Clinical trial NCT05709938: Comparison of Insulin Glargine and Regular Insulin Versus NPH and Regular Insulin in the Treatment of T1DM
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: To Assess the Glycemic Control of Insulin Glargine in Combination With Regular Insulin in Type 1 Diabetes in Children
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 34 in each Arm
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Three months
measure: Hypoglycemia
timeFrame: Three months
measure: Fasting blood sugar
timeFrame: Three months
measure: Post-meal blood
timeFrame: Three months
measure: Mid night blood glucose level
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pediatric endocrine and diabetes section, Pediatric department, Mayo Hospital
state: Punjab
Study officials:
References:
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