CoChat
Sign Up
Cited by 831Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes Management and Education

Continuous glucose monitoring and metrics for clinical trials: an international consensus statement

Open access
Battelino, Tadej, Alexander, Charles M, Amiel, Stephanie A, Arreaza-Rubin, Guillermo, Beck, Roy W, Bergenstal, Richard M, Buckingham, Bruce A, Carroll, James +28 more·2023·The Lancet Diabetes & Endocrinology
DOI 10.1016/s2213-8587(22)00319-9
Open this paper in CoChat — free account

Abstract

Randomised controlled trials and other prospective clinical studies for novel medical interventions in people with diabetes have traditionally reported HbA1c as the measure of average blood glucose levels for the 3 months preceding the HbA1c test date. The use of this measure highlights the long-established correlation between HbA1c and relative risk of diabetes complications; the change in the measure, before and after the therapeutic intervention, is used by regulators for the approval of medications for diabetes. However, with the increasing use of continuous glucose monitoring (CGM) in clinical practice, prospective clinical studies are also increasingly using CGM devices to collect data and evaluate glucose profiles among study participants, complementing HbA1c findings, and further assess the effects of therapeutic interventions on HbA1c. Data is collected by CGM devices at 1-5 min intervals, which obtains data on glycaemic excursions and periods of asymptomatic hypoglycaemia or hyperglycaemia (ie, details of glycaemic control that are not provided by HbA1c concentrations alone that are measured continuously and can be analysed in daily, weekly, or monthly timeframes). These CGM-derived metrics are the subject of standardised, internationally agreed reporting formats and should, therefore, be considered for use in all clinical studies in diabetes. The purpose of this consensus statement is to recommend the ways CGM data might be used in prospective clinical studies, either as a specified study endpoint or as supportive complementary glucose metrics, to provide clinical information that can be considered by investigators, regulators, companies, clinicians, and individuals with diabetes who are stakeholders in trial outcomes. In this consensus statement, we provide recommendations on how to optimise CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These recommendations have been endorsed by the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, DiabetesIndia, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. A standardised approach to CGM data collection and reporting in clinical trials will encourage the use of these metrics and enhance the interpretability of CGM data, which could provide useful information other than HbA1c for informing therapeutic and treatment decisions, particularly related to hypoglycaemia, postprandial hyperglycaemia, and glucose variability.

Integrity signals

Registry

Crossref · 10.1016/s2213-8587(22)00319-9

Cites

106 of 106 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

We couldn’t retrieve this paper’s full text, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The observed reduction in HbA1c did not compromise the population from meeting established hypoglycemia targets of <4% and <1% for percent time <70 mg/dL (mean 1.0%) and <54 mg/dL (mean 0.04%), respectively.

    “The observed reduction in HbA1c did not compromise the population from meeting established hypoglycemia targets of < 4% and < 1% for percent time < 70 mg/dL (mean 1.0%) and < 54 mg/dL (mean 0.04%), respectively (22-24).”

    From Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis (2025) · cites this paper as [22]

  • CGM helps characterize the timing, amplitude, and frequency of excursions, and provides quantitative metrics such as TIR, time in hypoglycemia (TBR) and hyperglycemia (TAR), and indices of glycemic variability, which are increasingly used as clinically meaningful targets in diabetes management.

    “CGM helps characterize the timing, amplitude, and frequency of excursions [133–139], and provides quantitative metrics such as TIR, time in hypoglycemia (TBR) and hyperglycemia (TAR), and indices of glycemic variability, which are increasingly used as clinically meaningful targets in diabetes management [140–144].”

    From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [140]

  • Glycaemic metrics were heterogeneous across included studies, with only a few studies using CGM metrics as recommended by international guidelines and often over a limited period of observation.

    “Third, glycaemic metrics were also heterogeneous, with only a few studies using CGM metrics as recommended by international guidelines [24] and often over a limited period of observation.”

    From Menstrual Cycle, Glucose Control and Insulin Sensitivity in Type 1 Diabetes: A Systematic Review (2023) · cites this paper as [24]

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Battelino, T., Alexander, C. M., Amiel, S. A., Arreaza-Rubin, G., Beck, R. W., Bergenstal, R. M., Buckingham, B. A., Carroll, J., Ceriello, A., Chow, E., Choudhary, P., Close, K., Danne, T., Dutta, S., Gabbay, R., Garg, S., Heverly, J., Hirsch, I. B., Kader, T., Kenney, J., Kovatchev, B., Laffel, L., Maahs, D., Mathieu, C., Mauricio, D., Nimri, R., Nishimura, R., Scharf, M., Del Prato, S., Renard, E., Rosenstock, J., Saboo, B., Ueki, K., Umpierrez, G. E., Weinzimer, S. A., & Phillip, M.
Affiliations
  • University of Ljubljana (SI)
  • King's College London (GB)
  • Jaeb Center for Health Research (US)
  • Park Nicollet Clinic (US)
  • Stanford Medicine (US)
  • MultiMedica (IT)
  • Chinese University of Hong Kong (HK)
  • University of Leicester (GB)
  • Close Concerns (United States) (US)
  • Kinderkrankenhaus auf der Bult (DE)
  • Breakthrough T1D (US)
  • American Diabetes Association (US)
  • University of Colorado Denver (US)
  • University of Washington (US)
  • Jewish General Hospital (CA)
  • University of Virginia (US)
  • Joslin Diabetes Center (US)
  • KU Leuven (BE)
  • Schneider Children's Medical Center (IL)
  • Jikei University School of Medicine (JP)
  • Hospital Nossa Senhora das Graças (BR)
  • The University of Texas Southwestern Medical Center (US)
  • Diabetes Care & Hormone Clinic (IN)
  • National Center for Global Health and Medicine (JP)
  • Emory University (US)
  • Yale University (US)
  • Tel Aviv University (IL)
Corresponding author
Battelino, Tadej
ORCID
Venue
The Lancet Diabetes & Endocrinology
Publisher
Elsevier BV
Published
2023-01
Volume
11
Issue
1
Pages
42-57
ISSN
2213-8587 (ISSN-L)
DOI
10.1016/s2213-8587(22)00319-9
OpenAlex
W4311596863
Semantic Scholar
2ffd8a88f1a939776f962b3dac60492f93b8953c
Cited by
831
References
106
Citations by year
2026: 248 · 2025: 264 · 2024: 215 · 2023: 102 · 2022: 2
FWCI
108.05
Type
journal article
Language
en
Update notices
erratum (2024-02-01)
Open access
Licence
Locations
  • The Lancet Diabetes & Endocrinology (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
  • Figshare (submittedVersion, cc-by)
  • Research Portal (King's College London) (submittedVersion)
  • Lirias (KU Leuven) (submittedVersion)
Funders
  • American Diabetes Association
  • European Medicines Agency
  • Juvenile Diabetes Research Foundation International
  • American Association of Clinical Endocrinologists
  • Agencija za raziskovalno dejavnost Republike Slovenije
  • European Association for the Study of Diabetes
  • Japan Diabetes Society
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
continuous glucose monitoring, HbA1c, glycemic control, hypoglycemia, postprandial hyperglycemia, glycemic variability, glycaemic excursions, clinical trial endpoints, international consensus
MeSH terms
Adolescent, Blood Glucose, Child, Clinical Trials as Topic, Diabetes Mellitus, Type 1, Humans, Hyperglycemia, Hypoglycemia, Prospective Studies, Blood Glucose Self-Monitoring

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review