Health Condition 1: E08-E13- Diabetes mellitus
Conditions
Interventions
Intervention1: InsuPress: A wearable bolus injector.
Non-notified Device
Registration/Listing Number:MEDISC-Vadod-GJ/M/MD/007681
Intervention: 3 Months
Control Intervention1: Not Applicable: Not Appl
Sponsors
Mediscient Devices OPC Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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; 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the long term effect of InsuPress on glycemic control in Diabetes MellitusTimepoint: 3 Months HbA1c values measured at the beginning and at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the immediate effect of InsuPress on glycemic control in Diabetes Mellitus 2.To evaluate the effect of InsuPress on the glycemic state of the patient 3. To evaluate the effect on InsuPress on general health Timepoint: 3 Months 1. Self-Monitoring of Blood Glucose 2.Incidence of hypoglycemia during the study period 3.Measurement of body weight | — |
Countries
India
Contacts
Public ContactDr Amalkumar Bhattacharya
Parul Institute of Medical Science and Research
Outcome results
None listed