Assessment of an Integrated Continuous Glucose Monitor and Insulin Injection Port in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- glucose sensing accuracy
研究概览
简要总结
THE GOALS of the STUDY are: (1) Determine if this novel continuous glucose monitoring (CGM) - multiple daily injection (MDI) port functions for 7 days in persons with Type 2 diabetes (T2D); (2) Measure the duration of glucose measurement errors that result from injecting liquid into the tissue. It is believed that these errors will be small and will not exceed 15-20 min in duration; (3) Determine how safe this device is; (4) In a survey given to subjects and other subjects after the study, to assess satisfaction and convenience vs standard MDI; (5) Assess accuracy of the glucose sensor; and (6) Compare how well subjects' glucose is controlled with the new device compared to the comparison (control) period in which subjects use standard MDI, during which the injections will be far away from the CGM.
详细描述
Study Goal: Carry out 7-day study in 18 subjects with T2D who use MDI. Compare use of the PDT CGM injection port with standard site-rotated MDI injections; test potential insulin incompatibility of long-and short-acting insulin.
Experimental Protocol: Approval will be obtained from OHSU IRB after the IDE is cleared by FDA. Subjects with T2D (n=18 in total) using MDI will be recruited from Dr. Castle's OHSU Diabetes Clinic.
Informed consent and insulin regimen: Informed consent and signing will precede a screening visit which will include history, physical exam, complete blood count, electrolytes, BUN, creatinine, liver panel, calcium and phosphorus. Those who pass will be pseudo-randomized to injecting insulin through the sensing port during days 2-4 and crossing over to standard subcutaneous injections during days 5-7 or vice-versa. Prior to starting insulin pen usage, a visit will be scheduled with a diabetes research staff member or a certified diabetes educator to demonstrate the proper pen usage and port mating. Before the study begins, Dr. Castle will modify the MDI regimen to include aspart or rapid aspart insulin (Fiasp) before meals and long-acting (degludec) at bedtime. Dr. Henrik Bengsston from Novo has clarified that degludec insulin (neutral pH) is compatible with Novo fast-acting preparations.
Study Goals: (1) Demonstrate that CGM accuracy over 7d during injections via the CGM-MDI port is not inferior to accuracy during remote SC injections; (2) Demonstrate that algorithmic compensation for the dilution artifact will maintain sensor accuracy in the hour after boluses; (3) Validate the safety of the novel CGM-MDI port; (4) assess port longevity, and (5) assess subject satisfaction with port usage.
In addition, there is a possibility that degludec insulin remaining in the SC depot will alter the pharmacodynamics of the aspart given the next day. The study design will allow investigators to address this possibility by evaluating post-prandial glycemic control on Day 7 after the first meal: in 50% of cases, the prior degludec will have been given via the port into the same SC depot; in the other 50%, the degludec will have been given at a distant SC site by standard injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with duration > 6 months and age over 20;
- •sufficient manual dexterity and visual acuity;
- •willingness to wear two CGM devices and perform BG tests for 7 days.
排除标准
- •untreated proliferative retinopathy;
- •untreated mental illness that precludes study adherence
- •untreated cardiovascular disorder such as unstable angina, severe heart failure,
- •infectious diseases such untreated hepatitis, HIV, or active Covid-19;
- •other severe body system disease.
结局指标
主要结局
glucose sensing accuracy
时间窗: 3 days
mean absolute relative error compared to reference glucose values
次要结局
- user satisfaction(3 days)