Patient empowerment in dose adjustment of premixed insulin

Background: To compare the patient-led titration (intervention group) versus physician-led titration (control group) in optimizing the use of premixed insulin in patients with uncontrolled Diabetes treated DM-2. Methods: This Prospective, Randomized, open-label controlled trial was carried out for 6 months at Endocrinology and Medicine Clinics of Shifa Hospital .Total of 50 patients ,25 in patient-led titration (intervention group) versus 25 in physician-led titration (control group) after written informed consent, fulfilling other inclusion criteria and exclusion criteria were enrolled. Fasting blood sugar were checked on Monday, Tuesday and Wednesday before injecting premixed insulin, average of three readings were calculated , if the average was more than 110mg/dl then 2 units of insulin was increased at night. When the average was between 80- 110mg/dl, night dose remained same and for below 80mg/dl, decreased 2 units of insulin. Simultaneously pre-dinner blood sugar was checked on Thursday, Friday and Saturday to adjust the morning dose. Patients were advised for follow up initially weekly for two weeks then monthly visits for two months. At the beginning and end of study, patient were advised to check fasting,pre-dinner blood sugar and ( PRE / Post HBA1c ) Both groups were provided with a booklet containing basic information about insulin hypoglycemia, injection technique and telephonic access to the clinical team. Results: The primary efficacy criterion will be the change of HbA1c from baseline to study endpoint. Comparative analysis between the two groups PRE / Post HBA1c will be analysed by paired T-test. Significance of p value will be less than 0.05. Conclusions: SMBG is an important self-management tool for insulin-treated patients with DM-2. With SMBG & guidance, patients can adjust their insulin dose quickly to achieve the good glycemic control Keywords: Self-monitoring of blood glucose glycated Heamoglobin (HBA1c ). DM-