Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial
IntroductionAs many people with type 1 diabetes find it hard to reach the recommended glycemic goals, even with CGM, this study aims to determine if a closer, digitally supported collaboration on interpreting CGM data together with a diabetes nurse can improve glycemic control.Methods and analysisA...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-10-01
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| Series: | Frontiers in Clinical Diabetes and Healthcare |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcdhc.2023.1247616/full |
| _version_ | 1797657347999399936 |
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| author | Arndís F. Ólafsdóttir Arndís F. Ólafsdóttir Arndís F. Ólafsdóttir Marcus Lind Marcus Lind Marcus Lind |
| author_facet | Arndís F. Ólafsdóttir Arndís F. Ólafsdóttir Arndís F. Ólafsdóttir Marcus Lind Marcus Lind Marcus Lind |
| author_sort | Arndís F. Ólafsdóttir |
| collection | DOAJ |
| description | IntroductionAs many people with type 1 diabetes find it hard to reach the recommended glycemic goals, even with CGM, this study aims to determine if a closer, digitally supported collaboration on interpreting CGM data together with a diabetes nurse can improve glycemic control.Methods and analysisA total of 120 individuals, 18 years and older and with HbA1c ≥ 58 mmol/mol will be included in the study at 8 different sites in Sweden and Norway. To be included, the participants must use a CGM or isCGM and be able to upload the data to the appropriate online service for their clinic and sensor. Both those with insulin pumps and insulin pens will be included in the study. Participants will be randomized into two different groups, that is, the intensive therapy group and the control group. The intensive therapy group will upload their glucose data weekly for the first 4 months and have telephone contact with their diabetes care team to receive support in interpreting CGM data and taking appropriate actions if their mean blood glucose level is above 8.4 mmol/L. After the 4-month-long intensive treatment phase, both randomized groups will have the same number of clinical visits and receive the same type of diabetes support.DiscussionIt is of great importance to find new ways to help people with type 1 diabetes manage their condition as well as they can to help them achieve better glycemic control so that hopefully more people can achieve the recommended glycemic goals, which are associated with fewer diabetes complications. If it is shown that people with type 1 diabetes achieve better glycemic control with intensive therapy, then this can be incorporated into clinical praxis as an option for those not currently reaching the recommended glycemic goals.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT03474393?locStr=Uddevalla,%20Sweden&country=Sweden&distance=50&cond=Diabetes&aggFilters=ages:adult%20older&state=V%C3%A4stra%20G%C3%B6taland%20County&city=Uddevalla&page=4&rank=34, identifier 03474393. |
| first_indexed | 2024-03-11T17:43:11Z |
| format | Article |
| id | doaj.art-bb5260716b0245cf8087e859385cb4d1 |
| institution | Directory Open Access Journal |
| issn | 2673-6616 |
| language | English |
| last_indexed | 2024-03-11T17:43:11Z |
| publishDate | 2023-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Clinical Diabetes and Healthcare |
| spelling | doaj.art-bb5260716b0245cf8087e859385cb4d12023-10-18T09:04:20ZengFrontiers Media S.A.Frontiers in Clinical Diabetes and Healthcare2673-66162023-10-01410.3389/fcdhc.2023.12476161247616Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trialArndís F. Ólafsdóttir0Arndís F. Ólafsdóttir1Arndís F. Ólafsdóttir2Marcus Lind3Marcus Lind4Marcus Lind5Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Medicine, NU Hospital Group, Uddevalla, SwedenDepartment of Medicine, Sahlgrenska University Hospital, Gothenburg, SwedenDepartment of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Medicine, NU Hospital Group, Uddevalla, SwedenDepartment of Medicine, Sahlgrenska University Hospital, Gothenburg, SwedenIntroductionAs many people with type 1 diabetes find it hard to reach the recommended glycemic goals, even with CGM, this study aims to determine if a closer, digitally supported collaboration on interpreting CGM data together with a diabetes nurse can improve glycemic control.Methods and analysisA total of 120 individuals, 18 years and older and with HbA1c ≥ 58 mmol/mol will be included in the study at 8 different sites in Sweden and Norway. To be included, the participants must use a CGM or isCGM and be able to upload the data to the appropriate online service for their clinic and sensor. Both those with insulin pumps and insulin pens will be included in the study. Participants will be randomized into two different groups, that is, the intensive therapy group and the control group. The intensive therapy group will upload their glucose data weekly for the first 4 months and have telephone contact with their diabetes care team to receive support in interpreting CGM data and taking appropriate actions if their mean blood glucose level is above 8.4 mmol/L. After the 4-month-long intensive treatment phase, both randomized groups will have the same number of clinical visits and receive the same type of diabetes support.DiscussionIt is of great importance to find new ways to help people with type 1 diabetes manage their condition as well as they can to help them achieve better glycemic control so that hopefully more people can achieve the recommended glycemic goals, which are associated with fewer diabetes complications. If it is shown that people with type 1 diabetes achieve better glycemic control with intensive therapy, then this can be incorporated into clinical praxis as an option for those not currently reaching the recommended glycemic goals.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT03474393?locStr=Uddevalla,%20Sweden&country=Sweden&distance=50&cond=Diabetes&aggFilters=ages:adult%20older&state=V%C3%A4stra%20G%C3%B6taland%20County&city=Uddevalla&page=4&rank=34, identifier 03474393.https://www.frontiersin.org/articles/10.3389/fcdhc.2023.1247616/fullcontinuous glucose monitor (CGM)intermittent scanning -continuous glucose monitor (isCGM)telemedicinediabetes nursetype 1 diabetesglycemic control |
| spellingShingle | Arndís F. Ólafsdóttir Arndís F. Ólafsdóttir Arndís F. Ólafsdóttir Marcus Lind Marcus Lind Marcus Lind Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial Frontiers in Clinical Diabetes and Healthcare continuous glucose monitor (CGM) intermittent scanning -continuous glucose monitor (isCGM) telemedicine diabetes nurse type 1 diabetes glycemic control |
| title | Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial |
| title_full | Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial |
| title_fullStr | Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial |
| title_full_unstemmed | Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial |
| title_short | Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial |
| title_sort | evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care a protocol for a multi center randomized clinical trial |
| topic | continuous glucose monitor (CGM) intermittent scanning -continuous glucose monitor (isCGM) telemedicine diabetes nurse type 1 diabetes glycemic control |
| url | https://www.frontiersin.org/articles/10.3389/fcdhc.2023.1247616/full |
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