A Crossover Study to Evaluate Insulin/Pramlintide Versus Insulin Alone Delivery Strategy
概览
- 阶段
- 不适用
- 干预措施
- MPC closed-loop system in insulin only mode
- 疾病 / 适应症
- Type 1 Diabetes
- 发起方
- Oregon Health and Science University
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Incremental Area Under the Curve of Postprandial Glucose Following the First Meal
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.
详细描述
Participants will undergo two 12.5 hour clinic visits. Participants will complete a training on how to start the Dexcom G6 sensor at home. Participants will start the G6 sensor the day before each study visit. For one visit, the system will use insulin only for managing blood sugar. For the other study, the system will use both insulin and pramlintide. The order of the visits will be randomly chosen. For 3 days before the insulin and pramlintide visit, participants will dose with pramlintide before each meal. During the visits, participants will wear one or two Omnipods to delivery insulin and insulin/pramlintide and a Dexcom G6 CGM. The CGM system will provide sensor glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat breakfast and lunch in clinic.
研究者
Leah Wilson
Principal Investigator
Oregon Health and Science University
入排标准
入选标准
- •Diagnosis of type 1 diabetes mellitus for at least 1 year.
- •Participants 18 to 70 years of age.
- •Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks.
- •Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
- •HbA1c ≤ 10.5% at screening.
- •Total daily insulin requirement is less than 139 units/day.
- •Willingness to follow all study procedures, including attending all clinic visits.
- •Willingness to sign informed consent and HIPAA documents.
排除标准
- •Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- •Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- •Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
- •Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- •History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
- •History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
- •Adrenal insufficiency.
- •Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
- •Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- •Seizure disorder.
研究组 & 干预措施
Insulin Only Arm
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
干预措施: MPC closed-loop system in insulin only mode
Insulin and Pramlintide Arm
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
干预措施: MPC closed-loop system in insulin/pramlintide mode
结局指标
主要结局
Incremental Area Under the Curve of Postprandial Glucose Following the First Meal
时间窗: 6 hours following first meal
Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL\*min)/1000.
Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal
时间窗: 6 hours following first meal
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
次要结局
- Low Blood Glucose Index (LBGI)(12 hour clinic visit)
- High Blood Glucose Index (HBGI)(12 hour clinic visit)
- Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal(6 hours following second meal)
- Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal(6 hours following second meal)
- Net Area Under the Curve of Postprandial Glucose Following the First Meal(6 hours following first meal)
- Net Area Under the Curve of Postprandial Glucose Following the Second Meal(6 hours following second meal)
- Net Area Under the Curve of Postprandial Glucose(12 hour clinic visit)
- Percent of Time With Sensed Glucose <70 mg/dL Following First Meal(6 hours following first meal)
- Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal(6 hours following second meal)
- Percent of Time With Sensed Glucose <70 mg/dL(12 hour clinic visit)
- Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal(6 hours following first meal)
- Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal(6 hours following second meal)
- Percent of Time With Sensed Glucose Between 70-140 mg/dL(12 hour clinic visit)
- Mean Sensed Glucose Following First Meal(6 hours following first meal)
- Mean Sensed Glucose Following Second Meal(6 hours following second meal)
- Mean Sensed Glucose(12 hour clinic visit)
- Percent of Time With Sensed Glucose <54 mg/dL Following First Meal(6 hours following first meal)
- Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal(6 hours following second meal)
- Percent of Time With Sensed Glucose <54 mg/dL(12 hour clinic visit)
- Percent of Time With Sensed Glucose >180 mg/dL Following First Meal(6 hours following first meal)
- Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal(6 hours following second meal)
- Percent of Time With Sensed Glucose >180 mg/dL(12 hour clinic visit)
- Percent of Time With Sensed Glucose >250 mg/dL Following First Meal(6 hours following first meal)
- Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal(6 hours following second meal)
- Percent of Time With Sensed Glucose >250 mg/dL(12 hour clinic visit)
- Median Amount of Insulin Delivered Following First Meal(6 hours following the first meal)
- Median Amount of Insulin Delivered Following Second Meal(6 hours following the second meal)
- Median Amount of Insulin Delivered(12 hour clinic visit)
- Median Amount of Pramlintide Delivered Following First Meal(6 hours following the first meal)
- Median Amount of Pramlintide Delivered Following Second Meal(6 hours following the second meal)
- Median Amount of Pramlintide Delivered(12 hour clinic visit)
- Coefficient of Variation Following First Meal(6 hours following the first meal)
- Coefficient of Variation Following Second Meal(6 hours following the second meal)
- Coefficient of Variation(12 hour clinic visit)
- Low Blood Glucose Index (LBGI) Following the First Meal(6 hours following the first meal)
- Low Blood Glucose Index (LBGI) Following the Second Meal(6 hours following the second meal)
- High Blood Glucose Index (HBGI) Following the First Meal(6 hours following the first meal)
- High Blood Glucose Index (HBGI) Following the Second Meal(6 hours following the second meal)
- Adverse Events Related to Pramlintide(4 days of pramlintide use)
- Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal(6 hours following first meal)
- Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal(6 hours following second meal)
- Mean Duration of Gastrointestinal Issues After the First Meal(6 hours following first meal)
- Mean Duration of Gastrointestinal Issues After the Second Meal(6 hours following second meal)
- Episodes of Hypoglycemia(12 hour clinic visit)
- Episodes of Carbohydrate Intake to Treat Hypoglycemia(12 hour clinic visit)
- Number of Provider-administered Insulin Injections(12 hour clinic visit)