CGM-Guided Acarbose for Painful Diabetic Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Daily pain AUC
研究概览
简要总结
This Phase II pragmatic hybrid effectiveness-implementation trial tests whether acarbose, titrated using continuous glucose monitoring (CGM) to blunt post-prandial excursions, reduces 4-week pain area-under-the-curve (AUC) versus placebo in adults with painful diabetic peripheral neuropathy (DPN) and high glycemic variability. Secondary objectives assess CGM variability metrics, microvascular reactivity, inflammatory markers, safety, and feasibility of a pharmacist-led titration workflow using loaner CGMs across multi-region community clinics.
详细描述
Adults with T2D, painful DPN, and high CGM variability (e.g., MAGE >50 mg/dL on run-in) are randomized 1:1 to acarbose vs matching placebo for 4 weeks, on stable background analgesics. A standardized pharmacist-led algorithm escalates acarbose to target post-prandial spikes, guided by blinded CGM trend review. The primary endpoint is 4-week daily pain AUC captured via ePRO. Key secondary endpoints include changes in MAGE and time-in-range (TIR), skin microvascular reactivity (laser speckle), serum IL-6, patient global impression of change, rescue-analgesic use, and adverse events. Implementation outcomes (acceptability, feasibility, adoption, cost) are collected to inform scale-up in HIC and LMIC community settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age 18-75 years.
- •Type 2 diabetes ≥1 year; HbA1c 7.0-10.0% within 8 weeks of randomization.
- •Painful DPN meeting clinical criteria; average daily pain NRS ≥4 during run-in.
- •High CGM variability on 7-10 day run-in (e.g., MAGE >50 mg/dL).
- •Stable analgesic regimen ≥4 weeks pre-baseline.
- •Able to use CGM and ePRO; provides informed consent.
排除标准
- •Type 1 diabetes; non-diabetic neuropathies.
- •Contraindications to acarbose (e.g., chronic intestinal malabsorption, inflammatory bowel disease).
- •eGFR <45 mL/min/1.73 m²; significant hepatic disease (ALT/AST >3× ULN).
- •Use of α-glucosidase inhibitors within 3 months.
- •Recent change (<3 months) in GLP-1/GIP agonists, SGLT2i, or basal/bolus insulin strategy.
- •Pregnancy/lactation; other conditions compromising safety/assessments.
研究组 & 干预措施
Arm A
Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated) to curb post-prandial excursions based on CGM review.
Background analgesics held stable.
干预措施: Acarbose 50 mg (Drug)
Arm B
Matching placebo; identical titration schedule. Background analgesics held stable.
干预措施: Placebo (Drug)
结局指标
主要结局
Daily pain AUC
时间窗: baseline→Week 4
Daily pain AUC (ePRO; 0-10 NRS). Method: trapezoidal AUC of daily NRS scores; higher AUC = worse pain. Daily pain area under the curve derived from the Numeric Rating Scale for Pain (NRS). The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. AUC is calculated using the trapezoidal method from daily NRS scores over the assessment period. Higher AUC values indicate greater overall pain burden.
CGM MAGE (mg/dL)
时间窗: baseline→Week 4
CGM MAGE (mg/dL)
次要结局
- Skin microvascular reactivity(baseline→Week 4)
- Serum IL-6(baseline→Week 4)
- CGM Time-in-Range (70-180 mg/dL, %)(baseline→Week 4)
- Patient Global Impression of Change (PGIC)(Week 4)
研究者
Saima Abass Tahammal
Medical director
Shifa International Hospital