POET: Use of point of care testing for monitoring and management of long-term conditions

Not Applicable

• Conditions: Diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13913027
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-17
• Last Update Posted: 12 August 2024
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

1. Aged >18 years of age
2. People with long-term conditions (LTC) (a subset will be consented separately for feasibility phase) or healthy individuals attending UHL or primary care centres for routine bloods or assessments e.g. elective surgery
3. Able to understand written and spoken English
4. Able to give informed consent
5. Participant agrees to have Capillary and Venous blood samples collected.

Exclusion Criteria

1. Pregnant women with gestational diabetes or established diabetes
2. Those on dialysis or end stage renal disease (eGFR< 15ml/min/m2)
3. Liver cirrhosis
4. Diagnosed cancer
5. Haematological malignancies
6. Needle phobia
7. Clotting disorders and bleeding tendencies (platelet count < 100 x 109/L)
8. Conditions in which HbA1c measurement is not reliable
9.1. Hemoglobinopathies like sickle cell and thalassemia
9.2. Severe hypertriglyceridemia (> = 20mmol/l)
9.3. Splenectomy
9.4. Chronic alcohol intake of more than 14 units per week
9.5. Blood transfusion within past 12 weeks
9.6. Recent blood loss (< = 4 weeks)
9.7. Ribavirin and interferon-alpha use
9.8. Iron, B12 and folate deficiency anaemias

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of capillary blood samples against venous samples:1. HbA1c2. Potassium3. Sodium4. Urea5. Creatinine6. Total Cholesterol7. Low Density Lipoprotein (LDL) – Cholesterol8. High Density Lipoprotein (HDL) – Cholesterol9. Triglyceride (TG)10. ALT (Alanine Aminotransferase)11. CRP12. TSH (Thyroid Stimulating Hormone)Validation Phase: Months 1 – 12Feasibility Phase: Months 13 - 18

Secondary Outcome Measures

Name	Time	Method
Feasibility outcomes measured in months 13 - 181. Service User experience: Surveys and interviews2. Adherence rate: Proportion of responders returning the remote samples. 3. Cost-effectiveness analysis: Compared to standard venous samples