An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1-Hour Change in Postprandial Plasma Glucose (PPG)
研究概览
简要总结
This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.
详细描述
This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.
Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.
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
- 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
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, age ≥18 years at the time of signing informed consent
- •Documented diagnoses of T1DM ≥1 year prior to the day of screening
- •Using the Medtronic pump Minimed 670G for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least 30 days prior to screening and willing to continue using their personal Medtronic Minimed 670G and CSII for insulin treatment throughout the trial.
- •Ability and willingness to use the same insulin infusion sets throughout the trial
- •Using the same insulin for at least 30 days prior to screening
- •HbA1c < 8.5% as assessed by local laboratory at screening
- •BMI ≤ 35.0 kg/m2 at screening
- •Ability and willingness to adhere to the protocol including performing SMPG profiles, attending visits, utilizing the auto mode feature of the pump for at least 80 % of the time during the study, and completing meal tests
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
- •Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
- •Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening
- •Subjects classified as being in New York Heart Association (NYHA) Class IV at screening
- •Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
- •Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic
- •≥180 mmHg or diastolic ≥110 mmHg) at screening
- •Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 ml/min/1.73 m2
- •Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator
- •Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening
- •History of hospitalization for ketoacidosis ≤180 days prior to the day of screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening
- •Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
- •Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion
- •Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol
研究组 & 干预措施
Fiasp/Novolog
7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
干预措施: Fiasp® (Drug)
Novolog/Fiasp
7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
干预措施: 670G hybrid closed loop continuous subcutaneous insulin infusion system (Device)
Fiasp/Novolog
7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
干预措施: Novolog® (Drug)
Fiasp/Novolog
7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
干预措施: 670G hybrid closed loop continuous subcutaneous insulin infusion system (Device)
Novolog/Fiasp
7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
干预措施: Fiasp® (Drug)
Novolog/Fiasp
7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
干预措施: Novolog® (Drug)
结局指标
主要结局
1-Hour Change in Postprandial Plasma Glucose (PPG)
时间窗: 6th week of therapy
Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test
次要结局
- Percentage of Time Spent Between 70 mg/dL and 180 mg/dL(Weeks 1 through 6, Weeks 8 through 13)
- Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)(Weeks 1 through 6, Weeks 8 through 13)
- Insulin Pump - Active Insulin Time(Weeks 1 through 6, Weeks 8 through 13)
- 2-Hour Change in Postprandial Plasma Glucose (PPG)(6th week of therapy)
- Percentage of Time Spent Between Below 70 mg/dL(Weeks 1 through 6, Weeks 8 through 13)
- Percentage of Time Spent Above 200 mg/dL(Weeks 1 through 6, Weeks 8 through 13)
- Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)(Weeks 1 through 6, Weeks 8 through 13)
- 1,5 Anhydroglucitol Levels(Week 6, Week 13)
- Fructosamine Levels(Week 6, Week 13)
- HbA1c(Week 6, Week 13)
- Insulin Use - Change in Daily Dose(Weeks 1 through 6, Weeks 8 through 13)
- Insulin Use - Bolus(Weeks 1 through 6, Weeks 8 through 13)
- Insulin Use - Automatic Basal Insulin(Weeks 1 through 6, Weeks 8 through 13)
- Infusion Site Reactions(14 week treatment period)
- Pump Occlusions(14 week treatment period)
- Insulin Use - Basal(Weeks 1 through 6, Weeks 8 through 13)
- Insulin Pump - Auto Mode(Weeks 3 through 6, Weeks 10 through 13)
- Insulin Pump - Manual Mode(Weeks 3 through 6, Weeks 10 through 13)
- Change in Carbohydrate Ratio(Weeks 1 through 6, Weeks 8 through 13)
研究者
Thomas C. Blevins, M.D.
PI
Texas Diabetes & Endocrinology, P.A.