Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
研究概览
简要总结
The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.
详细描述
The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis. The study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult subjects with type 2 diabetes
- •receiving hemodialysis (for at least 90 days)
- •treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, detemir, degludec, NPH)], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (DPPIV or GLP1)
- •willingness to wear the CGM
- •currently performing self-monitored blood glucose (at least 2 times daily).
排除标准
- •use of sulfonylureas or thiazolidinediones alone or in combination with insulin
- •use of personal/real-time CGM 3 months prior to study entry (blinded CGM is allowed)
- •prior use of insulin pumps or hybrid close loop systems (for at least the prior 28 days)
- •current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed)
- •subjects who are sensitive or allergic to adhesive
- •extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
- •any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual or hearing impairment, active alcohol or drug abuse, mental illness) or pose excessive risk to study staff handling venous blood samples
- •situations that will limit the subject's ability to comply with the protocol (per investigator discretion)
- •active malignancy
- •unable to give informed consent
- •at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) during blinded CGM period
- •significant hypoglycemia (< 40 mg/dL)
- •severe hyperglycemia (BG> 400 mg/dL)
- •extensive skin abnormalities at insertion sites
- •pregnancy or breastfeeding
- •severe anemia (Hemoglobin < 5 mg/dl)
- •polycythemia (Hemoglobin >17 mg/dl)
- •subjects taking acetaminophen (more than 1 gr every six hours)
- •hydroxyurea (may cause interference with the sensor membrane).
结局指标
主要结局
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
时间窗: 8 weeks (after completion of both phases)
Differences in mean percentage time-in-hypoglycemia (\< 70 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM. Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
次要结局
- HbA1C at 3 Months Follow up(Baseline, 3 months post-intervention)
- Number of Hospitalization or Emergency Room Visits for Hypoglycemia(Baseline, 3 months post-intervention)
- Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)(Baseline, 3 months post-intervention)
- % Time in Target Range (70-180 mg/dl)(8 weeks (after completion of both phases))
- Mean % Time in Hypoglycemia (< 54 mg/dL)(8 weeks (after completion of both phases))
- Glycemic Variability [% Coefficient of Variation (%CV)(8 weeks (after completion of both phases))
- % Time in Hyperglycemia (>250 mg/dl)(8 weeks (after completion of both phases))
- % Time in Hyperglycemia (>180 mg/dL)(8 weeks (after completion of both phases))
- Mean Amplitude of Glucose Excursions (MAGE)(8 weeks (after completion of both phases))
研究者
Rodolfo Galindo
Principal Investigator
Emory University