Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial
BackgroundContinuous glucose monitoring (CGM) improves glycemic control and quality of life. Data on glycemic indices and fear of hypoglycemia (FoH) in newly diagnosed T1DM patients are limited.AimTo assess the impact of initiating intermittently scanned CGM (isCGM) within 1–6 months of diagnosis on...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fendo.2024.1503891/full |
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| author | Jerzy Hohendorff Jerzy Hohendorff Agata Grzelka-Wozniak Marta Wrobel Michal Kania Michal Kania Lidia Lapinska Dominika Rokicka Dorota Stoltny Irina Kowalska Krzysztof Strojek Dorota Zozulinska-Ziolkiewicz Maciej T. Malecki Maciej T. Malecki |
| author_facet | Jerzy Hohendorff Jerzy Hohendorff Agata Grzelka-Wozniak Marta Wrobel Michal Kania Michal Kania Lidia Lapinska Dominika Rokicka Dorota Stoltny Irina Kowalska Krzysztof Strojek Dorota Zozulinska-Ziolkiewicz Maciej T. Malecki Maciej T. Malecki |
| author_sort | Jerzy Hohendorff |
| collection | DOAJ |
| description | BackgroundContinuous glucose monitoring (CGM) improves glycemic control and quality of life. Data on glycemic indices and fear of hypoglycemia (FoH) in newly diagnosed T1DM patients are limited.AimTo assess the impact of initiating intermittently scanned CGM (isCGM) within 1–6 months of diagnosis on glycemic control and FoH in adults with T1DM.Subjects and methodsAfter wearing a blinded sensor for 14 days, participants were randomized (1:1) to either isCGM (intervention) or self-monitoring blood glucose (SMBG) with glucometers and blinded CGM (control). Primary outcomes were changes in time below 70 mg/dl (TB70) and FoH, assessed in the Hypoglycemia Fear Survey (HFS). Main secondary outcomes included changes in mean glucose and time in range (TIR) from baseline to 4 weeks after randomization.ResultsThe full analysis set included 23 patients (12 from the intervention group and 11 from the control group), aged 25.6 ± 5.1 years (14 men, 9 women). All participants were on multiple daily insulin injections. TB70 changed from 2.42% to 2.25% in the intervention, and from 2.81% to 1.82% in the control group, and the between-therapy difference of 0.83% was insignificant. No difference between intervention and control groups in change in HFS-worry and HFS-behavior subscales between baseline and after 4 weeks was found (−1.6 ± 3.2 and 1.0 ± 2.2, respectively). The mean glucose levels changed from 7.03 mmol/l to 6.73 mmol/l and from 7.07 mmol/l to 7.43 mmol/l, in the intervention and control groups, respectively, which resulted in a between-therapy significant glucose difference of −0.66 mmol/l. The mean TIR changed from 88.0% to 90.0% in the intervention group and from 85.2 to 84.1% in the control group—the between-therapy difference was insignificant (3,1%). The study ended early due to CGM reimbursement policy changes, after which most patients eligible for the study could have isCGM reimbursed.ConclusionsIn newly diagnosed T1DM adults, TIR is high and hypoglycemia risk is low. The study group was small; however, the data suggest that the use of isCGM soon after T1DM diagnosis could result in mean glucose decrease, but not in change in TB70 and FoH. |
| format | Article |
| id | doaj-art-330bcbc09dda4b61b80858b8647fd1e7 |
| institution | Kabale University |
| issn | 1664-2392 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Endocrinology |
| spelling | doaj-art-330bcbc09dda4b61b80858b8647fd1e72025-01-09T05:10:19ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922025-01-011510.3389/fendo.2024.15038911503891Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trialJerzy Hohendorff0Jerzy Hohendorff1Agata Grzelka-Wozniak2Marta Wrobel3Michal Kania4Michal Kania5Lidia Lapinska6Dominika Rokicka7Dorota Stoltny8Irina Kowalska9Krzysztof Strojek10Dorota Zozulinska-Ziolkiewicz11Maciej T. Malecki12Maciej T. Malecki13Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, PolandInternal Medicine, Metabolic Diseases and Diabetology Clinical Department, University Hospital in Krakow, Krakow, PolandDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, PolandDepartment of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze, Medical University of Silesia, Katowice, PolandDepartment of Metabolic Diseases, Jagiellonian University Medical