A New Wizard for Insulin Sensitivity Estimation From SAP: a Randomized Controlled Trial in Adolescents With T1D
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- overall time in target (70-180mg/dl)
研究概览
简要总结
We aim to test the efficacy of a new method for determining individual insulin sensitivity (IS) based on sensor-augmented-insulin pump (SAP) data in order to customize the insulin to carbohydrate ratio (CR) in adolescents with type 1 diabetes (T1D).
To date, the individual insulin sensitivity (IS) could only be investigated by intensive and invasive research techniques that are not feasible to perform in an outpatient setting for pediatric patients with diabetes.
Recently published studies have demonstrated the efficacy of an algorithm to calculate the patient specific insulin sensitivity to customize the CR for adult patients with T1D. The algorithm has been validated in adult patients, however not yet investigated in the pediatric population with T1D.
The aims of our study are:
- to customize the CR of pediatric subjects with T1D using the individualized insulin sensitivity index (ISind) to improve post-prandial blood glucose control after a standard meal.
- to test, under free living condition (at home), the efficacy of the customized CR in improving post-prandial glycemic control for pediatric subjects with T1D.
This approach would have at least two potential benefits for pediatric patients with T1D:
- To provide a non-invasive tool for individualizing their home insulin therapy;
- To offer a reliable instrument for adjusting the meal bolus of the current hybrid closed loop (HCL) systems to account for the inter-subject variability in insulin action.
详细描述
A new method to assess insulin sensitivity (IS) has been proposed and investigated by the PI and his group at the University of Padova. The new insulin sensitivity index, named "SISP" is calculated from data derived from insulin pump and continuous glucose monitoring (CGM) uploads. The efficiency of the SISP has been tested in-silico using the University of Virginia/Padova T1D simulator by mimicking a single-meal scenario with patient-specific optimized carbohydrate ratio (CR) (increased or decreased by 20%) and optimal CR. In all the simulations the use of the optimal CR, calculated with the proposed method, has improved the overall glycemic control. The simulator (S2013) used for this purpose has been valdated and is approved by the FDA as a substitute for preclinical trials for insulin treatments, including closed-loop algorithms. It is comprised of data from 100 in-silico patients that represent the biological variability of a generic real diabetic population. Thus, an algorithm that is tuned on the basis of in-silico analysis can be safely implemented in real-life setting.
The method to estimate SISP and to optimize the CR from SAP data, could be easily applied to the daily management of patients with T1D and in a closed-loop context since several closed-loop algorithms, currently used in clinical trials, are based on the pre-programmed open-loop insulin therapy.
Once the individualized SISP is calculated, it can be used to customize the CR using the in-silico tested algorithm to determine an individualized CR (CRIND).
Consequently, the CRIND can be tested in outpatient setting safely, and adjusted in a run-to-run framework, using a well described approach of self-learning, the latter allowing titration of the insulin therapy based on CGM data using a self-learning algorithm as previously described.
- Phase 1: "Control period". This phase represents the control frame-time, during which patients, once enrolled, will use their SAP without any adjustment of the CR and correction factors, according to the parameters recorded at the screening visit. This phase is aimed to record the CGM data and will represent the control period of the study. It lasts 3 weeks.
- Phase 2: "Build-up period" This phase is aimed to obtain an adequate amount of data for customizing the insulin pump parameters to the specific features of each subject according to the proposed algorithms. It consists of three standardized meals (Figure 2) and a run-in phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-21 year old.
- •Clinical diagnosis of T1D ≥1 year
- •Treatment with sensor augmented pump therapy (insulin pump + glucose sensor) for at least 1 month
- •HbA1c <10%
- •Be able to comprehend written and spoken English
- •Exclusion Criteria
- •Pregnancy, breast feeding, or plans to get pregnant for the next 12 months
- •On medications that affect insulin sensitivity; has other medical conditions known to affect insulin sensitivity;
- •Cognitive impairment
排除标准
- 未提供
研究组 & 干预措施
All participants
+Pediatric patients with T1D. All comparisons will be made within group pre and post intervention.
干预措施: individualized insulin sensitivity index (ISind) (Other)
结局指标
主要结局
overall time in target (70-180mg/dl)
时间窗: 4 weeks
the percentage of time in target will be calculated "(time in target/total time of records using continuous glucose monitoring)\*100.
次要结局
- overall time in target (70-180mg/dl) after meal 1(180 minutes post meal)
- overall time in target (70-180mg/dl) after meal 2(180 minutes post meal)
- median percentage of time spent in hypoglycemia (<70mg/dl) during control period(4 weeks)
- median percentage of time spent in hypoglycemia (<70mg/dl) post meal 1(180 minutes post meal)
- median percentage of time spent in hypoglycemia (<70mg/dl) post meal 2(180 minutes post meal)
- median percentage of time spent in hypoglycemia (<70mg/dl) post meal 3(180 minutes post meal)
- median percentage of time spent in hypoglycemia (<70mg/dl) during Intervention phase(4 weeks)
- overall time in target (70-180mg/dl) after meal 3(180 minutes post meal)
- overall time in target (70-180mg/dl) during Intervention phase(4 weeks)
- median percentage of time in hyperglycemia (>180mg/dl) during Control Phase(4 weeks)
- median percentage of time in hyperglycemia (>180mg/dl) after meal 1(180 minutes post meal)
- median percentage of time in hyperglycemia (>180mg/dl) after meal 2(180 minutes post meal)
- median percentage of time in hyperglycemia (>180mg/dl)after meal 3(180 minutes post meal)
- median percentage of time in hyperglycemia (>180mg/dl) during intervention phase(4 weeks)
- median percentage of time below 50mg/dl during control phase(4 weeks)
- median percentage of time below 50mg/dl after meal 1(180 minutes post meal)
- median percentage of time below 50mg/dl after meal 2(180 minutes post meal)
- median percentage of time below 50mg/dl after meal 3(180 minutes post meal)
- median percentage of time below 50mg/dl during intervention phase(4 weeks)
- severe hypoglycemic events during control phase(4 weeks)
- severe hypoglycemic events after meal 1(up to 24 hours)
- severe hypoglycemic events after meal 2(up to 24 hours)
- severe hypoglycemic events after meal 3(up to 24 hours)
- severe hypoglycemic events during intervention phase(4 weeks)
- active hypoglycemia correction (carbohydrate intake) during control phase(4 weeks)
- active hypoglycemia correction (carbohydrate intake) after meal 1(up to 24 hours)
- active hypoglycemia correction (carbohydrate intake) after meal 2(up to 24 hours)
- active hypoglycemia correction (carbohydrate intake) after meal 3(up to 23 hours)
- active hypoglycemia correction (carbohydrate intake) during intervention phase(4 weeks)
- corrective bolus after meal during control phase(4 weeks)
- corrective bolus after meal 1(up to 24 hours)
- corrective bolus after meal after meal 2(up to 24 hours)
- corrective bolus after meal after meal 3(up to 24 hours)
- corrective bolus after meal during intervention phase(4 weeks)