A Prospective, Randomized, Double-Blind, Crossover Comparison Evaluating Compatibility and Safety of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Patients With Type 1 Diabetes (PRONTO-Pump)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 5
- 主要终点
- Rate of Infusion Set Failures
研究概览
简要总结
The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months.
- •Using an insulin pump with 'rapid-acting insulin' for at least 6 months and using the same rapid-acting insulin for at least the past 30 days.
- •Have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months.
- •Have hemoglobin A1c values ≤8.5%, as determined by the central laboratory at screening.
- •Have a body mass index (BMI) of ≤35 kilograms per meter squared at screening.
- •Have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days.
排除标准
- •Have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
- •Have had more than 1 emergency treatment for poor glucose control (hyperglycemia or diabetic ketoacidosis) in the last 6 months.
- •Have significant insulin resistance defined as having received a total daily dose of insulin >1.2 units per kilogram (U/kg) at screening, as determined by the average total daily insulin dose over the 3 days prior to screening divided by weight in kilograms based on investigator review of the participant's pump history.
- •Have significant lipohypertrophy, lipoatrophy, or scars within the subcutaneous tissue in areas of infusion or have a history of abscess at an infusion site within the last 90 days prior to screening.
- •Are receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than rapid-acting analog insulin via CSII in the 90 days prior to screening. Occasional pen or syringe injection of insulin is allowed, for example, due to pump malfunction or unexplained hyperglycemia not responsive to pump correction bolus.
- •Taking certain diabetes medications that are not allowed for study participation.
- •Have major problems with heart, kidneys, liver, or have a blood disorder.
- •Have had or are now being treated for certain types of cancer that prevents study participation.
研究组 & 干预措施
LY900014
100 units per milliliter (U/mL) LY900014 administered by individualized, continuous, subcutaneous insulin infusion (CSII)
干预措施: LY900014 (Drug)
Insulin Lispro
100 U/mL insulin lispro (Humalog®) administered by individualized CSII
干预措施: Insulin lispro (Drug)
结局指标
主要结局
Rate of Infusion Set Failures
时间窗: 6 Weeks
Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure \[last dose date and time -first dose date and time -duration of pump or treatment interruption\] times 30.
次要结局
- Rate of Premature Infusion Set Changes(6 Weeks)
- Percentage of Participants With at Least 1 Event of Infusion Set Failure(6 Weeks)
- Ratio of Bolus/Total Insulin Dose(6 Weeks)
- Interstitial Glucose Reduction Rate From Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump(6 Weeks)
- Time Interval Until Infusion Set Change(6 Weeks)
- Number of Participants With Severe Hypoglycemic Events(6 Weeks)