Evaluation Of Hybrid Closed Loop (HCL) System On-Boarding Protocol, For Patients With Type 1 Diabetes On Multiple Daily Insulin Injections (MDI) Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months.
研究概览
简要总结
The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop (HCL) systems in achieving glucose control of patients on Multiple Daily Insulin Injections (MDI).
详细描述
Goal
The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop systems in achieving glucose control of patients on MDI.
Methods
This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 40 subjects (age 18-65) will be enrolled in order to reach 34 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from Continuous Glucose Monitoring (CGM) will be performed at baseline and at the end of the 3-month study period. The following parameters will be analyzed" % patients achieving glucose readings Time in Range (TIR) > 67% in (70-180 mg/dl); % patients achieving <3% Time below Range ( <70 mg/dl) and % patients achieving both TIR > 67% and <3% Time below Range.Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •HbA1c < 12.5%
- •Age18-65 years at the initiation of the 670G system
- •Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period
- •Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- •Clinically planning to and be able to start the Medtronic 670G HCL system
- •History of 3 clinic visits in the last year
- •With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist.
排除标准
- •Diabetic Ketoacidosis in the 6 months prior to screening visit
- •Type 2 diabetes
- •Hyperthyroidism at time of screening
- •Using Pramlintide, Dipeptidyl peptidase 4 (DPP-4) inhibitor, Glucagon-like peptide-1 (GLP-1) agonists, metformin, sodium-glucose transport protein 2 (SGLT2) inhibitors at time of screening.
- •Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study.
结局指标
主要结局
The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months.
时间窗: 3 months
The achievable Time in Range (TIR) in the first 3 months of MiniMed 670G following onboarding of MDI to HCL by the protocol in a real-life setting.
次要结局
- percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl)(3 months)
- percentage of patients achieving both TIR > 67% and <3% Time below Range(3 months)
- Change in HBA1C from baseline(3 months)
- Number of severe hypoglycemia episodes(3 months)
- Total daily insulin dose(3 months)
- percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl)(3 months)
- Change in sensor glucose values from baseline(3 months)
- Percentage of time above Range (>180 mg/dl) for the whole study population(3 months)
- Number of Diabetic Ketoacidosis episodes(3 months)
- Percentage of time spend in Auto Mode(3 months)