Implementation of the Mallya Smart cap in Children ( IMS Child)
Research type
Research Study
Full title
Implementation of the Mallya smart cap insulin device in a paediatric population- a pilot study of feasibility
IRAS ID
263920
Contact name
Edward Holloway
Contact email
Sponsor organisation
Croydon Health Services NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The concept is that recording insulin usage and reminders to administer insulin would help improve diabetic control.
Children with type 1 diabetes that routinely attend a local Paediatric diabetic clinic would be invited to take part. Informed consent from parents and assent from the children would be obtained before enrollment into the study. Study participants would be educated in the use of the Mallya device: this records and reminds on insulin administration. Routine care and routine visits remain unchanged. At the end of the study, a comparison would be made of the baseline values of the HBA1C as well as questionaire administration into the use of the device as seen by the patient.This is thus a feasabilty study into the use of an automated recorder (Mallya) of insulin use in type 1 diabetic patients.
As the Mallya device at present only fits certain types of insulin pens, then those participants would have their insulin pen changed to that which can be used for the purposes of the study.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/1520
Date of REC Opinion
24 Oct 2019
REC opinion
Further Information Favourable Opinion