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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Treatments: Insulin

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus patients with

1. Adults aged 18 years and above

2. HbA1c >7.5% and Fasting blood sugar > 8mmol/L

3. Newly diagnosed T2DM with osmotic symptoms or HbA1c >10% or FPG >13mmol/L

4. Insulin naïve patients

5. Patients planned for insulin initiation

6. Ability to give informed consent

7. Ability to perform self-monitoring blood glucose

Exclusion Criteria:

1. Diabetes other than type 2 diabetes mellitus

2. Diabetes in pregnancy

3. Diabetes with chronic kidney disease stage 3,4 and 5 (eGFR <60ml/min/1.73m2)

4. Patient with history of severe hypoglycemia

5. Active proliferative diabetic retinopathy

6. Any medical condition that may influence HbA1c measurements (e.g., thalassemia, sickle cell anemia)

7. Treatment with systemic corticosteroid