A Pilot Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Glucose outcomes: percentage of time spent in specific glucose ranges (ex: 3.9-10.0 mmol/L)
研究概览
简要总结
The objective of this study is to generate preliminary data in an inpatient setting to help optimize an insulin dosing logic (that decides how much to deliver insulin) for Eli Lilly's system.
详细描述
After being informed about the study and potential risks, all participants giving written informed consent will undergo an admission visit to determine eligibility for study entry. Participants who meet the inclusion and exclusion criteria will then participate in two 41-hour intervention visits using Eli Lilly's insulin dosing algorithm.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, all participants must meet the following criteria:
- •Adult male or female ≥ 18 years of age.
- •Type 2 diabetes mellitus has been clinically diagnosed (the diagnosis of type 2 diabetes is based on the investigator's judgment) for at least 12 months
- •Using multiple daily insulin injections (one basal and ≥ 2 prandial doses) for ≥ 3 months.
- •Using insulin glargine (U100 or U300), detemir, degludec, or NPH.
- •Most recent (in the last 6 month) HbA1c ≤ 10%.
- •Use of a GLP1 agonist or SGLT inhibitor for the past 3 months.
排除标准
- •Participants who meet any of the following criteria are not eligible for the study:
- •Severe hypoglycaemic episode ≤ two months before admission.
- •Ongoing pregnancy, or any newly diagnosed pregnancy throughout the study
- •Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- •Recent (within the past 6 months) acute macrovascular event (e.g. acute coronary syndrome or cardiac surgery).
- •Peripheral vascular disease, foot ulcer, Charcot arthropathy or any condition that limits ability to walk
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- •Use of oral hypoglycaemic agents besides SGLTi's, GLP1 agonists, and or metformin and unwilling to discontinue for the run-in and intervention period.
研究组 & 干预措施
Insulin alone closed-loop
干预措施: Insulin closed-loop (Other)
结局指标
主要结局
Glucose outcomes: percentage of time spent in specific glucose ranges (ex: 3.9-10.0 mmol/L)
时间窗: 24 hours
As this is a pilot study, the only primary outcome is the glucose outcomes during the closed-loop portion.
次要结局
未报告次要终点