Status:
UNKNOWN
Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.
Lead Sponsor:
University of Malaya
Conditions:
to Identify Which Titration Regimen of Basal Insulin (Being Daily Titration vs 3 Daily Titration) is Better in Reducing hba1c and Have Lesser Hypoglycemia
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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...
Detailed Description
Hypothesis Daily basal insulin titration reduces HbA1c more significantly compared with 3 daily basal insulin titration among T2DM patients. Aims Primary Aim : To evaluate the difference of daily b...
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus patients with
- Adults aged 18 years and above
- HbA1c \>7.5% and Fasting blood sugar \> 8mmol/L
- Newly diagnosed T2DM with osmotic symptoms or HbA1c \>10% or FPG \>13mmol/L
- Insulin naïve patients
- Patients planned for insulin initiation
- Ability to give informed consent
- Ability to perform self-monitoring blood glucose
Exclusion
- Diabetes other than type 2 diabetes mellitus
- Diabetes in pregnancy
- Diabetes with chronic kidney disease stage 3,4 and 5 (eGFR \<60ml/min/1.73m2)
- Patient with history of severe hypoglycemia
- Active proliferative diabetic retinopathy
- Any medical condition that may influence HbA1c measurements (e.g., thalassemia, sickle cell anemia)
- Treatment with systemic corticosteroid
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05331469
Start Date
July 19 2021
End Date
April 30 2023
Last Update
April 15 2022
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Malaysia