Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.
Status:
Recruiting
Trial end date:
2023-04-30
Target enrollment:
Participant gender:
Summary
Introduction Diabetes mellitus is a worrying global non-communicable disease where it is
affecting 18.3% of Malaysian adults. Poorly managed diabetes leads to an array of serious
complications, namely heart attack, kidney failure and stroke. Insulin therapy remains one of
the most important medication in treating diabetes especially in the population with high
sugar readings or long standing diabetes. Outpatient consultations for T2DM patients are
spaced out due to the limited amount of treating physicians and clinic time. This resorts to
the importance of outpatient patient-lead insulin titration. Different guidelines from local
and international showed different basal insulin titration method in achieving ideal fasting
blood sugar.
Objective We aim to investigate the difference of basal insulin titration methods in reducing
HbA1c among the T2DM patients.
Methodology In a parallel group randomized controlled trial, we aim to recruit 70 adult T2DM
patients who have poorly controlled T2DM ( HbA1c > 7.5% with FPG >8mmol/L) or newly diagnosed
T2DM patients (who are symptomatic or HbA1c >10% or FPG >13 mmol/L). The subjects will be
randomized to 2 groups, daily basal insulin titration and 3 daily basal insulin titration.
These subjects will be follow up for 12 weeks (4th week and 8th week virtual consultation and
12th week face-to-face consultation). The primary outcome is the HbA1c reduction from
baseline to the end of 12weeks intervention. The secondary outcomes are percentage of T2DM
patients achieving fasting blood sugar within 4.4-7mmol/L and/or HbA1c <7% within the study
period, the incidence of hypoglycemia, total daily basal insulin dosage required to achieve
desired fasting blood sugar, duration taken to achieve desired fasting blood sugar, weight
changes and satisfaction to the therapy between the 2 intervention groups.
Clinical Significance This study enables us to evaluate the efficacy of the different basal
insulin titration methods among the T2DM patients.