Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus: Comparative Effectiveness
Glucose Monitoring With rt-CGM Versus SMBG in Children and Adults With Type 1 Diabetes
All included studies comparing rt-CGM with SMBG were in children and adults with type 1 diabetes. No studies in patients with type 2 diabetes or pregnant women with pre-existing diabetes met the inclusion criteria.
There was high strength of evidence that rt-CGM had a significantly greater HbA1c- lowering effect when compared with SMBG in children and adults with type 1 diabetes.
- A meta-analysis of seven trials (nine estimates) of at least 12 weeks’ duration showed a significant difference in HbA1c between the rt-CGM and SMBG groups that favored rt-CGM (combined mean between-group difference from baseline, -0.30%; 95% CI, -0.37 to -0.22%; p < 0.001). In the meta-regression, sensor compliance was significantly associated with the degree of HbA1c reduction (r = -0.8258; p = 0.0221). In the sensitivity analysis that only included studies with more than a 60-percent rate of compliance with the sensor use (seven estimates), rt-CGM had an even greater effect on reducing HbA1c when compared with SMBG (combined mean between-group difference from baseline, -0.36%; 95% CI, -0.44 to -0.27%).
There was no significant difference in time spent in the hypoglycemic range with rt-CGM when compared with SMBG. The strength of evidence was moderate for this finding.
- A meta-analysis of four studies (six estimates) showed no difference between the rt-CGM and SMBG groups in time spent in the hypoglycemic range, defined as a glucose level <70 mg/dL. The mean between-group difference was -2.11 minutes/day (95% CI, -5.66 to 1.44 minutes/day).
Time spent in the hyperglycemic range was significantly reduced with rt-CGM when compared with SMBG. The strength of the evidence was rated moderate for this finding.
- A meta-analysis of four studies (six estimates) indicated a significant reduction in time spent in the hyperglycemic range, defined as a glucose level >180 mg/dL, with the mean between-group difference of -68.56 minutes/day favoring rt-CGM (95% CI, -101.17 to -35.96).
The evidence is inconsistent for the effect of rt-CGM versus SMBG on the ratio of basal to bolus insulin in a daily insulin dose in this population. The strength of evidence was rated low for this finding.
- One study reported that the basal rate was a higher proportion of the total daily insulin dose in the rt-CGM intervention groups when compared with the SMBG intervention group (mean between-group difference in final basal rate, 4.3%; 95% CI, 0.8 to 7.8%). In contrast, a second study reported a higher percentage of insulin delivered as bolus in the rt-CGM group when compared with the SMBG group (mean between-group difference in final percentage of insulin delivered as bolus, -4.0%; 95% CI, -9.3 to 1.3%).
No significant difference was found between the rt-CGM and SMBG groups in the rate of severe hypoglycemia, general quality of life, and diabetes-specific quality of life. The strength of evidence was rated low for this finding.
- A meta-analysis of six studies (eight separate study populations) that reported on severe hypoglycemia suggested a pooled RR of 0.95 (95% CI, 0.53 to 1.69; p = 0.86).
- One study assessed the well-being of the patients’ mothers with the World Health Organization-5 assessment tool and found no difference in parental satisfaction between the two intervention arms. The other study assessed general quality of life with the Short Form-12 and found an improvement on the Physical Component Score favoring rt-CGM, but no difference was found between the intervention arms on the Mental Component Score.
- Two studies examined diabetes-specific quality of life—one with the Problem Area in Diabetes tool in children and adolescents and one with the Diabetes Quality of Life Questionnaire in adults. There was no difference in diabetes-specific quality of life between the two intervention arms in either study.
Abbreviations: 95% CI = 95-percent confidence interval; HbA1c = hemoglobin A1c; RR = relative risk; rt-CGM = real-time continuous glucose monitoring; SMBG = self-monitoring of blood glucose
Keywords: adults | children | glucose monitoring | outcomes | rt-CGM | SMBG | strength of evidence | diabetes
- Golden SH, Brown T, Yeh HC, et al. Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus: Comparative Effectiveness. Comparative Effectiveness Review No. 57 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2007-10061-I). Rockville, MD: Agency for Healthcare Research and Quality; July 2012. AHRQ Publication No. 12-EHC036. Available at www.effectivehealthcare.ahrq.gov/glucose.cfm.
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