Dataset Information

Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.

ABSTRACT:

Aims/introduction

The present study aimed to investigate the performance of a new real-time continuous glucose monitoring system.

Materials and methods

Interstitial glucose levels were monitored for 7 days in 63 patients with type 1 or type 2 diabetes using the Medtrum A6 TouchCare^® CGM System. Venous blood was collected on a randomized day of the wear period. Plasma glucose levels were measured as reference values.

Results

Among 1,678 paired sensor-reference values, 90.5% (95% confidence interval 89.1-91.9%) were within ±20%/20 mg/dL of the reference values, with a mean absolute relative difference of 9.1 ± 8.7% (95% CI: 8.9-9.2%). The percentages of paired sensor-reference values falling within zone A and B of the Clarke error grid analysis (EGA) and the type 1 diabetes consensus EGA were 99.1 and 99.8%. Continuous EGA showed that the percentages of accurate readings, benign errors, and erroneous readings were 89.9, 6.3 and 3.8%, respectively. Surveillance EGA showed that 90.6, 9.2, and 0.2% of sensor-reference values with no, slight and lower moderate risk, respectively. The mean absolute relative difference was 16.6, and 96.0% of the sensor values fell within zones A and B of the consensus EGA for hypoglycemia. More than 85% of sensor values were within ±20%/20 mg/dL of reference values, the mean absolute relative difference was <11, and >99.5% of the sensor values fell in zones A and B of the consensus EGA.

Conclusions

The Medtrum real-time continuous glucose monitoring system was numerically and clinically accurate over a large glucose range across 7 days of wear.

SUBMITTER: Zhou J

PROVIDER: S-EPMC5835467 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Publications

Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.

Zhou Jian J Zhang Shuo S Li Liang L Wang Yufei Y Lu Wei W Sheng Chunjun C Li Yiming Y Bao Yuqian Y Jia Weiping W

Journal of diabetes investigation 20170707 2

<h4>Aims/introduction</h4>The present study aimed to investigate the performance of a new real-time continuous glucose monitoring system.<h4>Materials and methods</h4>Interstitial glucose levels were monitored for 7 days in 63 patients with type 1 or type 2 diabetes using the Medtrum A6 TouchCare<sup>®</sup> CGM System. Venous blood was collected on a randomized day of the wear period. Plasma glucose levels were measured as reference values.<h4>Results</h4>Among 1,678 paired sensor-reference val ...[more]

PMID: 28563974

Similar Datasets

Project description:IntroductionOptimising patient adherence to prescribed lifestyle interventions to achieve improved blood glucose control remains a challenge. Combined use of real-time continuous glucose monitoring systems (RT-CGM) may promote improved glycaemic control. This pilot study examines the effects of a prescriptive lifestyle modification programme when combined with RT-CGM on blood glucose control and cardiovascular disease risk markers.MethodsTwenty adults (10 men, 10 women) with obesity and type-2 diabetes (T2D) (age 60.55 ± 8.38 years, BMI 34.22 ± 4.67 kg/m2) were randomised to a prescriptive low-carbohydrate diet and lifestyle plan whilst continuously wearing either an RT-CGM or an 'offline-blinded' monitor (control) for 12 weeks. Outcomes were glycaemic control (HbA1c, fasting glucose, glycaemic variability [GV]), diabetes medication (MeS), weight, blood pressure and lipids assessed pre- and post-intervention.ResultsBoth groups experienced reductions in body weight (RT-CGM - 7.4 ± 4.5 kg vs. control - 5.5 ± 4.0 kg), HbA1c (- 0.67 ± 0.82% vs. - 0.68 ± 0.74%), fasting blood glucose (- 1.2 ± 1.9 mmol/L vs. - 1.0 ± 2.2 mmol/L), LDL-C (- 0.07 ± 0.34 mmol/L vs. - 0.26 ± 0.42 mmol/L) and triglycerides (- 0.32 ± 0.46 mmol/L vs. - 0.36 ± 0.53 mmol/L); with no differential effect between groups (P ≥ 0.10). At week 12, GV indices were consistently lower by at least sixfold in RT-CGM compared to control (CONGA-1 - 0.27 ± 0.36 mmol/L vs. 0.06 ± 0.19 mmol/L; CONGA-2 - 0.36 ± 0.54 mmol/L vs. 0.05 ± 2.88 mmol/L; CONGA-4 - 0.44 ± 0.67 mmol/L vs. - 0.02 ± 0.42 mmol/L; CONGA-8 - 0.36 ± 0.61 vs. 0.02 ± 0.52 mmol/L; MAGE - 0.69 ± 1.14 vs. - 0.09 ± 0.08 mmol/L, although there was insufficient power to achieve statistical significance (P ≥ 0.11). Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).ConclusionThis study provides preliminary evidence that RT-CGM may be an effective strategy to optimise glucose control whilst following a low-carbohydrate lifestyle programme that targets improved glycaemic control, with minimal professional support.Trial registrationAustralian New Zealand Clinical Trials Registry identifier, ANZTR: 372898.FundingGrant funding was received for the delivery of the clinical trial only, by the Diabetes Australia Research Trust (DART).

Dataset Information

Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.

Aims/introduction

Materials and methods

Results

Conclusions

Publications

Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.

Similar Datasets

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