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Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.

Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial.

Author information

1
Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany. haak@diabetes-zentrum.de.
2
Department of Diabetology, Metabolic Diseases, and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.
3
Leeds Institute of Cardiovascular and Metabolic Medicine, The LIGHT Laboratories, University of Leeds, Leeds, West Yorkshire, UK.
4
Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany.
5
Department of Diabetes and Endocrinology, Assistance Publique-Hôpitaux de Paris, DHU FIRE, Lariboisière Hospital, University Paris-Diderot Paris-7, Paris, France.
6
The Diabetes Centre, Ipswich Hospital NHS Trust, Ipswich, Suffolk, UK.

Abstract

INTRODUCTION:

Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG).

METHODS:

This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction.

RESULTS:

Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: -3.1 ± 0.75 mmol/mol, [-0.29 ± 0.07% (mean ± SE)] and -3.4 ± 1.04 mmol/mol (-0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [-5.7 ± 0.96 mmol/mol (-0.53 ± 0.09%) and -2.2 ± 1.31 mmol/mol (-0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild).

CONCLUSION:

Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT02082184.

FUNDING:

Abbott Diabetes Care.

KEYWORDS:

Flash sensor glucose technology; Glucose monitoring; Insulin; Type 2 diabetes

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