August 13, 1996
We've treated 19 young patients with IDDM at the New England Diabetes and Endocrinology Center (NEDEC) in Waltham, Massachusetts, USA. The first protocol was an open labeled crossover study with teens and young adults and the second was a three way open labeled crossover study. The frist study compared Lis Pro Humalog in patients already treated with multidose insulin by algorithm coupled either with NPH or ultralente Humulin. Excellent results, no problems with transfer to Humalog, no major change in insulin dosage, no excessive hypoglycemia and no need to increase background NPH or ultralente insulins we were already using. The study duration was too short to see if there was significant improvement in GHB [glycohemoglobin, or HbA1c. Ed.] but there certainly was no deterioration. Everyone loved the Humalog for the convenience of merely giving the insulin just before meals. Nobody wanted to stop when the study was completed.
The prepubertal study was a collaborative effort in conjunction with Eli Lilly and also Larry Deeb's group in Tallahassee, Florida and Marty Spencer's group in Minneapolis, Minnesota plus three Canadian centers as well. We have not yet analyzed our data but we at NEDEC saw the exact same results: this was a triple crossover study design and also open-labelled. One arm of study was their usual Humulin regular insulin premeals on multi-dose algorithms, second arm was Lis pro Humalog just prior to meals and third arm was Lis Pro Humalog just after meals. No signficiant differences obvious to patients, me or our nurse educator. No obvious deterioration in GHB once again and still too short (only three months) on each randomized treatment arm to say if the GHB would be better or worse. But none worsened. Seemed to be fewer episodes of hypoglycemia and everyone again loved the convenience of insulin just before food. Nobody needed major change in any of their cloudy insulins. In these two separate but relatively short duration studies, we saw none of the side effects noted in the Forecast article and were surprised at how much space these rare type of side effects generated.
Our plan at NEDEC is already to switch patients to Humalog as it has become available in Massachusetts this past week. Pharmacists do not yet know about this new insulin but are learning of it from our patients requests and new prescriptions. Apparently cartridges will not be available from Lilly immediately but will be some time in the Fall so that school/lunch doses and afternoon doses can utilize the pen systems. Patients have been aware of this new insulin from education updates in our office the past year coupled with the few who read Diabetes Forecast and saw the August 1996 article. Two of our young patients and their families were quoted in the Forecast article and are representative of those who used Lis Pro Humalog in the NEDEC studies. We are in the process of analyzing downloaded One Touch II glucose data to see if actual day to day BG values were any different than cataloguing episodes and severity of hypoglycemia, GHB data etc.
For all our patients who are fussy and unpredictable eaters, we will also use Lis Pro Humalog immediatley AFTER eating since the exact amount of food or snack ingested will then be known - no more guessing - and the fast acting aspects of Lis Pro Humalog will be able to compensate for insulin being given afer rather than before food intake.
We will hope to get abstracts prepared not only for the ADA meetings next June 1997 but also for the upcoming ISPAD meetings in Turku and the IDF meetings in Helsinki in July 1997 with a formal paper to follow as well.
We're not sure if mid-morning and mid-afternoon snacks will be needed but some of our patients who did not like to eat at those times were able to omit these snack times successfully.
Stuart Brink, MD
Senior Endocrinologist, NEDEC
Director, Pediatric and Adolescent Diabetes and Endocrinology (PADE) at Newton Wellesley Hospital
Associate Clinical Professor of Pediatrics, Tufts University School of Medicine
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Last Updated: Thursday August 29, 2002 20:59:50
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