A Pilot Study of the Continuous Glucose Monitoring System
Clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects
- Francine R. Kaufman, MD,
- Leena C. Gibson, MA,
- Mary Halvorson, RN, MSN, CDE,
- Sue Carpenter, BA, RN, CDE,
- Lynda K. Fisher, MD and
- Pisit Pitukcheewanont, MD
- Division of Endocrinology and Metabolism, Childrens Hospital Los Angeles and the Department of Pediatrics, University of Southern California School of Medicine, Los Angeles, California
OBJECTIVE—To determine whether the continuous glucose monitoring system (CGMS) (MiniMed, Sylmar, CA) could be used to make clinical decisions and whether it has an impact on glycemia in pediatric type 1 diabetic subjects.
RESEARCH DESIGN AND METHODS—Pediatric subjects were recruited if they had HbA1c >8.0% with management problems (n = 35) or episodes of severe or nocturnal hypoglycemia or hypoglycemia unawareness associated with HbA1c ≤8.0% (n = 12). A total of 47 patients with a mean HbA1c value of 8.6 ± 1.6% (mean age 11.8 ± 4.6 years, youngest 2.7 years, and diabetes duration 5.5 ± 3.5 years) on three to four insulin injections/day (n = 24) or insulin pump therapy (n = 23) were followed with the CGMS for a mean of 69.5 ± 28 h. Comparisons were made between the number of high (>150 mg/dl) and low (<70 mg/dl) glucose patterns discerned with the sensor or the logbook, and HbA1c levels were evaluated.
RESULTS—In patients on injection therapy, 30 high or low glucose patterns were discerned with the logbook records and 120 patterns with the CGMS. Specific alterations of the diabetes regimen were made. An overall significant change in HbA1c, from 3 months before wearing the sensor to 6 months after (analysis of variance 0.04), was found in the subjects. Post hoc analysis showed a significant change in HbA1c from 8.6 ± 1.5% at baseline to 8.4 ± 1.3% at 3 months (paired Student’s t test 0.03).
CONCLUSIONS—The CGMS can be used by pediatric patients to detect abnormal patterns of glycemia. The information that was obtained could be used to alter the diabetes regimen and impact glycemic outcome.
- ANOVA, analysis of variance
- CGMS, continuous glucose monitoring system
- CSII, continuous subcutaneous insulin infusion
Address correspondence and reprint requests to Francine R. Kaufman, 4650 Sunset Blvd, MS #61, Los Angeles, CA 90027. E-mail:.
Received for publication 27 December 2000 and accepted in revised form 17 August 2001.
F.R.C. has received consultantships from and served on advisory panels for Minimed, Integ, Novo Nordisk, Genentech, Medisense Ketone, Inverness, Johnson & Johnson, Takeda Pharmaceuticals, Cygnus, Ortho McNeil, and Amylin; is a stockholder in MiniMed and Clincal Products; has received grant/research support from Bristol Myers Squibb, Genentech, Pharmacia & Upjohn, Eli Lilly, Novo Nordisk, Pfizer, MiniMed, and Takeda Pharmaceuticals; and is on the the speaker’s bureau for Eli Lilly, Novo Nordisk, and MiniMed. M.H. is a stock shareholder in MiniMed and Inhale; has received honoraria for speaking engagements from MiniMed, Novo Nordisk, Lilly, and Medisense; and has received grant/research support from MiniMed, Lilly, Starbright, and NovoNordisk. S.C. is a stockholder in MiniMed.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.