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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Youcef Sekour
- 电话号码：+33156095823
- 邮箱：youcef.sekour@aphp.fr
学习地点
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-
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Paris、法国
- Service de diabétologie, Hôpital Lariboisière - AP-HP
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接触：
- Hélène Louvet
- 电话号码：+33149959014
- 邮箱：hélène.louvet@aphp.fr
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首席研究员：
- Hélène Louvet
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Paris、法国
- Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
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接触：
- Virginie Lafaille
- 电话号码：+33156095161
- 邮箱：virginie.lafaille@aphp.fr
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首席研究员：
- Virginie Lafaille
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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 |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
大体时间：Baseline and 6 months
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Baseline and 6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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
大体时间：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
大体时间：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
大体时间：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
大体时间：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 hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0
大体时间：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in glucose variability coefficient between M3 and M0 and between M6 and M0
大体时间：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
大体时间：Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Virginie Lafaille、Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- APHP260780
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
Two years after the last publication
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
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