Published online February 25, 2008
PEDIATRICS (doi:10.1542/peds.2007-1679)
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ARTICLE

A Randomized, Controlled Trial Comparing Twice-a-Day Insulin Glargine Mixed With Rapid-Acting Insulin Analogs Versus Standard Neutral Protamine Hagedorn (NPH) Therapy in Newly Diagnosed Type 1 Diabetes

Krishnavathana Hassan, MD, Luisa M. Rodriguez, MD, Susan E. Johnson, RN, CDE, Susanne Tadlock, RN, CDE and Rubina A. Heptulla, MD

Department of Pediatric Endocrinology and Metabolism, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas

OBJECTIVE. Insulin glargine is difficult to use for children due to the number of injections required because it is claimed to be immiscible with rapid-acting insulin analogs. For this study, we hypothesized that treating new-onset type 1 diabetes with twice-daily insulin glargine plus a rapid-acting insulin analog mixed in the same syringe would result in better glycosylated hemoglobin than twice-daily neutral protamine Hagedorn with a rapid-acting insulin analog (standard treatment).

METHODS. Forty-two patients with new-onset type 1 diabetes were started on standard treatment. Three months after diagnosis, if patients were found compliant and had a glycosylated hemoglobin level of ≤9%, then they were randomly assigned either to receive insulin glargine twice daily mixed with a rapid-acting insulin analog or to continue on standard treatment for 3 more months. Additional lunchtime rapid-acting insulin analog injections were given for the insulin glargine group as necessary.

RESULTS. Nineteen patients in the insulin glargine group and 17 in the neutral protamine Hagedorn group completed the study. The glycosylated hemoglobin level at baseline was 6.8% ± 1% vs 6.9% ± 1% and at poststudy was 6.7% ± 1.3% vs 7.6% ± 1% in the insulin glargine versus neutral protamine Hagedorn group, respectively. Two patients in the insulin glargine group required lunch rapid-acting insulin analog in the last month of the study. Although both groups were encouraged to contact the principal investigator with all queries, more in the insulin glargine arm opted to do so.

CONCLUSIONS. Glycemic control with insulin glargine mixed with a rapid-acting insulin analog given twice daily seems significantly more effective than the standard therapy in newly diagnosed type 1 diabetes. Furthermore, it decreases pain and burden of injections for children with diabetes by allowing patients to mix glargine with rapid-acting insulin analog.

Key Words: children • diabetes • insulin

Abbreviations: DCCT—Diabetes Control and Complications Trial • GHb—glycosylated hemoglobin • NPH—neutral protamine Hagedorn • RAIA—rapid-acting insulin analog • BG—blood glucose • IG—insulin glargine • PI—principal investigator • QoL—quality of life • FBG—fasting BG • LBG—prelunch BG • SBG—presupper BG • PedsQL—Pediatric Quality of Life Inventory

Accepted Jul 21, 2007.