Format

Send to

Choose Destination
Diabetes Technol Ther. 2017 Jul;19(7):391-399. doi: 10.1089/dia.2017.0054. Epub 2017 May 22.

Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.

Author information

1
1 Forschergruppe Diabetes e.V., Helmholtz Zentrum, Munich , Germany .
2
2 Bournemouth University , Faculty of Health and Social Science, Bournemouth, United Kingdom .
3
3 International Diabetes Center , Minneapolis, Minnesota.
4
4 Vita-Salute San Raffaele University , Department of General Medicine-Diabetes & Endocrinology Unit, Milan, Italy .
5
5 Barbara Davis Center for Diabetes, University of Colorado Denver , Denver, Colorado.
6
6 Centre Hospitalier Universitaire Nancy , Vandoeuvre-Les-Nancy, France .
7
7 Diabetes Center Mergentheim , Bad Mergentheim, Germany .
8
8 University of Washington School of Medicine , Division of Metabolism, Endocrinology and Nutrition, Seattle, Washington.
9
9 Department of Endocrinology and Metabolism, Peking University People's Hospital , Peking, China .
10
10 Indian Academy of Diabetes , Ahmedabad, India .
11
11 Queensland University of Technology , Faculty of Health, Brisbane, Australia .
12
12 Joslin Diabetes Center , Section on Pediatric, Adolescent and Young Adult Diabetes, Boston, Massachusetts.
13
13 University Hospital Gasthuisberg Leuven , Department of Clinical and Experimental Medicine, Leuven, Belgium .
14
14 Behavioral Diabetes Institute, University of California , San Diego, San Diego, California.
15
15 Department of Medical Psychology, VU University Medical Center and Academic Medical Center , Amsterdam, The Netherlands .
16
16 Institute of Cellular Medicine - Diabetes, Newcastle University , Newcastle upon Tyne, United Kingdom .

Abstract

Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.

KEYWORDS:

CGM; Clinical trials; Recommendation

PMID:
28530490
PMCID:
PMC5695750
DOI:
10.1089/dia.2017.0054
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center