A PILOT STUDY COMPARING the EFFICACY of DOSING ULTRA RAPID INSULIN LISPRO in a MEDTRONIC 780G HYBRID CLOSED LOOP SYSTEM AT MEALTIME or POSTMEAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Time in Glucose Range (70-180 mg/dL)
研究概览
简要总结
This is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin (URLi) used in a MiniMed 780G system hybrid closed loop system. Subjects with type 1 diabetes mellitus (T1DM) already using a 780G hybrid closed loop system with URLi will be included. After signing a remote digital informed consent, a baseline record of the MiniMed 780G system will be downloaded from the Medtronic digital platform (Carelink system [1]) and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary [2]. During the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks. During the last week of the intervention period, subjects will be asked to fill out a 3-day online food diary [2]. At the end of the intervention period- a Carelink report [1] will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences.
- Primary Objective: To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring.
- Secondary Objective: To assess patient dosing preferences and the effect of premeal dosing vs. post-meal dosing on patient reported outcomes
Ref:
- carelink.medtronic.eu
- NutRatio.com.
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
盲法说明
Both the researchers and the participants are aware of the intervention being administered (premeal vs. post-meal dosing of Ultra Rapid Lispro Insulin). There is no blinding in the study, as participants will know when they are administering the insulin (whether at mealtime or post-meal), and the researchers will also have access to this information during data collection and analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18 years of age or older (inclusive).
- •Diagnosed with Type 1 Diabetes Mellitus (T1DM).
- •Already using the MiniMed 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi) for at least 2 months prior to study enrollment.
- •Able and willing to provide informed consent electronically.
- •Willing and able to comply with the scheduled visits and other study procedures, including remote monitoring and completing questionnaires.
排除标准
- •Participants with a medical history of untreated active proliferative retinopathy.
- •Note: Subjects with non-proliferative retinopathy may be included. Subjects with treated proliferative retinopathy may be included based on the investigator's clinical judgment.
- •Severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or interfere with the interpretation of study results, as judged by the investigator.
研究组 & 干预措施
Mealtime and Postmeal Dosing of Ultra Rapid Lispro Insulin (URLi)
This arm consists of participants with Type 1 Diabetes Mellitus (T1DM) who are using the Medtronic 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi). Participants will undergo two intervention phases: in one phase, URLi will be administered at mealtime (premeal dosing), and in the other phase, URLi will be administered immediately after meals (postmeal dosing). The dosage form is subcutaneous insulin infusion, and the insulin dose is based on individual carbohydrate counting. Each intervention phase will last for up to 4 weeks, with glycemic control and patient preferences assessed at the end of each phase.
干预措施: Ultra Rapid Lispro (URLi) (Drug)
Mealtime and Postmeal Dosing of Ultra Rapid Lispro Insulin (URLi)
This arm consists of participants with Type 1 Diabetes Mellitus (T1DM) who are using the Medtronic 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi). Participants will undergo two intervention phases: in one phase, URLi will be administered at mealtime (premeal dosing), and in the other phase, URLi will be administered immediately after meals (postmeal dosing). The dosage form is subcutaneous insulin infusion, and the insulin dose is based on individual carbohydrate counting. Each intervention phase will last for up to 4 weeks, with glycemic control and patient preferences assessed at the end of each phase.
干预措施: Insulin pump with continuous glucose monitoring (CGM) (Device)
结局指标
主要结局
Percentage of Time in Glucose Range (70-180 mg/dL)
时间窗: Baseline to 4 weeks post-intervention
The primary outcome measure is the percentage of time that blood glucose levels are within the target range of 70-180 mg/dL (Time in Range, TIR) as measured by continuous glucose monitoring (CGM). This will be compared between the mealtime dosing and postmeal dosing phases of Ultra Rapid Lispro Insulin (URLi) in patients using the MiniMed 780G hybrid closed-loop system. The outcome will be assessed from the data collected via the CareLink system throughout the intervention period.
次要结局
未报告次要终点