Comparison of Insulin Glargine and Regular Insulin Versus NPH and Regular Insulin in the Treatment of T1DM
Condition: To Assess the Glycemic Control of Insulin Glargine in Combination With Regular Insulin in Type 1 Diabetes in Children
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the glycemic control in children with type 1 diabetes using insulin Glargine and
      regular insulin as basal bolus therapy versus Neutral Protamine Hagedorn insulin (NPH) and
      regular insulin.
    

Detailed description: 
      Diagnosed patients with Type-1 diabetes mellitus (T1DM), who had been on insulin therapy for
      more than three months, and met the eligibility criteria, were enrolled and randomly divided
      into group A and group B using the lottery method performed by the nursing staff.

      Baseline HbA1c level was done for all the patients using CERA-STAT 2000 analyzer. The funding
      from KEMU was used to arrange insulin glargine and glucometer strips. The blood glucose
      levels of the patients were measured using the glucometer Freestyle Optium Neo H
      (manufactured by Abbott). Patients and their guardians were taught how to use the glucometer
      and record the measurements on monitoring sheets.

      The total daily insulin dose was calculated according to the patient's age and pubertal stage
      for both groups. Patients in Group A (glargine-regular regimen) received insulin glargine
      (GLA) once in the evening (8:00 pm) and regular insulin 30 minutes before their three main
      meals. The starting dose of the GLA was 30% of the total daily insulin dose and titrated by
      5-10 % according to the self-monitored fasting blood glucose levels to meet the
      age-appropriate goal range and avoid nocturnal hypoglycemia.

      Patients in Group B (NPH-regular regimen) continued receiving NPH with regular insulin twice
      daily using the split and mix method, 30 minutes before breakfast and before dinner. NPH
      comprised 70% of the total daily dose. NPH titration was similar to that of the GLA group.

      Each patient measured their capillary blood glucose levels 4-6 times per day as follows:
      pre-breakfast and 2-hours after breakfast, pre-lunch and 2-hours after lunch, pre-dinner and
      2-hours after dinner. This monitoring continued for 90 days of the trial period.

      Mid-night glucose levels were checked once weekly between 12 am and 3 am to check for
      hypolycemia or hyperglycemia, and that gave us 12 readings for the 90 days trial.

      Each monitoring sheet presented the readings of pre-meals and 2-hours-post meals capillary
      blood glucose levels for each patient for 30 days. (annexure-B) All patients were followed up
      fortnightly at the Pediatric endocrine and diabetes section, Pediatric department, Mayo
      Hospital. Patients' compliance, insulin administration, and storage were assessed on each
      visit by asking the patient and the guardian. If needed, they were taught by the doctor and
      nurse attending the clinic. Both groups were instructed to walk daily for 20- 30 minutes and
      have three main meals and three snacks with avoidance of high carbohydrate dietary items. The
      patients had to mark their compliance with the instructed exercise and diet plan in the
      monitoring sheets.

      The monitoring sheets were collected monthly during the study trial. After 90 days of the
      study, their HbA1C levels were tested using the same analyzer mentioned above for the
      baseline HbA1c.
    

Intervention name(s): Glargine and regular insulin versus NPH and regular insulin
Intervention type(s): Drug
Intervention description(s): Patients with type 1 diabetes (T1DM) in group A received insulin glargine as basal therapy at night and regular insulin given prior to each main meal.
Patients in group B were given NPH and regular insulin in split and mix method in the morning and evening.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 34 in each Arm
Masking: None (Open Label)
Primary purpose: Treatment