College, Krakow, PolandInternal Medicine, Metabolic Diseases and Diabetology Clinical Department, University Hospital in Krakow, Krakow, PolandDepartment of Internal Medicine and Metabolic Diseases, Medical University of Bialystok, Bialystok, PolandDepartment of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze, Medical University of Silesia, Katowice, PolandDepartment of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze, Medical University of Silesia, Katowice, PolandDepartment of Internal Medicine and Metabolic Diseases, Medical University of Bialystok, Bialystok, PolandDepartment of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze, Medical University of Silesia, Katowice, PolandDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, PolandDepartment of Metabolic Diseases, Jagiellonian University Medical College, Krakow, PolandInternal Medicine, Metabolic Diseases and Diabetology Clinical Department, University Hospital in Krakow, Krakow, PolandBackgroundContinuous glucose monitoring (CGM) improves glycemic control and quality of life. Data on glycemic indices and fear of hypoglycemia (FoH) in newly diagnosed T1DM patients are limited.AimTo assess the impact of initiating intermittently scanned CGM (isCGM) within 1–6 months of diagnosis on glycemic control and FoH in adults with T1DM.Subjects and methodsAfter wearing a blinded sensor for 14 days, participants were randomized (1:1) to either isCGM (intervention) or self-monitoring blood glucose (SMBG) with glucometers and blinded CGM (control). Primary outcomes were changes in time below 70 mg/dl (TB70) and FoH, assessed in the Hypoglycemia Fear Survey (HFS). Main secondary outcomes included changes in mean glucose and time in range (TIR) from baseline to 4 weeks after randomization.ResultsThe full analysis set included 23 patients (12 from the intervention group and 11 from the control group), aged 25.6 ± 5.1 years (14 men, 9 women). All participants were on multiple daily insulin injections. TB70 changed from 2.42% to 2.25% in the intervention, and from 2.81% to 1.82% in the control group, and the between-therapy difference of 0.83% was insignificant. No difference between intervention and control groups in change in HFS-worry and HFS-behavior subscales between baseline and after 4 weeks was found (−1.6 ± 3.2 and 1.0 ± 2.2, respectively). The mean glucose levels changed from 7.03 mmol/l to 6.73 mmol/l and from 7.07 mmol/l to 7.43 mmol/l, in the intervention and control groups, respectively, which resulted in a between-therapy significant glucose difference of −0.66 mmol/l. The mean TIR changed from 88.0% to 90.0% in the intervention group and from 85.2 to 84.1% in the control group—the between-therapy difference was insignificant (3,1%). The study ended early due to CGM reimbursement policy changes, after which most patients eligible for the study could have isCGM reimbursed.ConclusionsIn newly diagnosed T1DM adults, TIR is high and hypoglycemia risk is low. The study group was small; however, the data suggest that the use of isCGM soon after T1DM diagnosis could result in mean glucose decrease, but not in change in TB70 and FoH.https://www.frontiersin.org/articles/10.3389/fendo.2024.1503891/fullisCGMfear of hypoglycemiaTIRTBRtype 1 diabetes |
| spellingShingle | Jerzy Hohendorff Jerzy Hohendorff Agata Grzelka-Wozniak Marta Wrobel Michal Kania Michal Kania Lidia Lapinska Dominika Rokicka Dorota Stoltny Irina Kowalska Krzysztof Strojek Dorota Zozulinska-Ziolkiewicz Maciej T. Malecki Maciej T. Malecki Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial Frontiers in Endocrinology isCGM fear of hypoglycemia TIR TBR type 1 diabetes |
| title | Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial |
| title_full | Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial |
| title_fullStr | Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial |
| title_full_unstemmed | Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial |
| title_short | Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial |
| title_sort | impact of the initiation of iscgm soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia a randomized controlled trial |
| topic | isCGM fear of hypoglycemia TIR TBR type 1 diabetes |
| url | https://www.frontiersin.org/articles/10.3389/fendo.2024.1503891/full |
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