Incremental Value of Continuous Glucose Monitoring When Starting Pump Therapy in Patients With Poorly Controlled Type 1 Diabetes

Abstract

OBJECTIVETo compare the improvements in glycemic control associated with transitioning to insulin pump therapy in patients using continuous glucose monitoring versus standard blood glucose self-monitoring.RESEARCH DESIGN AND METHODSThe RealTrend study was a 6-month, randomized, parallel-group, two-arm, open-label study of 132 adults and children with uncontrolled type 1 diabetes (A1C ≥8%) being treated with multiple daily injections. One group was fitted with the Medtronic MiniMed Paradigm REAL-Time system (PRT group), an insulin pump with integrated continuous subcutaneous glucose monitoring (CGM) capability, with instructions to wear CGM sensors at least 70% of the time. Conventional insulin pump therapy was initiated in the other group (continuous subcutaneous insulin infusion [CSII] group). Outcome measures included A1C and glycemic variability.RESULTSA total of 115 patients completed the study. Between baseline and trial end, A1C improved significantly in both groups (PRT group −0.81 ± 1.09%, P < 0.001; CSII group −0.57 ± 0.94%, P < 0.001), with no significant difference between groups. When the 91 patients who were fully protocol-compliant (including CGM sensor wear ≥70% of the time) were considered, A1C improvement was significantly greater in the PRT group (P = 0.004) (PRT group −0.96 ± 0.93%, P < 0.001; CSII group −0.55 ± 0.93%, P < 0.001). Hyperglycemia parameters decreased in line with improvements in A1C with no impact on hypoglycemia.CONCLUSIONSCGM-enabled insulin pump therapy improves glycemia more than conventional pump therapy during the first 6 months of pump use in patients who wear CGM sensors at least 70% of the time.

MANAGEMENT OF ENDOCRINE DISEASE: Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials

“…Minor hypoglycemia, defined as glucose level below 3.89 mmol/l (70 mg%), was presented in five studies in two ways: as a number of episodes and as time spent in hypoglycemia (12,13,14,15,18). In one of them, authors did not find any difference in hypoglycemic episodes between patients using RT-CGM and control groups (13).…”

“…In one of them, authors did not find any difference in hypoglycemic episodes between patients using RT-CGM and control groups (13). There was no significant reduction in time spent in hypoglycemia in RT-CGM subjects, compared with that in SBGM group (12,14,15,18).…”

“…Moreover, patients treated with insulin pump combined with RT-CGM had a lower HbA1c level (four RCTs, nZ497; MD K0.26; 95% CI: from K0.43 to K0.10; PZ0.002) compared with subjects managed with conventional insulin pump combined with SBGM (Fig. 3) There was a significant inverse correlation between the HbA1c level and the frequency of sensor use (13,14,16,18). In the JDRF study (12), RT-CGM effectively lowered HbA1c only in adults aged R25 years.…”

“…Table 1 summarizes the characteristics of the included trials. In five studies, insulin pump therapy was used in both experimental and control groups (13,14,16,17,18); in the next two studies, the number of patients treated with CSII or MDI was comparable for the experimental and control groups (12,15). All trials included in the review, except one (17), were multicentered.…”

“…We identified 38 articles that underwent further analysis. Finally, we included seven RCTs (nZ948) to both qualitative and quantitative analyses (12,13,14,15,16,17,18). Table 1 summarizes the characteristics of the included trials.…”