Lantus in the Treatment of Type 1 Diabetes Children
Lantus in the Treatment of Type 1 Diabetes Children
In this study, we plan to examine the difference in effect on blood glucose control in
 patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice
 daily, injected separately) or on intensive insulin management (IIM-several shots of short
 acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the
 short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be
 used to monitor blood glucose control over a 6 month period. Twice during the course of the
 study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records
 blood sugar readings every 5 minutes) will be used to record all the changes in the blood
 glucose levels occurring over a 72-hour period.
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.