임상 레이더 AI | ||
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임상시험 NCT05787990 (TRACK2)은(는) 제2형 당뇨병, Diabetes Related Complications, Diabetes; Retinopathy (Manifestation), Diabetes; Neuropathy, Polyneuropathy (Manifestation), 당뇨병성 신병증 (표현)에 대해 미상 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
Time-In-Range Based Risk Stratification of Type 2 Diabetes Microvascular Complications (TRACK2) 500 관찰 연구
The goal of this observational study is to learn about the role of Time-in-Range to stratify the risk of micro vascular complications in adults with type 2 diabetes. The main questions it aims to answer are:
- Is a lower Time-in-Range associated with a higher risk of diabetes microvascular complications, independent of HbA1c?
- Is Time-in-Range lower among sulfonylurea and premixed insulin therapy users compared t...
Participants: Investigators aim to recruit a maximum of 500 adults with type 2 diabetes on medical therapy with an HbA1c between 6-12%. Pregnant women, people undergoing active cancer therapies, people taking oral or injectable steroids and those with chronic kidney disease on dialysis will be excluded as the glycemic profile and the pathology in these patients are significantly different from a typ...
더 보기Time-in-Range (TIR), a Novel Continuous Glucose Monitoring (CGM) Based Measure, to Improve Risk Stratification of Microvascular Complications in Type 2 Diabetes
- TRACK2
- CNIG20nov-0005
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
해당 없음 | Diabetes Microvascular Complication Tests Continuous glucose monitoring using Freestyle Libre Pro, Foot examination with monofilament and neurothesiometer, HbA1c and Urine Microalbumin Creatinine Ratio, Corneal confocal microscopy, Fundal photography, Optical coherence tomography, Optical cohere |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Presence of Diabetes Retinopathy | Based on Fundal Photography grading | 10 years |
Presence of Diabetes Neuropathy | Based on 10g monofilament foot examination | 10 years |
Presence of Diabetes Nephropathy | Urine microalbumin-creatinine ratio in mg/g | 10 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Continuous glucose monitoring derived glycemic variables | Time-in-Range (70-180 mg/dl) | 14 days |
Severity of Retinal degenerative changes | Based on Optical coherence tomography | 10 years |
Severity of corneal neuropathy | Based on confocal corneal microscopy | 10 years |
Severity of diabetes peripheral neuropathy | Vibration threshold on neurothesiometer | 10 years |
- Type 2 diabetes,
- Age >= 21 years,
- Ability to provide informed consent,
- HbA1c done within 6 months of recruitment between 6-12%
- Undergoing active chemotherapy or immunotherapy for cancer
- Currently taking oral or injectable steroids
- Chronic kidney disease on dialysis
- Women who are pregnant or breastfeeding