Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Percent Time Spent 70-180 mg/dL
研究概览
简要总结
Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data.
Study Design: randomized controlled trial, with randomization on a night level within subject.
Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness in last 6 months; Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night.
Sample Size: 30 subjects.
Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use.
Major Efficacy Outcomes:
- Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
- Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.
Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis.
详细描述
Subjects who are eligible for the clinical trial initially will use a Veo insulin pump and Enlite 2 CGM sensor at home for a minimum of 6 days/week over a 2-week period to verify that the subject is able to use the CGM and insert sensors.
The first 10 subjects enrolled will participate in a 2-day overnight hotel-based pilot, collecting a total of 20 nights of data and experience with the system in a transitional hotel setting. The DSMB will review safety data from the 20 night hotel-based pilot study and make recommendations regarding proceeding to the at-home portion of the study.
Following DSMB review and approval of the safety data from the hotel study, the first 10 subjects will participate in an Algorithm Assessment Phase of approximately 10 nights of Predictive Low Glucose Suspend (PLGS) + Hyper Minimization system use each (for a nominal total of 100 nights of use at home) to determine if any adjustments to the algorithm parameters are needed and if it is safe to advance to the randomized clinical trial phase. If adjustments are needed, the Algorithm Assessment Phase will be repeated, using the same 10 subjects if possible. Once the randomized clinical trial phase begins, approximately 200 nights of randomized system use will be collected and assessed for safety by the DSMB before proceeding.
New subjects who enroll in the study after the completion of the Algorithm Assessment Phase will use the PLGS+Hyper Minimization closed-loop system at home for at least 5 days to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Subjects who successfully demonstrate their ability to use the system at home as described above will be eligible for the randomized trial phase. This phase consists of use of the full system in the home for approximately 42 nights:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Night-level randomization occurs automatically by computer software with no explicit indication of current night's assignment. Participant or study staff may become unmasked by scrutinizing insulin delivery details during a given night.
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •Age 15.0 to <46.0 years
- •HbA1c <10.0%
- •Measured with DCA2000 or equivalent device for assessing eligibility
- •HbA1c measurements performed as part of usual clinical care within 2 weeks prior to obtaining informed consent for participation in the trial may be used.
- •Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning
- •Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night
- •An understanding of and willingness to follow the protocol and sign the informed consent
排除标准
- •Diabetic ketoacidosis in the past 3 months
- •Hypoglycemic seizure or loss of consciousness in the past 6 months
- •History of seizure disorder (except for hypoglycemic seizure)
- •History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- •Cystic fibrosis
- •Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- •History of ongoing renal disease (other than microalbuminuria). Creatinine level must have been obtained within the last year if subject has diabetes of >10 years duration. If creatinine is >1.5 mg/dL (132 µmol/L), the subject is excluded.
- •Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- •Inpatient psychiatric treatment in the past 6 months
- •Uncontrolled adrenal disorder
- •Abuse of alcohol
- •Pregnancy Negative urine pregnancy test required for females who have experienced menarche as well as agreement from subject and parent/guardian to use a form of contraception to prevent pregnancy while participant is in the study. Subjects who become pregnant will be discontinued from the study.
- •Liver disease as defined by an ALT greater than 3 times the upper limit of normal
研究组 & 干预措施
Predictive Low Glucose Suspend (PLGS)
A predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or <230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
干预措施: Predictive Hypoglycemia Minimization Algorithm (Device)
Predictive Hyper/Hypo Minimizer (PHHM)
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or <230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
干预措施: Predictive Hyperglycemia Minimization Algorithm (Device)
Predictive Hyper/Hypo Minimizer (PHHM)
A predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or <230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
干预措施: Predictive Hypoglycemia Minimization Algorithm (Device)
结局指标
主要结局
Percent Time Spent 70-180 mg/dL
时间窗: Up to 42 nights
Mean percent of time participant spent with glucose values 70-180 mg/dl, measured by continuous glucose monitor of each night
次要结局
- Mean Sensor Glucose(Up to 42 nights)
- Percent Time Spent <50 mg/dL (2.8 mmol/L)(Up to 42 nights)
- Percent of Time Spent <60 mg/dL (3.3 mmol/L)(Up to 42 nights)
- Percent Time Spent <70 mg/dL (3.9 mmol/L)(Up to 42 nights)
- Percent Time Spent >180 mg/dL (10.0 mmol/L)(Up to 42 nights)
- Percent Time Spent >250 mg/dL (13.9 mmol/L)(42 nights)
- Percent Time Spent >300 mg/dL (16.7 mmol/L)(Up to 42 nights)
- Percent Time Spent >30 Min and >60 Min Consecutive <50 mg/dL (2.8 mmol/L)(Up to 42 nights)
- Percent Time Spent >30 Min and >60 Min Consecutively <60 mg/dL (3.3 mmol/L)(Up to 42 nights)
- Percent Time Spent With >30 Min and >60 Min Consecutively <70 mg/dL (3.9 mmol/L)(Up to 42 nights)
- Glucose Coefficient of Variation (CV)(Up to 42 nights)
- Amount of Total Insulin Boluses(Up to 42 nights)
- Mean Home Glucose Meter Morning Glucose(Up to 42 nights)
- Percent of Mornings With Glucose >250 mg/dL (13.9 mmol/L)(Up to 42 nights)
- Percent Time Spent 70 to 180 mg/dL (3.9 to 10.0 mmol/L) Overnight(Up to 42 nights)