CTRI/2022/06/043064尚未招募未知
A Pilot Study to Clinically Evaluate Bolus Insulin Therapy Delivered by InsuPress Wearable Injector in Patients with Type-I/II Diabetes
Mediscient Devices OPC Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Individuals who are either male or female
- •Female individuals should not be pregnant
- •Individuals with Type 1/2 DM , undergoing treatment with basal insulin for at least 2 months (with/without antihyperglycemic agents), with a stable dose [ >0.3 units/kg/day; <100 units/day]maintained for at least two weeks
- •Individuals having HbA1c levels 8-11% (53-97 mmol/mol) at the time of screening for the study
- •Individuals who are willing to self-monitor blood glucose daily using a glucometer during the study period
- •Individuals who are willing to participate in the study
- •Individuals who are able to follow instructions from the study coordinator
- •Individuals with BMI <40 kg/m2
排除标准
- •Individual has experienced recurrent severe hypoglycemia ( >2 episodes) requiring assistance during the last 12 months
- •Individuals who are undergoing treatment with meal time insulin or continuous subcutaneous insulin infusion within the last 12 months outside of an acute illness or hospital setting
- •Individual has clinical cardiovascular disease as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ECG at rest
- •Individual has clinical abnormalities (moderate to severe illness) on the screening visit that are deemed by the investigator to be clinically significant
- •Individual is currently being treated with or expected to require or undergo treatment with systemic steroids
- •Individual currently abuses drugs or alcohol or has a history of abuse that in the investigatorâ??s opinion would cause the individual to be non-compliant
- •Individual has participated in any other clinical trial in the last 2 months involving any investigational drug or device
研究者
相似试验
尚未招募
不适用
Observational Study and follow up of a Sepsis Biomarker for Sepsis Diagnosis in the Intensive CareInfection - Other infectious diseasesDiabetesSepsisACTRN12609000576224Intensive Care Unit, Christchurch Hospital200
已完成
不适用
Clinical Study for the Comparison of Blood Insulin Pharmacokinetics in different insulin pen needlesType 1 and 2 diabetesJPRN-UMIN000004469Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine12
进行中（未招募）
不适用
A Randomized Trial Comparing either Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects with Type 2 Diabetes who were previously treated by basal insulin Glargine with either metformin or metformin and sulfonylurea - NDMedDRA version: 9.1Level: LLTClassification code 10012594Type 2 DiabetesEUCTR2009-009500-39-ITELI LILLY760
已完成
3 期
A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with Cystic Fibrosis-Related Diabetes10038686Cystic Fibrosis10018424NL-OMON38078HagaZiekenhuis25
进行中（未招募）
不适用
A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRDCystic fibrosis-related diabetesMedDRA version: 9.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosisEUCTR2009-009875-37-NLStaf Longziekten25