Accuracy and longevity of an implantable continuous glucose sensor in the PRECISE study: A 180-day, prospective, multicenter, pivotal trial

Diabetes Care

Volumn 40, Issue 1, 2017, Pages 63-68

  Kropff, Jort ^a   Choudhary, Pratik ^b   Neupane, Sankalpa ^c   Barnard, Katharine ^d   Bain, Steve C ^e   Kapitza, Christoph ^f   Forst, Thomas ^g   Link, Manuela ^h   Dehennis, Andrew ⁱ   De Vries, J Hans ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b KING'S COLLEGE LONDON   (United Kingdom)

^c CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^d BOURNEMOUTH UNIVERSITY   (United Kingdom)

^e SWANSEA UNIVERSITY   (United Kingdom)

^f Profil   (Germany)

^g Profil Mainz   (Germany)

^h UNIVERSITY OF ULM   (Germany)

ⁱ Senseonics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; DEVICE SAFETY; FEMALE; GLUCOSE SENSOR; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; MEASUREMENT ACCURACY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT MONITORING; PROSPECTIVE STUDY; REFERENCE VALUE; SELF MONITORING; ANALYSIS; BLOOD; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL; COMPLICATION; DEVICES; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; GLUCOSE BLOOD LEVEL; IMPLANTABLE INFUSION PUMP; INSULIN INFUSION; LONGEVITY; MIDDLE AGED; PROCEDURES; REPRODUCIBILITY;

ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL;

ADULT; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; FEMALE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INFUSION PUMPS, IMPLANTABLE; INSULIN INFUSION SYSTEMS; LONGEVITY; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS;

EID: 85008234027     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc16-1525     Document Type: Article

References (14)

1. Miller KM, Beck RW, Bergenstal RM, et al.; T1D Exchange Clinic Network. Evidence of a strong association between frequency of selfmonitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care 2013;36:2009-2014
2. Kovatchev BP, Patek SD, Ortiz EA, Breton MD. Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring. Diabetes Technol Ther 2015;17:177-186
3. Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ 2011;343:d3805
4. Rodbard D. Continuous glucose monitoring: A review of successes, challenges, and opportunities. Diabetes Technol Ther 2016;18(Suppl. 2): S23-S213
5. Englert K, Ruedy K, Coffey J, Caswell K, Steffen A, Levandoski L; Diabetes Research in Children (DirecNet) Study Group. Skin and adhesive issueswith continuous glucose monitors: A sticky situation. J Diabetes Sci Technol 2014;8: 745-751
6. Damiano ER, McKeon K, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A comparative effectiveness analysis of three continuous glucose monitors: The Navigator, G4 Platinum, and Enlite. J Diabetes Sci Technol 2014;8:699-708
7. Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol 2015;9:209-214
8. Kropff J, Bruttomesso D, Doll W, et al. Accuracy of two continuous glucose monitoring systems: A head-to-head comparison under clinical research centre and daily life conditions. Diabetes Obes Metab 2015;17:343-349
9. Taylor RL, Grebe SK, Singh RJ. Quantitative, highly sensitive liquid chromatography-tandem mass spectrometry method for detection of synthetic corticosteroids. Clin Chem 2004;50: 2345-2352
10. International Organization for Standardization. In vitro diagnostic test systems-requirements for blood glucose monitoring systems for selftesting in managing diabetes mellitus. Geneva, International Organization for Standardization, 2003, 15197:2013
11. Thabit H, Leelarathna L, Wilinska ME, et al. Accuracy of continuous glucose monitoring during three closed-loop home studies under free-living conditions. Diabetes Technol Ther 2015;17:801-807
12. Luijf YM,Mader JK, DollW, et al.; AP@home consortium. Accuracy and reliability of continuous glucose monitoring systems: A head-to-head comparison. Diabetes Technol Ther 2013;15: 722-727
13. Garg SK, Schwartz S, Edelman SV. Improved glucose excursions using an implantable realtime continuous glucose sensor in adults with type 1 diabetes. Diabetes Care 2004;27:734-738
14. Gough DA, Kumosa LS, Routh TL, Lin JT, Lucisano JY. Function of an implanted tissue glucose sensor for more than 1 year in animals. Sci Transl Med 2010;2:42ra53