Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percentage of readings below 54 mg/dl
研究概览
简要总结
A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM).
The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented T1D for at least 1 year prior to study enrolment
- •Subjects aged 18 - 65 years old
- •A1c at inclusion ≤ 10%
- •Subjects using basal-bolus MDI therapy:
- •Basal insulin: Glargine, Degludec, or Determir
- •Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
- •Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
- •BMI < 28 kg/m2
- •Subjects willing to follow study instructions:
- •For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
- •For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities.
- •Subjects have connection to the internet at home.
- •Subjects have a smartphone compatible with study requirements
- •Subjects willing and able to sign a written informed consent form.
排除标准
- •An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
- •Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety
- •Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
- •Subject has unstable or rapidly progressive renal disease or is receiving dialysis
- •Subject has active proliferative retinopathy
- •Active gastroparesis
- •Participation in any other interventional study
- •Female subject who is pregnant or planning to become pregnant within the planned study duration
- •Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
- •Drug or alcohol abuse.
结局指标
主要结局
Percentage of readings below 54 mg/dl
时间窗: 9 weeks
Compare percentage of readings below 54 mg/dl during 3 weeks run-in period to percentage of readings below 54 mg/dl during intervention period.
次要结局
- Percentage of readings within range of 70-180 mg/dl(9 weeks)
- Change in HbA1C post study treatment(9 weeks)