| Literature DB >> 30925083 |
Mark P Christiansen1, Leslie J Klaff2, Timothy S Bailey3, Ron Brazg2, Grace Carlson4, Katherine S Tweden5.
Abstract
Background: A prior study (PRECISE II) demonstrated that an implantable continuous glucose monitoring (CGM) system (Eversense® CGM System) provided accurate glucose readings through the 90-day sensor life with a favorable safety profile in participants with type 1 or type 2 diabetes (T1D, T2D). This study was performed to further characterize the accuracy of the system.Entities:
Keywords: Continuous glucose monitoring; Implantable; Type 1 diabetes; Type 2 diabetes; accuracy
Mesh:
Substances:
Year: 2019 PMID: 30925083 PMCID: PMC6532543 DOI: 10.1089/dia.2019.0020
Source DB: PubMed Journal: Diabetes Technol Ther ISSN: 1520-9156 Impact factor: 6.118
Baseline Participant Characteristics (n = 35)
| Gender, | |
| Male | 18 (51.4) |
| Female | 17 (48.6) |
| Age, years (SD) | 51.6 (15.7) |
| Ethnicity, | |
| Hispanic | 4 (11.4) |
| Non-Hispanic | 31 (88.6) |
| Race, | |
| Caucasian | 32 (91.4) |
| Black or African American | 1 (2.9) |
| Asian | 2 (5.7) |
| BMI, kg/m2 (SD) | 28.2 (5.4) |
| Years since diabetes diagnosis, years (SD) | 26.0 (14.3) |
| Diabetes type, | |
| Type 1 | 25 (71.4) |
| Type 2 | 10 (28.6) |
| Type of diabetes therapy, | |
| Oral or diet and exercise[ | 5 (14.3) |
| Multiple daily insulin injections | 11 (31.4) |
| Continuous insulin infusion pump | 19 (54.3) |
Participants with T2D.
SD, standard deviation; T2D, type 2 diabetes.
Continuous Glucose Monitoring System Accuracy and Stability by Clinic Visit
| Day 1 | 2665 | 79 | 89 | 96 | 99 | 11.6 |
| Day 7 | 2926 | 86 | 93 | 98 | 99 | 9.8 |
| Day 14 | 2997 | 88 | 95 | 99 | 100 | 9.0 |
| Day 30 | 2284 | 88 | 94 | 99 | 100 | 8.9 |
| Day 60 | 2133 | 87 | 94 | 99 | 100 | 8.7 |
| Day 90 | 2165 | 84 | 92 | 99 | 99 | 9.7 |
CGM, continuous glucose monitoring; MARD, mean absolute relative difference; YSI, Yellow Springs Instrument.
Continuous Glucose Monitoring System Accuracy Over Continuous Glucose Monitoring System Glucose Range
| Overall | 15,170 | 85 | 93 | 98 | 99 | 9.6 |
| 40–60 | 1236 | 92 | 96 | 98 | 99 | 7.2 |
| 61–80 | 2003 | 87 | 94 | 99 | 100 | 7.6 |
| 81–180 | 5786 | 81 | 90 | 97 | 99 | 10.5 |
| 181–300 | 3566 | 85 | 93 | 98 | 99 | 8.6 |
| 301–350 | 1628 | 93 | 98 | 99 | 100 | 6.9 |
| 351–400 | 951 | 92 | 96 | 99 | 100 | 6.4 |
Mean absolute difference (mg/dL) was calculated for glucose values ≤80 mg/dL.
In-Clinic Hypoglycemic and Hyperglycemic Event Detection Using Both Threshold and 10 min Predictive Alerts
| Hypoglycemic alert | ||||
| 60 | 89% | 11% | 77% | 23% |
| 70 | 95% | 5% | 92% | 8% |
| Hyperglycemic alert | ||||
| 180 | 99% | 1% | 93% | 7% |
| 240 | 99% | 1% | 94% | 6% |
Continuous Glucose Monitoring System Accuracy Over Continuous Glucose Monitoring System Glucose Range of PRECISE II
| Overall | 15,753 | 87 | 94 | 99 | 100 | 8.5 |
| 40–60 | 480 | 85 | 92 | 98 | 100 | 8.3 |
| 61–80 | 1111 | 83 | 91 | 97 | 99 | 8.7 |
| 81–180 | 7844 | 86 | 94 | 98 | 100 | 8.4 |
| 181–300 | 5377 | 88 | 96 | 99 | 100 | 7.8 |
| 301–350 | 692 | 91 | 98 | 100 | 100 | 7.0 |
| 351–400 | 249 | 97 | 99 | 100 | 100 | 5.2 |