Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Accuracy of estimate 1
研究概览
简要总结
The concept consists of an initial period (two weeks) of intensive data capture by use of continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second period (variable duration) of basal insulin titration guided by self monitored blood glucose. Data captured during the first period are used as input to an algorithm that estimates the optimal daily dose for the individual patient. The estimated optimal daily dose is used to guide the titration of the basal insulin during the second period. The goal is to safely and successfully achieve blood glucose targets. The concept is based on the use of basal insulin degludec (Tresiba, Novo Nordisk A/S).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Age 18-75 years
- •HbA1c 53-86 mmol/mol (7.0-10.0%)
- •BMI 20-40 kg/m2
- •Insulin-naïve
- •Willingness to use CGM consistently during the study period and send/receive data and dose advice to/from HCP via a mobile phone
- •Signed informed consent prior to any study procedures
排除标准
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •Active proliferative retinopathy
- •Mean blood glucose > 15 mmol/l the week prior to screening
- •Blood glucose > 20 mmol/l on the screening day
- •Non-fasting ketones > 0,5 mmol/l on the screening day
- •Use of sulfonylurea within 14 days prior to or during the study period
- •Change in other antidiabetic medicine than basal insulin during the study period
- •Use of corticosteroids within 30 days prior to or during the study period
- •Marked change in lifestyle within 30 days prior to or during the study period as assessed by the investigator
- •People with type 2 diabetes that suffer from conditions which make tight diabetes control undesirable, e.g. severe cardiovascular disease, according to the investigator
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- •Overall treatment
研究组 & 干预措施
The Starter Kit Algorithm
Basal insulin initiation and titration using the Starter Kit Algorithm at two weeks, followed by standard of care titration during the following the next 10 weeks (maximum), or until optimal daily dose is considered identified.
干预措施: Starter Kit Algorithm (Device)
结局指标
主要结局
Accuracy of estimate 1
时间窗: through study completion, 12 weeks
Accuracy of the estimated optimal daily dose (calculated by the Starter Kit algorithm based on continuous glucose monitoring (CGM) data collected during day 1-14) compared with the observed optimal daily dose in percentage deviation. In this context, optimal daily dose is the dose considered to keep fasting glucose levels below 6 mmol/L.
Accuracy of estimate 2
时间窗: through study completion, 12 weeks
The number of estimated optimal daily doses by the Starter Kit Algorithm at two weeks that fall within a patient specific confidence interval. The confidence interval is determined using the Starter Kit Algorithm at the end of study, one interval for each patient. Upper boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 4.0 mmol/L Lower boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 6.0 mmol/L
次要结局
- Accuracy of estimate 3(through study completion, 12 weeks)
- Time spent in hyperglycemia(8 days (first four and last four days of study))
- Number of patients in glucose target(through study completion, 12 weeks)
- Quality of treatment 2(through study completion, 12 weeks)
- Number of self-monitored blood glucose values ≤3.0 mmol/L(12 weeks (total duration of study))
- Severe hypoglycemia(12 weeks (total duration of study))
- Number of self-monitored blood glucose values ≤3.9 mmol/L(12 weeks (total duration of study))
- Time spent in hypoglycemia(8 days (first four and last four days of study))
- Time spent in normoglycemia(8 days (first four and last four days of study))
- Algorithm deviations(12 weeks (total duration of study))
- Quality of treatment 1(through study completion, 12 weeks)
研究者
Signe Schmidt
Principal Investigator
Hvidovre University Hospital