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Clinical Trial
. 2011 Mar;34(3):574-9.
doi: 10.2337/dc10-1852. Epub 2011 Jan 28.

Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study

Satish K Garg  1 , Mary K Voelmle, Christie R Beatson, Hayley A Miller, Lauren B Crew, Brandon J Freson, Rachel M Hazenfield
Affiliations
Clinical Trial

Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study

Satish K Garg et al. Diabetes Care. 2011 Mar.

Abstract

Objective: To compare use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injection (MDI) therapy versus continuous subcutaneous insulin infusion (CSII) therapy for 6 months.

Research design and methods: Sixty type 1 diabetic adults with similar baseline characteristics, using either MDI (n = 30) or CSII (n = 30) therapy, were enrolled in this 6-month prospective study. Subjects were instructed to wear the DexCom SevenPLUS continuous glucose monitor at all times throughout the study. All subjects were initially blinded from the continuous glucose monitoring (CGM) glucose data. After 4 weeks of blinded CGM use, the CGM was unblinded, making glucose data available to the patient. The CGM remained in the unblinded state for the remainder of the study (20 weeks). Clinic visits occurred every 4 weeks, at which time A1C values were collected and CGM data were downloaded.

Results: Mean baseline (± SD) A1C was 7.61 (± 0.76) and 7.63 (± 0.68) for CSII and MDI, respectively (P > 0.05). Without any significant therapy change, A1C decrease at 12 weeks was similar in both groups (P = 0.03). When compared with the blinded phase, unblinded use of CGM was associated with similar but significant reductions in glycemic control and variability parameters. In addition, both therapy groups had similar changes in mean glucose and glucose variability indexes at 3 and 6 months (ITT analysis, P > 0.05). Predefined per protocol analysis (sensor use at least 6 days/week) showed greater improvement in time spent in target range glycemia, 3.9-10.0 mmol/L (70-180 mg/dL), in the CSII group.

Conclusions: We conclude that CGM provides similar benefits in glucose control for patients using MDI or CSII therapy.

Trial registration: ClinicalTrials.gov NCT01104142.

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Figures

Figure 1
Figure 1
Changes in hypoglycemic excursions during the study period were similar in ITT (n = 60) (A) and per-protocol analysis (n = 34) (B).
Figure 2
Figure 2
Changes in hyperglycemic excursions during the study period were also similar in the ITT analysis (n = 60) (A). However, hyperglycemic excursions were significantly lower in the CSII group in the subgroup analysis (per-protocol analysis, n = 34, B).
See this image and copyright information in PMC

References

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