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http://hdl.handle.net/1942/35804
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DC Field | Value | Language |
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dc.contributor.author | Visser, MM | - |
dc.contributor.author | Charleer, S | - |
dc.contributor.author | FIEUWS, Steffen | - |
dc.contributor.author | De Block, C | - |
dc.contributor.author | Hilbrands, R | - |
dc.contributor.author | Van Huffel, L | - |
dc.contributor.author | Maes, T | - |
dc.contributor.author | Vanhaverbeke, G | - |
dc.contributor.author | Dirinck, E | - |
dc.contributor.author | Myngheer, N | - |
dc.contributor.author | Vercammen, C | - |
dc.contributor.author | Nobels, F | - |
dc.contributor.author | Keymeulen, B | - |
dc.contributor.author | Mathieu, C | - |
dc.contributor.author | Gillard, P | - |
dc.date.accessioned | 2021-11-10T11:17:47Z | - |
dc.date.available | 2021-11-10T11:17:47Z | - |
dc.date.issued | 2021 | - |
dc.date.submitted | 2021-09-14T09:26:46Z | - |
dc.identifier.citation | The Lancet, 397 (10291) , p. 2275 -2283 | - |
dc.identifier.issn | 01406736 | - |
dc.identifier.uri | http://hdl.handle.net/1942/35804 | - |
dc.description.abstract | Background People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1).Methods We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA(1c)), time in range (sensor glucose 3.9-10.0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600.Findings Between Jan 29 and July 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59.6% vs 51.9%; mean difference 6.85 percentage points [95% CI 4.36-9.34]; p<0.0001). After 6 months HbA(1c) was lower (7.1% vs 7.4%; p<0.0001), as was time <3.0 mmol/L (0.47% vs 0.84%; p=0.0070), and Hypoglycaemia Fear Survey version II worry subscale score (15.4 vs 18.0; p=0.0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0.0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users.Interpretation In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes. Copyright (C) 2021 Elsevier Ltd. All rights reserved. | - |
dc.description.sponsorship | Acknowledgments University Hospitals Leuven, Leuven, Belguim (sponsor of the ALERTT1 trial) acted as sponsor and received a research grant from Dexcom (San Diego, CA, USA). Dexcom provided the experimental real-time continuous glucose monitoring device and technical support (to study teams only) in case of device issues. Representatives of Dexcom reviewed the manuscript, but had no role in study design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit for publication. The authors would like to thank the study nurses, the local investigators and their teams for monitoring the patients, completing the case reporting files, and collecting data. The authors wouldv like to especially thank the patients who participated in the trial | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.rights | 2021 Elsevier Ltd. All rights reserved. | - |
dc.subject.other | Adult | - |
dc.subject.other | Belgium | - |
dc.subject.other | Blood Glucose | - |
dc.subject.other | Diabetes Mellitus, Type 1 | - |
dc.subject.other | Female | - |
dc.subject.other | Glycated Hemoglobin | - |
dc.subject.other | Humans | - |
dc.subject.other | Hypoglycemia | - |
dc.subject.other | Hypoglycemic Agents | - |
dc.subject.other | Insulin | - |
dc.subject.other | Insulin Infusion Systems | - |
dc.subject.other | Male | - |
dc.subject.other | Prospective Studies | - |
dc.subject.other | Quality of Life | - |
dc.subject.other | Blood Glucose Self-Monitoring | - |
dc.title | Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 2283 | - |
dc.identifier.issue | 10291 | - |
dc.identifier.spage | 2275 | - |
dc.identifier.volume | 397 | - |
local.bibliographicCitation.jcat | A1 | - |
local.publisher.place | STE 800, 230 PARK AVE, NEW YORK, NY 10169 USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1016/s0140-6736(21)00789-3 | - |
dc.identifier.pmid | 34089660 | - |
dc.identifier.isi | 000660072500030 | - |
dc.identifier.eissn | 1474-547X | - |
local.provider.type | Web of Science | - |
local.uhasselt.international | yes | - |
item.accessRights | Restricted Access | - |
item.contributor | Visser, MM | - |
item.contributor | Charleer, S | - |
item.contributor | FIEUWS, Steffen | - |
item.contributor | De Block, C | - |
item.contributor | Hilbrands, R | - |
item.contributor | Van Huffel, L | - |
item.contributor | Maes, T | - |
item.contributor | Vanhaverbeke, G | - |
item.contributor | Dirinck, E | - |
item.contributor | Myngheer, N | - |
item.contributor | Vercammen, C | - |
item.contributor | Nobels, F | - |
item.contributor | Keymeulen, B | - |
item.contributor | Mathieu, C | - |
item.contributor | Gillard, P | - |
item.fullcitation | Visser, MM; Charleer, S; FIEUWS, Steffen; De Block, C; Hilbrands, R; Van Huffel, L; Maes, T; Vanhaverbeke, G; Dirinck, E; Myngheer, N; Vercammen, C; Nobels, F; Keymeulen, B; Mathieu, C & Gillard, P (2021) Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial. In: The Lancet, 397 (10291) , p. 2275 -2283. | - |
item.fulltext | With Fulltext | - |
item.validation | ecoom 2022 | - |
crisitem.journal.issn | 0140-6736 | - |
crisitem.journal.eissn | 1474-547X | - |
Appears in Collections: | Research publications |
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xx.pdf Restricted Access | Published version | 3.6 MB | Adobe PDF | View/Open Request a copy |
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