NCT07087340已完成不适用
Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop - Genesis
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage of time with the system functioning in closed-loop mode
研究概览
简要总结
The study is investigating the early feasibility of a novel algorithm for a hybrid closed-loop (HCL) insulin delivery system in adult patients with Type 1 diabetes.
Participants will attend a study visit where the UBLoop system on a smartphone will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter. Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •T1D diagnosis for at least one year.
- •Aged between 18 and 65 years old (inclusive).
- •Currently using insulin for at least six months.
- •Currently using closed-loop insulin therapy for at least three months.
- •Willingness to suspend any personal CGM for the duration of the pilot study once the study CGM is in place.
- •Willingness not to start any new non-insulin glucose-lowering agent during the study (including metformin/biguanides, incretin agonists [GIP/GLP-1RAs or GLP-1RAs], pramlintide, DPP-4 inhibitors, sulfonylureas, Sodium-glucose cotransporter-2 inhibitors [SGLT2 inhibitors], and nutraceuticals).
- •Understanding and willingness to follow the protocol and signed informed consent.
排除标准
- •An HbA1C ≥10% .
- •History of diabetic ketoacidosis (DKA) in the past 12 months.
- •History of severe hypoglycaemic event (Level 3): defined as seizure or loss of consciousness in the past 12 months.
- •Current uncontrolled chronic diabetic microvascular complications (neuropathy, retinopathy, renal diabetes disease, and diabetic gastroparesis).
- •Body Mass Index (BMI) ≤18.5 or ≥ 35 kg m2
- •Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2
- •Pregnancy or intent to become pregnant during the study.
- •Currently breastfeeding or planning to breastfeed.
- •Currently uncontrolled seizure disorder.
- •Planned surgery during the study duration.
- •Have uncontrolled hypertension (systolic BP above or equal to 160 mmHg and/or diastolic BP above or equal to 100 mmHg). If a participant is on anti-hypertensive therapies, doses must be stable for 30 days before screening. For participants with uncontrolled hypertension at the screening visit, antihypertensive medication may be started or adjusted.*
- •Personal history of one of the following cardiovascular conditions: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) in the last three months before the screening.
- •Conditions that may increase the risk of induced hypoglycemia such as known coronary artery disease, CHF (Have NYHA Functional Classification III or IV CHF), history of any cardiac disorder or arrhythmia, history of cerebrovascular event, hypoglycemia-induced migraine within the past six months, seizure disorder, syncope, adrenal insufficiency, or neurological disease).
- •Cystic fibrosis.
- •Uncontrolled thyroid disease as judged by the investigator.
- •Have an uncontrolled psychiatric condition such as (major depressive disorder, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder, alcohol or drug abuse).
- •Treatment with a non-insulin glucose-lowering agent, except metformin, in stable doses in the last three months.
- •Participants receiving or have received systemic glucocorticoid therapy within three months before screening (Prednisolone 10mg daily or equivalent >2 weeks) or chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations).
- •Have current treatment with (or history of, within 3 months before screening) medications that may affect glucose metabolism, as judged by the investigator.
- •Current enrolment in another clinical trial, unless approved by the investigator of both studies, and if the clinical trial is a non-interventional registry trial.
- •Have evidence of a significant active, uncontrolled medical condition or a history of any medical problem capable of constituting a risk when using the study devices or interfering with the interpretation of data, as judged by the study physician at screening.
研究组 & 干预措施
UBLoop Intervention Group
Experimental
For a period of approximately 10 hours, study participants will wear an insulin pump and a continuous glucose monitor (CGM), with the UBLoop system controlling insulin delivery based on the CGM readings. The UBLoop system will be operating via an app installed on a smartphone.
干预措施: UBLoop System (Device)
结局指标
主要结局
Percentage of time with the system functioning in closed-loop mode
时间窗: 10 hours
Failure rate of the HCL algorithm
时间窗: 10 hours
Failure rate of the communication with CGM device
时间窗: 10 hours
Failure rate of the communication with Insulin pump
时间窗: 10 hours
Failure rate of the user interface (BernSHELL)
时间窗: 10 hours
Failure rate of the web monitoring tool (DigiCARE)
时间窗: 10 hours
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
早期 1 期
HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALLHigh Risk Acute Lymphoblastic LeukemiaNCT05006040University of Colorado, Denver1
撤回
不适用
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 DiabetesType 1 DiabetesNCT02692547Medtronic Diabetes
已完成
不适用
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at HomeType 1 DiabetesNCT02748018Medtronic Diabetes959
已完成
不适用
An 8-Day Initiation of Advanced Hybrid Closed Loop System In Children and AdolescentsType 1 DiabetesNCT04509362Sidra Medicine34
进行中（未招募）
不适用
The Use of an Advanced Hybrid Closed Loop System in the Management of Individuals with Type 1 Diabetes and Sub-optimal Glycaemic Control Aged 12-25Type 1 DiabetesACTRN12619001452189Telethon Kids Institute46