دورية أكاديمية
Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial
| العنوان: | Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial |
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| المؤلفون: | 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 |
| المساهمون: | 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 |
| بيانات النشر: | ELSEVIER SCIENCE INC |
| سنة النشر: | 2021 |
| المجموعة: | Document Server@UHasselt (Universiteit Hasselt) |
| مصطلحات موضوعية: | Adult, Belgium, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Prospective Studies, Quality of Life, Blood Glucose Self-Monitoring |
| الوصف: | 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, ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 01406736 1474-547X |
| العلاقة: | The Lancet, 397 (10291) , p. 2275 -2283; http://hdl.handle.net/1942/35804Test; 2283; 10291; 2275; 397; 000660072500030 |
| DOI: | 10.1016/s0140-6736(21)00789-3 |
| الإتاحة: | https://doi.org/10.1016/s0140-6736Test(21)00789-3 http://hdl.handle.net/1942/35804Test |
| رقم الانضمام: | edsbas.78F4D58A |
| قاعدة البيانات: | BASE |
| تدمد: | 01406736 1474547X |
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| DOI: | 10.1016/s0140-6736(21)00789-3 |