Lantus in the Treatment of Type 1 Diabetes Children

The landmark report of the diabetes control and complications trial (DCCT) trial has shown that intensive management delays and/or prevents complications in small vessels associated with Type 1 diabetes (T1DM). To achieve the goals of the DCCT, a number of new insulin analogs( man-made insulins ) are now being incorporated into the management of patients with T1DM.

These insulin analogs are gaining importance with their ability to overcome the major obstacle to intensive insulin therapy, namely low blood glucose. In particular, insulin Glargine, considered a basal insulin, is being extensively used for management as an alternative to continuous insulin therapy injected into the tissue just below the skin. The major drawback to using insulin Glargine is that it has to be given as a separate injection and cannot be mixed with other insulins. This results in the undesirable administration of multiple insulin injections to a child with diabetes making the therapeutic plan more complex and adhering to the treatment plan more difficult.

In a previous study, (now accepted for publication in a leading diabetes journal, Diabetes Care), we have demonstrated, using continuous glucose monitoring system, that there is no significant difference in glucose concentrations (ie. high and low blood glucose episodes) when insulin Glargine is administered either mixed with a short-acting insulin analog or when giving it as a separate injection.

Inclusion criteria

• Age greater than 6 years of age but less than 25 years of age (Insulin glargine has been approved for use in children 6 years and older).
• Patients newly diagnosed with T1DM within the past 3 months.
• Have an HgbA1c of less than 9.0%, after the initial run-in period of 3 months.
• Have a BMI of less than the 90th percentile for age.
• Randomization of subjects willing to participate in the study.

Exclusion criteria

• Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc) that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis.
• Lack of supportive family.
• Evidence or history of chemical abuse.
• Age less than 6 years or greater than 25 years.
• HbA1c level of greater than 9.0%, after the initial run-in period of 3 months.
• Have a BMI greater than the 90th percentile for age.
• Patients who are not newly diagnosed with T1DM.