Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Sensor glucose percentage of time in hypoglycemia below 54 mg/dl
研究概览
简要总结
The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM).
The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks.
The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
- •Aged ≥ 14 years
- •HbA1c of 6.5 ≤ A1c ≤ 10%
- •Using basal-bolus MDI therapy:
- •Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin
- •Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
- •Subjects willing to follow study instructions:
- •For SMBG users (only for segment 1): measure capillary blood glucose at least 4 times a day . Document blood glucose level, insulin delivery, meals and daily activities. Wear CGM.
- •For CGM users (FGM with a reader or real-time CGM): Use CGM according to manufacture instructions, document insulin delivery, meals and daily activities.
- •Subjects using CGM or SMBG that are compatible with data transmission to the study diabetes management system (i.e. for CGM, FGM with a reader).
- •Fasting glucose target is < = 180 mg/dl (T2D)
- •Subjects have home computer connected to the internet.
- •Subjects have a smart phone 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
- •Subject has loss of kidney function as measured by estimated Glomerular Filtration Rate (eGFR) <45 in the previous 3 months
- •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.
研究组 & 干预措施
Intervention
Subject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro Decision Support System-MDI algorithm. During the feasibility segment an approval of the study physician (may override the suggestions for safety reasons) will be required prior to sending the recomendations to participants. During the Proof of Concept segment, the recomendations will be sent directly to participants. Participants will be asked to follow the tretment plan for the following 2.5 weeks.
干预措施: DreaMed Advisor Pro DSS-MDI algorithm (Device)
结局指标
主要结局
Sensor glucose percentage of time in hypoglycemia below 54 mg/dl
时间窗: 12-16 weeks
Sensor glucose percentage of time in hyperglycemia above 250 mg/dl
时间窗: 12-16 weeks
次要结局
- Percentage of readings within range of 70-180 mg/dl(12-16 weeks)
- Change in HbA1C post study treatment(12-16 weeks)
- Number of Serious Adverse Events(12-16 weeks)