Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control

NCT02117154 | Completed

• 1 other identifier: MEC 988.5
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate relative contributions of fasting plasma glucose and postprandial glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between HbA1c, CGM, serum fructosamine and eAG, will also be looked into. HYPOTHESES:

1. 1.Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role with lower HbA1c levels.
2. 2.There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian patients.

Conditions

Diabetes Mellitus, Type 2

Keywords

Continuous Glucose Monitoring System; HbA1c; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Area Under The Curve for Glucose excursion

  Measurement on total 24hours, total postprandial period in 24 hours and 4 hours postprandial period for each meal

Secondary Outcomes (1)

• Measurement of HbA1c, fructosamine, Glycated albumin levels

  Each test is repeated 3 times on monthly basis, ie month 0,1 and 2.

Study Arms (1)

HbA1c, 6-day Professional CGM

6-day Continuous Glucose Monitoring System (Medtronic iPro2 Professional CGM) will be deployed on a same patient for 3 times, which is one month apart

Device: 6-day Continuous Glucose Monitoring System

Interventions

6-day Continuous Glucose Monitoring System DEVICE

performed 3 times on a patient, one month apart

Also known as: Medtronic iPro2 Professional CGM

HbA1c, 6-day Professional CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited from Diabetes Clinic, University of Malaya Medical Center

You may qualify if:

• Age ≥ 18 years old
• Diagnosed with T2DM with stable HbA1c
• On OAD, insulin or combination therapy for a minimum of 3 months
• HbA1c ≥ 6%
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min
• Normal haemoglobin level Male: 13.0 - 18.0 g/dL Female: 11.5 - 16.5 g/dL Mean corpuscular volume (MCV): 77 - 95 femtoliters (fL) Mean corpuscular hemoglobin (MCH): 27 - 32 pg Mean corpuscular hemoglobin concentration (MCHC): 32 - 36 g/dL

You may not qualify if:

• Newly diagnosed T2DM (\<3 months)
• T1DM patients
• Not on OAD or insulin therapy
• Hospitalized patients
• Patients with other co-morbidities, eg chronic liver disease, advanced cardiac disease, malignancy, on steroid therapy
• eGFR\< 60ml /min
• Patients with anaemia
• Known haemoglobinopathies, eg alpha and beta thalassemia, sickle cell disease, Hemoglobin-E thalassemia etc
• Patients with history of blood transfusion in the preceding three months
• Patients who are likely to receive or donate blood / blood products during the study period
• Patients who are on erythropoietin therapy
• Patients who are pregnant or plan for pregnancy

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• ALEXANDER TONG BOON TAN, MRCP (UK)

  University of Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 17, 2014
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

MY (1)