Type 1 Diabetes Clinical Trial
Official title:
Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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