Evaluation of an electronic Oral Glucose Tolerance Test Kit (eOGTTK)

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN91288133
• Date of registration: 27/04/2012
• Prospective Registration: No
• Primary sponsor: Novartis Pharma AG (Switzerland)
• Public title: Evaluation of an electronic Oral Glucose Tolerance Test Kit (eOGTTK)
• Scientific title: Evaluation of an electronic Oral Glucose Tolerance Test Kit: a randomized crossover study
• Date of first enrolment: 01/04/2011
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN91288133
• Study type: Interventional
• Study design: Randomized crossover study (Diagnostic)

Countries of recruitment

United Kingdom

Contacts

• Name: M. Angelyn Bethel

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes (type 2)
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Intervention(s)

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 clinic based and nurse-led tests
During the two nurse-led visits, venous blood samples for a standard laboratory OGTT were collected at the same time. Tests were scheduled between 2 and 7 days apart, resulting in a maximum duration of observation up to 7 weeks. Focus groups to assess user acceptability were scheduled within 4 weeks of the last test.

Samples from the 0 and 120 minute time points of the eOGTTK tests were compared to asses the degree of variation in different settings (repeatability) and the degree of variation (reproducibility) within each setting. Samples from the 0 and 120 minute time points of the eOGTTK test and the laboratory test were compared to evaluate the accuracy of the eOGTTK values.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

TRG 10/02

Source(s) of Monetary Support

Novartis Pharma AG (UK)