Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 回顾性
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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
研究组 & 干预措施
Patients receiving routine care under a cooperation protocol for prandial insulin adjustment
干预措施: Routine care data collection (Other)
结局指标
主要结局
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
时间窗: Baseline and 6 months
次要结局
- Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0(Baseline, 3 months and 6 months)
- 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(Baseline and 3 months)
- Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0(Baseline, 3 months and 6 months)
- Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0(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(Baseline, 3 months and 6 months)
- Difference in glucose variability coefficient between M3 and M0 and between M6 and M0(Baseline, 3 months and 6 months)
- Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0(Baseline, 3 months and 6 months)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07846852
- 其他研究编号
- APHP260780
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared