A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor and Pump Therapy in the Management of Type 1 Diabetes Prone to Hypoglycemia
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Difference in percent of time spent with blood glucose level below 70 mg/dL
研究概览
简要总结
This study is a RCT of 3 month at home comparing closed-loop control (CLC) system vs sensor and pump therapy (S&P), with a 3-month extension phase, in Type 1 diabetic patient prone to hypoglycemia. After a 2-week run-in phase with blinded CGM, patients who spent 5% or more time below 70mg/dL will be eligible to continue. They will will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.
详细描述
This study is randomized controlled trial of 3 month at home closed-loop control (CLC) system vs sensor and pump therapy (S&P), with a 3-month extension phase. The objective is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system in patients with type 1 diabetes prone to hypoglycemia.
The CLC system will consist of Tandem Control-IQ Automated Insulin Delivery System (AIDS), including Tandem X2 insulin pump with embedded Control-IQ algorithm and Dexcom G6 CGM
After consent is signed, eligibility will be assessed. All participants will initiate a run-in phase of 2 weeks of blinded Dexcom G6 CGM wear and personal insulin pump.
Prior to overall initiation of the RCT, the time spent with CGM below 70 mg/dl during the run-in phase will be assessed. Only patients showing % time with CGM <70 mg/dl of 5% or above can be randomized. Included patients who cannot be randomized will be replaced.
Subsequent participants who show randomization criteria during the run-in phase will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S&P for 3 months, which is the timing of the primary outcome for the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
- •Use of an insulin pump for at least 6 months
- •Age ≥18 .0 years old
- •HbA1c level <10.5% at screening
- •Clarke score >3 and/or experience of severe hypoglycemia during the previous 6 months
- •For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- •Willingness not to use glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study. This does not concern treatment with Metformin active and stable for more than 3 months prior the inclusion. Moreover, the use of SGLT2 inhibitors is not allowed in the 3 months prior to enrollment.
- •Willingness to suspend use of any personal CGM for the duration of the clinical trial
- •Willingness to establish network connectivity on at least a weekly basis
- •Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog). Patients using glulisine (Apidra) may switch to lispro or aspart at least one month prior to enrollment.
- •Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- •Subject is covered by social health or similar insurance
- •Informed consent form signed
排除标准
- •Use of SGLT2 inhibitors in the 3 months prior to enrollment
- •Hemophilia or any other bleeding disorder
- •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 during the study
- •Employed by, or having immediate family members employed by Tandem or Dexcom
- •Persons deprived of freedom, protected by law or vulnerable persons
- •Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
- •Impaired renal function (Creatinine Clearance < 30 ml/min)
- •Patient who had pancreas transplantation or pancreatic islet transplantation
- •Patient having severe problems of uncorrected hearing and/or visual acuity
- •Subjects with known allergy to CGM adhesives
- •Patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment
- •Patient without any social or familial support able to intervene in case of severe hypoglycemic episode
研究组 & 干预措施
Closed-Loop Control (CLC)
Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm
干预措施: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions (Device)
Sensor Augmented Pump (SAP)
Closed-loop subcutaneous insulin infusion and continuous glucose monitoring manage by patient
干预措施: Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring (Device)
结局指标
主要结局
Difference in percent of time spent with blood glucose level below 70 mg/dL
时间窗: 3 months
Baseline-treatment difference in % of time spent with blood glucose level below 70 mg/dL over the 3 months follow-up
次要结局
- Insulin(3 months)
- Weight and Body Mass Index (BMI)(3 months)
- System Usability Scale (SUS)(3 months)
- Percent of time within target range 70-180 mg/dL(3 months)
- Percent of time spent with blood glucose level above 180 mg/dL(3 months)
- Mean blood glucose level(3 months)
- Percent of time spent with blood glucose level below 54 mg/dL(3 months)
- Percent of time spent with blood glucose in range 70-140 mg/dL(3 months)
- Glucose variability measured with the coefficient of variation (CV)(3 months)
- Glucose variability measured with the standard deviation (SD)(3 months)
- Percent of time spent with blood glucose level below 60 mg/dL(3 months)
- Low blood glucose index (LBGI)(3 months)
- Hypoglycemia events (defined as at least 15 consecutive minutes <70 mg/dL)(3 months)
- Percent of time spent with blood glucose level above 250 mg/dL(3 months)
- Percent of time spent with blood glucose level above 300 mg/dL(3 months)
- High blood glucose index (HBGI)(3 months)
- HbA1c at 3 months(at 3 months)
- HbA1c change from baseline to 3 months(3 months)
- Fear of Hypoglycemia Survey(3 months)
- Hyperglycemia Avoidance Scale(3 months)
- Diabetes Distress Scale(3 months)
- Hypoglycemia Confidence Scale(3 months)
- Clarke Hypoglycemia Awareness(3 months)
- INSPIRE survey(3 months)