Patients with potential ketosis, including diabetes patients and those presenting with diabetic ketoacidosis (DKA) Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Current interventions as of 15/04/2025:
Participants will provide a venous or capillary blood sample that will be tested on the blood ketone monitoring system/s. Participants, particularly those with
Sponsors
Abbott Diabetes Care Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any potentially ketotic person. 2. =16 years of age.
Exclusion criteria
Exclusion criteria: 1. Known to be infected with hepatitis B virus (Hep B), hepatitis C virus (Hep C) or human immunodeficiency virus (HIV). 2. Member of the study staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/04/2025: The results from blood ketone monitoring systems will be compared to plasma measurements obtained by a laboratory reference method using Bland-Altman analysis. Previous primary outcome measure: The accuracy performance of the blood ketone monitoring system compared to plasma measurements obtained by a laboratory reference method by using the Bland-Altman plot. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood samples will be used to compare results obtained on the blood ketone monitoring systems (y) with plasma results obtained on the reference system (x) by performing linear regression analysis (y vs. x). The slope, intercept, correlation coefficient, and confidence intervals for the slope and intercept will be calculated. | — |
Countries
England, United Kingdom
Contacts
Public ContactPamela Reid
Outcome results
None listed