TCTR20220628003已完成1 期
The Efficacy of Tele-monitoring And Structured Feedback Loop in People with Insulin-treated Type 2 Diabetes Mellitus with Suboptimal Control
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Roche
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Age 18-65
- •2. Has been diagnosed with type 2 diabetes for more than 6 months.
- •3. Hemoglobin A1C levels were between 7.5-10% within 6 weeks prior to participating in the study.
- •4. Get Insulin Treatment (either alone or in combination with other oral medications) for at least 3 months
排除标准
- •1. Can't penetrate fingertip sugar
- •2. There is no mobile phone that supports applications and data transmission via the Internet
- •3. Unable to communicate with the researcher according to the research plan
- •4. People with a history of taking other drugs that affect glucose levels within 3 months before participating in the study as follows Steroid, Vitamin C excluding vitamin C from natural or fruit sources, Vitamin E, Bactrim, Hydroxyurea
- •History of diabetic ketoacidosis, hyperglycemic hyperosmolar state in the past 6 months
- •6. The patient was diagnosed with psychiatric disorders such as depression, bipolar disorder, and schizophrenia.
- •7. Pregnant or planning to become pregnant within 12 months or breastfeeding
- •8. Based on the history and clinical manifestations recorded in the medical record Patients with the following chronic diseases Chronic renal failure with a glomerular filtration rate of less than 30 ml/min/1.73 m2, cirrhosis or hepatitis with alanine aminotransferase or aspartate aminotransferase 3 times the upper limit of normal, alcoholism, hypothyroidism with Thyroid values. stimulating hormone greater than 10 uIU/ml, HIV infection, anemia with hemoglobin less than 10 g/dL, iron deficiency, vitamin B12 deficiency, folic acid deficiency, thalassemia, Enzyme Depletion glucose-6-phosphate dehydrogenase, hemolysis and hemoglobin greater than 16 g/dL
- •9. Have a history of donating blood or received blood in the past 3 months
- •10. According to medical records, there was uncontrolled diabetic retinopathy or maculopathy.
- •11. Signs or history of cancer in the 5 years prior to the screening date except for basal cell, squamous cell, and other in situ carcinomas
- •12. Has a history of major surgery within 90 days or plans to have a major surgery within 6 months
研究者
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