Real world Evidence Generation of data on use of Advanced Hybrid Closed Loop (AHCL) Technology in T2DM in India
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The data collected at or near the 3 months post-automation. Time in Range 70-180 mg/dl) of the patient at the prespecified date.
研究概览
简要总结
The Advanced Hybrid Closed Loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia. AHCL has shown promising outcomes in improving glycemic outcomes in type 1 diabetes
MiniMed 780G is currently intended for the management of Type 1 diabetes mellitus (T1DM) in persons requiring insulin, ages seven years and older. However, in India there are more than 50 people with type 2 diabetes, who are currently using AHCL system to manage type 2 diabetes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with T2DM Participants who are using AHCL system Multiple daily dose insulin HbA1c values between ≥8.0% and ≤14%.
排除标准
- •A history of two or more hypoglycaemia-related seizures or comas within the last 6 months.
- •Patients who are pregnant or planning to become pregnant are also excluded.
- •Use of steroids or weight loss medication, abuse of alcohol or drugs.
- •Patients currently under a psychiatrist’s care or using antipsychotic or mood stabilizer medication or diagnosed to have dementia or bipolar disorder or schizophrenia.
结局指标
主要结局
The data collected at or near the 3 months post-automation. Time in Range 70-180 mg/dl) of the patient at the prespecified date.
时间窗: 1 Year
HbA1c change between 2 arms after 6 months.
时间窗: 1 Year
次要结局
- HbA1c after 3 months and change from baseline to final visit(Total daily dose)
研究者
Dr V Mohan
Madras Diabetes Research Foundation