Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Peak Post-prandial Venous Glucose Levels
研究概览
简要总结
"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.
详细描述
Open-label, crossover study comparing the peak post-prandial glucose levels and the incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control alone and during CL control with liraglutide in an inpatient research setting. Data generated during outpatient baseline evaluation and liraglutide dose titration phases of the study will be compared to assess the short-term efficacy of this agent during open-loop continuous subcutaneous insulin infusion (CSII) pump treatment.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-40 years
- •clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
- •duration of T1D ≥ 1 year
- •HbA1c ≤ 9 %
- •Treated with CSII for at least 3 months
- •Body weight > 50 kg (to accommodate phlebotomy)
- •Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct
排除标准
- •Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
- •Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- •Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- •History of hypoglycemic seizure within last 3 months
- •Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
- •Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
- •History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
- •Taking a medication known to affect gastric motility
- •History of pancreatitis, gallstones, alcoholism or high triglyceride levels
- •Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
- •Subjects unable to give consent
研究组 & 干预措施
Closed Loop Insulin Delivery
Each participant recruited into the study will undergo two inpatient closed loop admissions.
The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.
Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.
Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.
干预措施: ePID closed loop system (Device)
Closed Loop Insulin Delivery
Each participant recruited into the study will undergo two inpatient closed loop admissions.
The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.
Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.
Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.
干预措施: liraglutide (Drug)
结局指标
主要结局
Peak Post-prandial Venous Glucose Levels
时间窗: 48 hours
peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide
次要结局
- the Incremental Meal-related Glucose Area Under Curve (AUC)(5-hour post prandial period after breakfast, lunch, and dinner)
研究者
Jennifer Sherr
Instructor
Yale University