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RESULTS

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Can be Vancouver style i.e. 1 Meyer J-P et al. The treatment of high grade superficial bladder cancer and carcinoma in situ with BCG – a questionnaire survey of Consultant practice in England and Wales. UrolOncol 2002; 2;: 77-80

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CONTACT INFORMATION Highlight this text and replace with your own text.

P o s t e r t i t l e g o e s h e r e Authors, FIRST NAME INITIAL, SURNAME, presenting author(s) underlined, Affiliations1 numbered in superscripte.g. B. SMITH 1, N. HARRISON 2 2 and P. MATTHEWS2

1University of New South Wales, Sydney, Australia2Royal Brisbane Hospital, Brisbane, Australia

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The accuracy and safety of the implantable Eversense CGM system over the 90-day sensor life was confirmed with an MARD of 9.6% over the glucose range of 40–400 mg/dL and 85% of CGM values within 15/15% of reference values. Accuracy was particularly strong in the hypoglycemic range with 92% of readings within 15/15% of reference values in the glucose range of 40 to 60 mg/dL. The median wear time observed in this trial was again 98% of the day (Figure 4). The favorable safety profile demonstrated in PRECISE II was corroborated in this study with no device- or procedure-related SAEs.

Discussion

The robust performance and favorable safety profile of the Eversense CGM system was verified in the PRECISION study which evaluated an unblinded system through 90 days. Of note, strong accuracy performance was attained in the hypoglycemic ranges.

ConclusionE�ectiveness parameters of MARD between paired Eversense and Yellow Springs Instrument (YSI) reference glucose measurements and percent of CGM system agreement within 15 mg/dL or 15% (15/15% metric) of YSI reference measurements through 90 days for reference glucose values from 40 to 400 mg/dL were evaluated. The incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days post-insertion was the primary safety endpoint.

Methods

A strong accuracy and safety profile of the new implantable Eversense CGM system in participants with type 1 or type 2 diabetes (T1D, T2D) was demonstrated in a prior multi-center, prospective, blinded study (PRECISE II). The objective of this study was to conduct a subsequent prospective, multi-center study (PRECISION) to assess overall performance and safety with an unblinded device with specific focus in the hypoglycemic range.

Objective Figure 1: Sensor performance in the 15/15% range

[%]

100806040200

[mg/dL]

15/15% metric

40-60 61-80 40-400

85%87%92%

Table 1: Demographic

Variable Value

18 (51.4)17 (48.6)51.6 (15.7)

4 (11.4)31 (88.6)

32 (91.4)1 (2.9)2 (5.7)

28.2 (5.4)26.0 (14.3)

25 (71.4)10 (28.6)

5 (14.3)11 (31.4)19 (54.3)

aParticipants with T2D

Gender, n (%) Male FemaleAge, years (SD)Ethnicity n (%) Hispanic Non-HispanicRace, n (%) Caucasian Black or African American AsianBMI, kg/m2 (SD)Years since diabetes diagnosis, years (SD)Diabetes type, n (%) Type 1 Type 2Type of diabetes therapy, n (%) Oral or diet and exercisea

Multiple daily insulin injections Continuous insulin infusion pump

Figure 2: Sensor performance at di�erent glucose levels

[mg/dL]

MARD [%]

[%]

40-400

121086420

9.6

[mg/

dL]

[mg/dL]

MAD [mg/dL]

40-60 61-80

121086420

7.2 7.6

Figure 3: HbA1c Figure 4: Wear Time %

HbA1c %

[%]

Baseline 90d

87.87.67.47.2

7

7.8

7.5Observed wear time

[%]

Wear time %

0 20 40 60 80 100

98%

Results

Thirty-five participants received the CGM system (Table 1). Eighty-five percent (85%) of CGM values were within 15/15% of reference values over the total glucose range of 40–400 mg/dL (Figure 1). Hypoglycemic ranges of 40-60 and 61-80 mg/dL demonstrated 92% and 87% within 15 mg/dL and MADs of 7.2 mg/dL and 7.6 mg/dL (Figure 1 and Figure 2), respectively. Overall MARD value against reference glucose values was 9.6% (95% CI: 8.9, 10.4) (Figure 2). There was an improvement of HbA1c observed during the course of the trial (Figure 3).

Hypoglycemia performance evaluation of a new implantable CGM system

Mark Christiansen, MD1; Timothy Bailey, MD2; Leslie Kla�, MD3, Ron Brazg, MD3, and Katherine S Tweden, PhD4

1Diablo Clinical Research Inc., Walnut Creek, CA, USA; 2AMCR Institute Inc., Escondido, CA, USA; 3Rainer Clinical Research Center Inc., Renton, WA, USA; 4Senseonics Inc. Germantown, MD, USA

CONTACT INFORMATION Senseonics, Inc. 20451 Seneca Meadows Parkway, Germantown, MD 20876 Phone: 844-SENSE4U (736-7348) Email: Katherine.Tweden@senseonics.com