A Pilot Study To Clinically Evaluate InsuPress Wearable Injector In Patients With Type-I/II Diabetes
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitus
- Registration Number
- CTRI/2022/06/043064
- Lead Sponsor
- Mediscient Devices OPC Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the long term effect of InsuPress on glycemic control in Diabetes MellitusTimepoint: 3 Months <br/ ><br>HbA1c values measured at the beginning and at the end of the study
- Secondary Outcome Measures
Name Time Method 1. To evaluate the immediate effect of InsuPress on glycemic control in Diabetes Mellitus <br/ ><br>2.To evaluate the effect of InsuPress on the glycemic state of the patient <br/ ><br>3. To evaluate the effect on InsuPress on general health <br/ ><br>Timepoint: 3 Months <br/ ><br>1. Self-Monitoring of Blood Glucose <br/ ><br>2.Incidence of hypoglycemia during the study period <br/ ><br>3.Measurement of body weight