Health Condition 1: E08-E13- Diabetes mellitus
Conditions
Interventions
Intervention1: Insulin pen with full dose delivery alerts: The pen features an intuitive dose delivery feedback system, including a green light and beep sound that indicate when a full dose has been s
Sponsors
Saveetha medical college and hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of diabetes mellitus requiring subcutaneous insulin therapy 2. Currently using insulin pens willing to switch to pen delivery for the study. 3. clinician judgment that glycaemia is stable enough to participate). 4. Willingness and ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Current use of an insulin pump or other implanted insulin-delivery device. 2. Known allergy or hypersensitivity to any materials used in the investigational pen or its consumables. 3. Pregnancy, lactation, or planning pregnancy during the study period. 4. Severe visual impairment, severe cognitive impairment, or other conditions that preclude safe/accurate self-administration of insulin or operation of the device and cannot be remedied by a caregiver.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It enhances accuracy,usability and reduce risk of under or over dosing enhancing patient confidence and safetyTimepoint: improves glycemic control within one month | — |
Secondary
| Measure | Time frame |
|---|---|
| Unlike existing smart pens that rely heavily on digital integrations for dose tracking, this invention prioritizes ease of operation & immediate feedback, bridging the gap between advanced technology & user-centric designTimepoint: One month | — |
Countries
India
Contacts
Public ContactDr Gada Kanaka Durga Chandu
saveetha medical college and hospital
Outcome results
None listed