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Diabetes Obes Metab. 2020 Feb 9. doi: 10.1111/dom.13993. [Epub ahead of print]

Clinical Use of a 180-Day Implantable Glucose Sensor Improves Glycated Hemoglobin and Time in Range in Patients with Type 1 Diabetes.

Author information

1
Department of Health Science, University Magna Graecia, Catanzaro, Italy.
2
Department of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.
3
Diabetologia ed Endocrinologia ASL CN2 Alba Bra, Italy.
4
SSD di Diabetologia, AAS2 Bassa Friulana-Isontina, Italy.
5
UOSA Diabetologia, Fondazione IRCCS, University Agostino Gemelli, Rome, Italy.
6
Medicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro".
7
UOSD Diabetologia ed Endocrinologia ASP Potenza, Italy.
8
Clinica Medica I, Fondazione IRCCS, University San Matteo, Pavia, Italy.
9
Senseonics Inc., Germantown, Maryland, United States of America.

Abstract

AIMS:

This real-world study evaluated the changes in HbA1c and CGM metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes.

MATERIALS AND METHODS:

This was a prospective, multi-center, observational study among adult participants aged 18 years or older with type 1 diabetes across 7 diabetes-care centers in Italy who were inserted with Eversense for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range (TIR [glucose 70-180 mg/dL]), time above range (TAR [glucose >180 mg/dL]), time below range (TBR [glucose <70 mg/dL]), and glycemic variability were also assessed. Data were also analyzed by prior CGM use and by mode of insulin delivery.

RESULTS:

One-hundred patients were enrolled (mean age 36±12 years, mean baseline HbA1c 7.4±0.92% [57±10 mmol/mol]). Fifty-six percent of patients were continuous subcutaneous insulin infusion (CSII) pump users and 45% were prior CGM users. HbA1c significantly decreased in patients after 180 days of sensor wear (-0.43±0.69%, 5±8mmol/mol, p<0.0001). As expected, CGM-naïve patients achieved the greatest reduction in HbA1c (-0.74±0.48%, 8±5mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.

CONCLUSIONS:

Real-world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with Type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156). This article is protected by copyright. All rights reserved.

PMID:
32037699
DOI:
10.1111/dom.13993

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