Original ArticleUse of the Continuous Glucose Monitoring System to Guide Therapy in Patients With Insulin-Treated Diabetes: A Randomized Controlled Trial
Section snippets
PATIENTS AND METHODS
Patients 19 to 76 years of age were recruited prospectively from 7 diabetes centers in the United States from January to September 2000. All patients had insulin-treated diabetes and inadequate metabolic control at enrollment as shown by hemoglobin A1c values higher than 7.9%.
RESULTS
A total of 128 patients were recruited into the study (62 in the CGMS group and 66 in the SMBG group). Nineteen patients (14.8%) discontinued participation in the study, 11 in the CGMS group and 8 in the SMBG group (Figure 1). There were no significant differences between the demographic and baseline characteristics of patients in the CGMS group vs patients in the SMBG group (Table 1). Sensitivity analysis of the remaining 51 patients in the CGMS group and 58 patients in the SMBG group provided
DISCUSSION
Hypoglycemia is the most common adverse event associated with intensive therapy,1 with the risk of severe hypoglycemia increasing as hemoglobin A1c values decrease.15 Consequently, many people with insulin-treated diabetes maintain hemoglobin A1c values above recommended thresholds to reduce their risk of severe hypoglycemic events.16 Sensor downloads have previously revealed undetected hypoglycemia,4 and in the current study, similar findings in the CGMS group may have led investigators to
CONCLUSION
The CGMS-guided therapy adjustments can be used to improve glycemic control in patients with insulin-treated diabetes without increasing the risk of hypoglycemia compared with therapy adjustments based on SMBG values alone. These findings are well supported3, 5, 6, 7, 8, 11 and suggest that a 3-day retrospective review of glucose values may help health care providers make guided changes to the diabetes management plan that result in improved hemoglobin A1c values with reductions in hypoglycemia.
Acknowledgments
We thank the following individuals for collection, reporting, and quality control of the study data: Melissa Comerio, RN, Evelyne Fleury-Milfort, MSN, Angie Gaumond, RN, Mindy Saenz, RD, Lauren Somma, RN, Kelly McCulloch, MA, and Laurie Want, MSN. We are also indebted to Carla Rother, MS, Anna ter Veer, MS, and Lilly Jeng, MS, for statistical analysis and to Rebecca de León, MS, for preparation of the submitted manuscript.
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Clinical impact of CGM use
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2017, Journal of Diabetes and its ComplicationsCitation Excerpt :Hypoglycemia is one of the major barriers to more intensive management in patients with both T1D and T2D. There have been several CGM studies using professional CGM that were specifically designed to document the presence of hypoglycemia in adults with T2D diabetes (Gehlaut, Dogbey, Schwartz, Marling, & Shubrook, 2015; Kim et al., 2014; Munshi et al., 2011; Tanenberg et al., 2004). In the largest and most recent of these studies, Gehlaut et al. (2015) observed that almost half of the patients had mild or severe hypoglycemia and 75% of those episodes were asymptomatic.
This study was sponsored by Medtronic MiniMed, Northridge, Calif.
Drs Tanenberg and Bode have received funds from Medtronic MiniMed to conduct studies on devices that improve diabetes therapy and have consultancies with Medtronic MiniMed. Dr Bode is also a member of the Medical Board of Medtronic MiniMed. Drs Gross and Mastrototaro are employed by Medtronic MiniMed and hold stock in Medtronic MiniMed.
Presented in abstract form as a poster at the 63rd Scientific Sessions of the American Diabetes Association, New Orleans, La, June 13-17, 2003, and orally at the 18th Congress of the International Diabetes Federation, Paris, France, August 28, 2003.