Comparison of Insulin Glargine and Regular Insulin Versus NPH and Regular Insulin in the Treatment of T1DM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Insulin Glargine Mixed With Regular Insulin Versus the Standard Neutral Protamine Hagedorn (NPH) and Regular Insulin in the Treatment of Type 1 Diabetes Mellitus

Conditions
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To Assess the Glycemic Control of Insulin Glargine in Combination With Regular Insulin in Type 1 Diabetes in Children

Intervention / Treatment
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* Drug: Glargine and regular insulin versus NPH and regular insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of age 3 to 18 years with Type 1 Diabetes Mellitus Exclusion Criteria: Children below or above 18 years Comorbidities like celiac disease, hypothyroidism

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 34 in each Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glargine<br>Glargine-regular insulin regimen | Drug: Glargine and regular insulin versus NPH and regular insulin<br>* 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.<br>|
| Active Comparator: NPH<br>NPH- regular insulin regimen | Drug: Glargine and regular insulin versus NPH and regular insulin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Baseline HbA1c is compared with the end HbA1c after 3 months of therapy | Three months | 
| Hypoglycemia | Capillary blood sugar level below 70mg/dl | Three months | 
| Fasting blood sugar | Capillary blood sugar before breakfast | Three months | 
| Post-meal blood | Capillary blood sugar level 2 hours after the three main meals | Three months | 
| Mid night blood glucose level | Capillary blood glucose levels between 12:00am -3:00am | Three months |