Diabetes (type 2) Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Participants used the eOGTTK on six occasions in three settings:
1. Two home based (and unobserved) tests
2. Two clinic based and observed tests (preferably without any nurse intervention)
3. Two clin
Sponsors
Novartis Pharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study 2. Aged 18 years or above 3. Had adequate vision and reading comprehension to follow the electronic OGTT kit instructions in English 4. Patients with type 2 diabetes were: 4.1. Treated with diet alone or with metformin monotherapy 4.2. Had stable therapy for at least 3 months prior to study enrollment or 5. Individuals without diagnosed diabetes had no prior experience of an OGTT or any tests which involved finger-pricking
Exclusion criteria
Exclusion criteria: 1. Pregnancy or planned pregnancy during the study period 2. Participant taking drugs that may affect glucose levels 3. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator, posed an unacceptable risk to the individual, confounded the results of the study, or was likely to interfere with the individual?s participation of the full duration of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the precision of the eOGTTK by assessing: 1. Repeatability: the degree of variation when assessed in different settings 2. Reproducibility: the degree of variation within each setting | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the user acceptability of the eOGTTK through the use of a validated device satisfaction questionnaire and focus groups 2. To investigate any possible training effects with repeated eOGTTK use 3. To evaluate the accuracy of the eOGTTK 0? and 120? values compared with laboratory measured venous plasma glucose values | — |
Countries
United Kingdom
Outcome results
None listed