has a medical reason why the myLoop with CamAPAS FX and FreeStyle Libre 3/3 Plus system should not be used, including any reason listed in the most recent instructions for use of any of these medical devices.
- Patient has an unresolved skin condition where the sensor and/or pump tubing would be placed, such as psoriasis, dermatitis herpetiformis, a skin rash, or a staphylococcal (staph) infection.
- Patient is expected to not be able to continue follow-up at the study center for the next 12 months.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months
時間枠：Baseline and 6 months
|
Baseline and 6 months
|
|
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Mean glucose derived from CGM data (mg/dL)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Mean glucose derived from CGM data (mg/dL)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose standard deviation (SD) derived from CGM data (mg/dL)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose standard deviation (SD) derived from CGM data (mg/dL)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose coefficient of variation (CV) derived from CGM data
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose coefficient of variation (CV) derived from CGM data
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose Management Indicator (GMI) derived from CGM data
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose Management Indicator (GMI) derived from CGM data
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose Risk Index (GRI) derived from CGM data
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose Risk Index (GRI) derived from CGM data
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Change in HbA1c levels (%)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Change in HbA1c levels (%)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients <13: Quality of Life questionnaire (animated emoji scale)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients <13: Quality of Life questionnaire (animated emoji scale)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
時間枠：Baseline and 6 Months
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Baseline and 6 Months
|
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Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
時間枠：Baseline and 12 Months
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Baseline and 12 Months
|
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Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
時間枠：Baseline and 6 Months
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Baseline and 6 Months
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Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
時間枠：Baseline and 12 Months
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Baseline and 12 Months
|
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Patients aged ≥ 18 years: INSPIRE questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged ≥ 18 years: INSPIRE questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients aged 13-17 years: INSPIRE Youth questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients aged 13-17 years: INSPIRE Youth questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
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Patients < 13 years: INSPIRE Parent questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
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Patients < 13 years: INSPIRE Parent questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
時間枠：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
時間枠：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)
時間枠：at 12 Months
|
at 12 Months
|
|
Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode
時間枠：at 12 Months
|
at 12 Months
|
|
Percentage of time in hybrid closed-loop (%)
時間枠：at 6 Months
|
at 6 Months
|
|
Percentage of time in hybrid closed-loop (%)
時間枠：at 12 Months
|
at 12 Months
|
|
Percentage of time using different system features (%)
時間枠：at 6 Months
|
at 6 Months
|
|
Percentage of time using different system features (%)
時間枠：at 12 Months
|
at 12 Months
|
|
Number of Safety / Adverse Events: Severe Hypoglycemia
時間枠：At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Severe Hypoglycemia
時間枠：At 12 Months
|
At 12 Months
|
|
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
時間枠：At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
時間枠：At 12 Months
|
At 12 Months
|
|
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
時間枠：At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
時間枠：At 12 Months
|
At 12 Months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年4月1日
研究の完了 (推定)
2028年4月1日
試験登録日
最初に提出
2026年9月17日
QC基準を満たした最初の提出物
2026年9月17日
最初の投稿 (実際)
2026年9月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年10月1日
QC基準を満たした最後の更新が送信されました
2026年9月28日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CIV-FR-26-08-059499
- 2026-A01226-45 (その他の識別子：ANSM France)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。