Dataset Information

Feasibility of 10-day use of a continuous glucose-monitoring system in adults with type 1 diabetes.

ABSTRACT:

Objective

The purpose of this pilot study was to evaluate the feasibility of 10-day use of a transcutaneous, real-time, continuous glucose-monitoring (CGM) system. All previous reports using different CGM systems were for 3-, 5-, or 7-day use.

Research design and methods

On day 1, subjects received the CGM device (SEVEN System) and underwent training on proper use. Subjects returned to the clinic on days 2, 7, and 10 for in-clinic sessions. On days 2 and 7, half the subjects performed fingersticks every 15 min and the other half had Yellow Springs Instruments (YSI) samples drawn every 15 min. On day 10, all subjects participated in an 8-h in-clinic session with YSI and fingerstick testing.

Results

The median absolute relative difference for CGM versus YSI was 12.6, 11.3, and 14.5% on days 2, 7, and 10, respectively (P = 0.63). CGM performed better on day 10 when compared with self-monitoring of blood glucose as compared with YSI.

Conclusions

This is the first study to document 10-day use of a 7-day CGM system.

SUBMITTER: Garg SK

PROVIDER: S-EPMC2646024 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

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Publications

Feasibility of 10-day use of a continuous glucose-monitoring system in adults with type 1 diabetes.

Garg Satish K SK Voelmle Mary K MK Gottlieb Peter P

Diabetes care 20081125 3

<h4>Objective</h4>The purpose of this pilot study was to evaluate the feasibility of 10-day use of a transcutaneous, real-time, continuous glucose-monitoring (CGM) system. All previous reports using different CGM systems were for 3-, 5-, or 7-day use.<h4>Research design and methods</h4>On day 1, subjects received the CGM device (SEVEN System) and underwent training on proper use. Subjects returned to the clinic on days 2, 7, and 10 for in-clinic sessions. On days 2 and 7, half the subjects perfo ...[more]

PMID: 19033411

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Project description:BACKGROUND:Frequent use of continuous glucose monitoring (CGM) systems is associated with improved glycemic outcomes in persons with diabetes, but the need for calibrations and sensor insertions are often barriers to adoption. In this study, we evaluated the performance of G6, a sixth-generation, factory-calibrated CGM system specified for 10-day wear. METHODS:The study enrolled participants of ages 6 years and up with type 1 diabetes or insulin-treated type 2 diabetes at 11 sites in the United States. Participation involved one sensor wear period of up to 10 days. Adults wore the system on the abdomen; youth of ages 6-17 years could choose to wear it on the abdomen or upper buttocks. Clinic sessions for frequent comparison with reference blood glucose measurements took place on days 1, 4-5, 7, and/or 10. Participants of ages 13 years and up underwent purposeful supervised glucose manipulation during in-clinic sessions. During the study, participants calibrated the systems once daily. However, analysis was performed on glucose values that were derived from reprocessed raw sensor data, independently of self-monitored blood glucose values used for calibration. Reprocessing used assigned sensor codes and a factory-calibration algorithm. Performance evaluation included the proportion of CGM values that were within ±20% of reference glucose values >100?mg/dL or within ±20?mg/dL of reference glucose values ?100?mg/dL (%20/20), the analogous %15/15, and the mean absolute relative difference (MARD, expressed as a percentage) between temporally matched CGM and reference values. RESULTS:Data from 262 study participants (21,569 matched CGM reference pairs) were analyzed. The overall %15/15, %20/20, and MARD were 82.4%, 92.3%, and 10.0%, respectively. Matched pairs from 134 adults and 128 youth of ages 6-17 years were similar with respect to %20/20 (92.4% and 91.9%) and MARD (9.9% and 10.1%). Overall %20/20 values on days 1 and 10 of sensor wear were 88.6% and 90.6%, respectively. The system's "Urgent Low Soon" (predictive of hypoglycemia within 20?min) hypoglycemia alert was correctly provided 84% of the time within 30?min before impending biochemical hypoglycemia (<70?mg/dL). The 10-day sensor survival rate was 87%. CONCLUSION:The new factory-calibrated G6 real-time CGM system provides accurate readings for 10 days and removes several clinical barriers to broader CGM adoption.

Dataset Information

Feasibility of 10-day use of a continuous glucose-monitoring system in adults with type 1 diabetes.

Objective

Research design and methods

Results

Conclusions

Publications

Feasibility of 10-day use of a continuous glucose-monitoring system in adults with type 1 diabetes.

Similar Datasets

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