Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes (INSUDIETCOOP)
This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Glycemic outcomes will be assessed using continuous glucose monitoring data collected during routine clinical care. The primary endpoint is the change in Time in Range (TIR) between baseline and 6 months.
調査の概要
詳細な説明
Type 1 diabetes requires continuous adjustment of insulin doses according to carbohydrate intake. In France, an interprofessional cooperation protocol implemented in 2023 authorizes trained dietitians to adjust insulin-to-carbohydrate ratios under physician supervision.
This retrospective multicenter cohort study will evaluate whether this organization improves glycemic control in routine clinical practice. Data will be collected from medical records and glucose monitoring platforms without modifying patient management.
The primary outcome is the difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6). Secondary outcomes include differences in hypoglycemia, hyperglycemia, glucose variability and Glucose Management Indicator (GMI) assessed between baseline and follow-up visits at Month 3 and Month 6.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Youcef Sekour
- 電話番号：+33156095823
- メール：youcef.sekour@aphp.fr
研究場所
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-
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Paris、フランス
- Service de diabétologie, Hôpital Lariboisière - AP-HP
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コンタクト：
- Hélène Louvet
- 電話番号：+33149959014
- メール：hélène.louvet@aphp.fr
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主任研究者：
- Hélène Louvet
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Paris、フランス
- Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
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コンタクト：
- Virginie Lafaille
- 電話番号：+33156095161
- メール：virginie.lafaille@aphp.fr
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主任研究者：
- Virginie Lafaille
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults aged 18-69 years with type 1 diabetes or insulin-deficient diabetes receiving routine care under an interprofessional cooperation protocol for prandial insulin dose adjustment. Eligible participants must have had diabetes for more than 6 months, be treated with multiple daily insulin injections or an insulin pump, and have completed structured education in functional insulin therapy. Patients with unstable proliferative retinopathy, pregnancy, other types of diabetes, temporary treatments affecting insulin requirements, legal protection measures, or who object to the use of their data are excluded
説明
Inclusion Criteria:
- Male or female, aged 18 to 69 years.
- Receiving routine clinical care under an interprofessional cooperation protocol for prandial insulin dose adjustment (protocol implemented since January 1, 2023).
- Living with type 1 diabetes mellitus or insulin-deficient diabetes, confirmed by the presence of anti-GAD, anti-IA2, anti-ZnT8, or insulin autoantibodies, and requiring optimization of insulin therapy.
- Diabetes duration greater than 6 months.
- Treated with multiple daily insulin injections or an insulin pump (open-loop or hybrid closed-loop system).
- Completion of a structured therapeutic education program in functional insulin therapy (individual consultations and/or educational workshops).
- Able to understand study information and procedures.
Exclusion Criteria:
- Unstable severe proliferative diabetic retinopathy.
- Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes.
- Pregnant women with type 1 diabetes.
- Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy).
- Individuals under legal guardianship, curatorship, or any other legal protection measure.
- Objection to the use of personal data for research purposes
研究計画
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：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Patients receiving routine care under a cooperation protocol for prandial insulin adjustment
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Data collection from patients receiving standard care under a cooperation protocol for prandial insulin dose adjustment, with data collected from patients' medical records and glucose monitoring platforms without modifying patient management |
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 |
|---|---|
|
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
時間枠：Baseline and 6 months
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Baseline and 6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Difference in time spent in the glycemic target range (Time in Range, TIR between 0.70 g/L and 1.80 g/L) between M3 and M0
時間枠：Baseline and 3 months
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Baseline and 3 months
|
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Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0
時間枠：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0
時間枠：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0
時間枠：Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
|
Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0
時間枠：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
|
|
Difference in glucose variability coefficient between M3 and M0 and between M6 and M0
時間枠：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
|
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Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0
時間枠：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Virginie Lafaille、Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- APHP260780
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?
IPD プランの説明
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD 共有時間枠
Two years after the last publication
IPD 共有アクセス基準
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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
米国FDA規制機器製品の研究
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