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Outcome measures for artificial pancreas clinical trials: a consensus report

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Maahs, David M., Buckingham, Bruce A., Castle, Jessica R., Cinar, Ali, Damiano, Edward R., Dassau, Eyal, DeVries, J. Hans, Doyle, Francis J. +16 more·2016·Diabetes Care
DOI 10.2337/dc15-2716PMC PMC4915553
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Abstract

Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.

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  • The findings support the recent consensus conference recommendation that sensor glucose values <54 mg/dL represent a more meaningful cut-off than 70 mg/dL to define clinically important hypoglycemia.

    “Our findings support the recent consensus conference recommendation (12, 13) that sensor glucose values ,54 mg/dL represent a more meaningful cut-off than 70 mg/dL to define clinically important hypoglycemia because CGM glucose levels below 54 mg/dL were uncommon, whereas most participants had some glucose levels of 55 to 69 mg/dL.”

    From Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study (2019) · cites this paper as [13]

    In Additional Recommendations and Limitations (page unavailable), the consensus report suggests reporting CGM excursions below either 70 or 55 mg/dL as possible measures of hypoglycemia. It does not recommend a cutoff below 54 mg/dL or say that cutoff is more clinically meaningful than 70 mg/dL. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • Current consensus conferences have somewhat arbitrarily set time in ranges for CGM sensor glucose levels for patients with T1D, with time in target identified as being between 70 to 180 mg/dL.

    “The current consensus conferences have somewhat arbitrarily set time in ranges for CGM sensor glucose levels for patients with T1D, with time in target identified as being between 70 to 180 mg/dL (12,13).”

    From Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study (2019) · cites this paper as [13]

    The Objective and Rationale section advocates standardized CGM glucose metrics for artificial-pancreas studies and says they are broadly applicable to type 1 diabetes studies. Additional Recommendations and Limitations mentions arbitrary glycemic ranges, but the retrieved passages do not identify 70–180 mg/dL as the target range or say that consensus conferences set that range somewhat arbitrarily. Page numbers were not available in our copy. (LLM, conf=0.80)

    Experimental — accuracy not yet measured

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Authors
Maahs, D. M., Buckingham, B. A., Castle, J. R., Cinar, A., Damiano, E. R., Dassau, E., DeVries, J. H., Doyle, F. J., Griffen, S. C., Haidar, A., Heinemann, L., Hovorka, R., Jones, T. W., Kollman, C., Kovatchev, B., Levy, B. L., Nimri, R., O’Neal, D. N., Philip, M., Renard, E., Russell, S. J., Weinzimer, S. A., Zisser, H., & Lum, J. W.
Affiliations
  • University of Colorado Anschutz (US)
  • Stanford Medicine (US)
  • Oregon Health & Science University (US)
  • Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago, IL
  • Boston University (US)
  • Harvard University (US)
  • Amsterdam UMC Location University of Amsterdam (NL)
  • Breakthrough T1D (US)
  • McGill University (CA)
  • Profil Institute for Metabolic Research (DE)
  • University of Cambridge (GB)
  • The Kids Research Institute Australia (AU)
  • Jaeb Center for Health Research (US)
  • University of Virginia (US)
  • Johnson & Johnson (United States) (US)
  • Tel Aviv University (IL)
  • Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
  • Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel
  • Department of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Centre 1411, Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France
  • Yale University (US)
  • University of California, Santa Barbara (US)
Corresponding author
Lum, John W.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2016-03-20
Volume
39
Issue
7
Pages
1175-1179
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc15-2716
PMC
PMC4915553
OpenAlex
W2469701129
Cited by
211
References
6
Citations by year
2025: 6 · 2024: 10 · 2023: 17 · 2022: 21 · 2021: 23 · 2020: 16 · 2019: 31 · 2018: 47 · 2017: 34 · 2016: 6
FWCI
39.54
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • UWA Profiles and Research Repository (UWA) (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • HAL (submittedVersion)
  • Minerva Access (University of Melbourne) (submittedVersion)
  • Apollo (University of Cambridge) (submittedVersion)
  • Apollo
Funders
  • National Institutes of Health (UL1TR001863)
  • National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK101077)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
artificial pancreas, type 1 diabetes, outcome measures, continuous glucose monitoring, HbA1c, clinical trial reporting, consensus, glycemic control
MeSH terms
Blood Glucose, Clinical Trials as Topic, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Outcome Assessment, Health Care, Pancreas, Artificial, Consensus

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