NCT05422053已完成不适用
Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Number of Diabetic Ketoacidosis Events
研究概览
简要总结
A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr.
详细描述
The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr. Up to 60 participants may be recruited.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of type 1 diabetes for at least 1 year
- •Currently using an insulin pump (of any brand) for at least 3 months, and will plan to use at least one basal rate above 3 units/hr with the study pump
- •HbA1c < 10.5%
- •Weight ≤ 200 kg
- •Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
- •Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF); and has agreed to follow all study procedures, including suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
- •Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin with the study pump.
- •Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
- •Willing and able to perform the study exercise and meal challenges.
- •Have a care partner, trained in hypoglycemia and hyperglycemia treatment guidelines, present during the challenges and until the next day.
- •Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.
排除标准
- •More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
- •More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
- •Inpatient psychiatric treatment in the past 6 months
- •History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
- •For Female: Currently pregnant or planning to become pregnant during the time period of study participation
- •Use of sulfonylureas, meglitinides or other medications specifically listed in protocol or determined by investigator to interfere with the study
- •Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or DPP-4 inhibitor as listed in the protocol, or starting a new non-insulin glucose lowering or weight loss agent during the trial
- •Hemophilia or any other bleeding disorder
- •History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
- •History of allergic reaction to Humalog or Novolog
- •Use of glucocorticoids or other medications determined by investigator to interfere with study
- •Abnormal screening electrocardiogram consistent with increased risk during study exercise activities, such as arrhythmia, ischemia, or prolonged QTc interval. Investigator will review all electrocardiograms
- •Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
- •History of adrenal insufficiency
- •History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
- •History of gastroparesis
- •A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- •Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
- •Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
结局指标
主要结局
Number of Diabetic Ketoacidosis Events
时间窗: 3 months
Number of diabetic ketoacidosis events during the entire study period
Unanticipated Adverse Device Effects
时间窗: 3 months
Number of unanticipated adverse device effects during the entire study period
Other Serious Adverse Events
时间窗: 3 months
Number of serious adverse events during the entire study period
Number of Severe Hypoglycemic Events
时间窗: 3 months
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period
次要结局
- CGM Time <54 mg/dL Daytime Only(3 months)
- CGM Time <70 mg/dL Overall(3 months)
- CGM Time <70 mg/dL Nighttime Only(3 months)
- CGM Time <54 mg/dL Nighttime Only(3 months)
- CGM Time <70 mg/dL Daytime Only(3 months)
- CGM Time <54 mg/dL Overall(3 months)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Closed-loop Insulin Delivery In Type 1 Diabetes Pregnancies (CIRCUIT)Type 1 Diabetes MellitusPregnancy RelatedGlucose Metabolism DisordersMetabolic DiseaseEndocrine System DiseasesNCT04902378University of Calgary94
已完成
不适用
Control-IQ Technology in Individuals With Type 2 DiabetesType 2 Diabetes Treated With InsulinNCT05111301Tandem Diabetes Care, Inc.30
已完成
不适用
A Pilot Test of t:Slim X2 With Control-IQ TechnologyType1 Diabetes MellitusNCT03368937University of Virginia5
已完成
不适用
OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump TherapyDiabetes Mellitus, Type 2NCT01182493Medtronic Diabetes331
已完成
不适用
Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski CampType 1 Diabetes MellitusNCT03369067University of Virginia48