THYME

• Research type

  Research Study

• Full title

  Pilot Study to Determine Time in Hypoglycaemia when using Pre-Mixed (Biphasic) Insulin

• IRAS ID

  259997

• Contact name

  Iskandar Idris

• Contact email

  Iskandar.Idris@nottingham.ac.uk

• Sponsor organisation

  Abbott Diabetes Care Ltd

• Duration of Study in the UK

  0 years, 5 months, 31 days

• Research summary

  This is a single arm, multicentre pilot study to evaluate the amount of time spent having low glucose by persons with Type 2 Diabetes, managed with pre-mixed (biphasic) insulin.

  The study will be conducted at primary and secondary care NHS sites in England and Scotland, and will aim to recruit approximately 40 persons with type 2 diabetes on a biphasic insulin regimen (with a screening HbA1c of less than
  58 mmol/mol (7.5%).

  Participants will have FreeStyle Libre Pro sensors applied by their HCP (one on each arm) and will wear them for 14 days while going about their daily activities. At the end of the sensor wear period, participants will return to their HCP to have the sensors removed and their data uploaded.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  19/SW/0086

• Date of REC Opinion

  25 Apr 2019

• REC opinion

  Favourable Opinion