Examples of Studies

 

The Diabetes Research Group Lab is involved in a diverse range of research studies and trials. Some examples of these studies and the involvement of the lab in them are summarised below

 

CLOuD


Multicentre study, assessing the effect of closed loop insulin delivery from onset of T1DM in youth on residual beta-cell function versus standard insulin therapy in approximately 100 participants for a 3 year study duration

  • Provision of sample collection equipment (tubes, labels, lab manuals etc)
  • Organising periodic frozen sample collection from sites using courier service
  • Analysis of HbA1c (every 3 months) and C-peptide and glucose from MMTT (every 6 months)

 

GTT at home 


To determine the accuracy of a novel, disposable single use, ‘at home’ oral glucose tolerance test (OGTT) device in comparison to two laboratory reference methods

  • 100 participants recruited
  • Attended Joint Clinical Research Facility to undergo an OGTT
  • Blood glucose measurements performed on novel OGTT device and reference laboratory glucose analysers
  • Device scanned and results uploaded to a database
  • Results and diagnosis compared to reference laboratory methods

 

Blood glucose meter validation studies to ISO (ISO15197)

 

To determine the system accuracy of blood glucose meters in comparison to a laboratory reference method

  • Approximately 100 volunteers recruited
  • Capillary blood from a finger collected into a capillary collection tube
  • Glucose measured on a reference lab analyser
  • Multiple measurements made on study glucose meters
  • Additional sample collected for a second glucose measurement on reference lab analyser
  • Meter results to fall within 0.22mmol/L (at glucose concentrations <5.55mmol/L) or within 4% (glucose concentrations ≥5.55mmol/L) of the reference lab analyser

 

Cardiovascular health in a prison population

 

Identifying the cardiometabolic risk in the population of a long stay UK prison

  • Provision of sample collection and sample transport materials
  • Receipt of capillary blood samples via the postal service
  • Analysis of HbA1c on approximately 300 samples