Evaluating the Benefits of Physiologic Insulin Delivery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Glucagon Response to Induced Hypoglycemia
研究概览
简要总结
In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.
详细描述
The eventual goal of this line of work is an implanted insulin pump that delivers insulin automatically into the peritoneum based on continuous glucose data. All prior intraperitoneal pharmacokinetic studies used only concentrated regular insulin, which may be too slow to provide full closed-loop insulin delivery without meal announcement. A description of intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors that may counter hypoglycemia is needed. Upper versus lower peritoneal delivery may also affect insulin kinetics. A possible benefit of intraperitoneal insulin is restoration of glucagon response in longstanding diabetes and clearance of insulin by the liver, both of which could provide hypoglycemic rescue in automated insulin delivery systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Clinical diagnosis of type 1 diabetes
- •On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months
- •Ability to safely receive intraperitoneal injection
- •For females, not currently known to be pregnant
- •Understanding and willingness to follow the protocol and sign informed consent
- •Ability to speak, read and write in the language of the investigators
排除标准
- •Diabetic ketoacidosis in the past 3 months
- •Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
- •Pregnant or lactating
- •Active infection
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- •Known cardiovascular events in the last 6 months
- •Known seizure disorder
- •Inpatient psychiatric treatment in the past 6 months
- •Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
- •Suspected drug or alcohol abuse
- •Chronic kidney disease (GFR < 60 mL/min/1.73m^2)
研究组 & 干预措施
Upper Peritoneal, then Lower Peritoneal, then Subcutaneous
Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.
干预措施: Ultra-rapid insulin (Drug)
Lower Peritoneal, then Upper Peritoneal, then Subcutaneous
Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.
干预措施: Ultra-rapid insulin (Drug)
结局指标
主要结局
Glucagon Response to Induced Hypoglycemia
时间窗: Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
For each injection site we will assess the peak concentration of glucagon at time of the first induced hypoglycemic nadir. Analysis includes reporting groups for each type of injection, and upper and lower peritoneal injections combined (Injection- All Peritoneal). Participants must have achieved induced hypoglycemia to be evaluable for the primary outcome.
次要结局
- Insulin Maximum Concentration in Plasma(Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max)
- Hypoglycemic Treatments Required as a Measure of Glucose Values(Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max)
- Time Until Maximum Insulin Concentration in Plasma(Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max)
研究者
Rayhan A. Lal
Med+Peds Endocrinologist
Stanford University