Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial
Introduction There are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes. We aim to compare the effects of isCGM, training in carbohydrate counting with ABC an...
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BMJ Publishing Group
2020-04-01
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| author | Anna Lilja Secher Ulrik Pedersen-Bjergaard Ole Lander Svendsen Birthe Gade-Rasmussen Thomas P Almdal Liv Dørflinger Dorte Vistisen Kirsten Nørgaard |
| author_facet | Anna Lilja Secher Ulrik Pedersen-Bjergaard Ole Lander Svendsen Birthe Gade-Rasmussen Thomas P Almdal Liv Dørflinger Dorte Vistisen Kirsten Nørgaard |
| author_sort | Anna Lilja Secher |
| collection | DOAJ |
| description | Introduction There are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes. We aim to compare the effects of isCGM, training in carbohydrate counting with ABC and the combination of the two concepts with standard care.Methods and analysis A multi-centre randomised controlled trial with inclusion criteria: ≥18 years, type 1 diabetes ≥1 year, injection therapy, HbA1c >53 mmol/mol, whereas daily use of carbohydrate counting and/or CGM/isCGM wear are exclusion criteria. Inclusion was initiated in October 2018 and is ongoing. Eligible persons are randomised into four groups: standard care, ABC, isCGM or ABC+isCGM. Devices used are FreeStyle Libre Flash and smart phone diabetes application mySugr. Participants attend group courses according to treatment allocation with different educational contents. Participants are followed for 26 weeks with clinical visits and telephone consultations. At baseline and at study end, participants wear blinded CGM, have blood samples performed and fill in questionnaires on person-related outcomes, and at baseline also on personality traits and hypoglycaemia awareness. The primary outcome is the difference in time spent in normoglycaemia (4–10 mmol/L) at study end versus baseline between the isCGM group and the standard care group. Secondary outcomes will also be analysed. Results are expected in 2020.Ethics and dissemination Regional Scientific Ethics Committee approval (H-17040573). Results will be sought disseminated at conferences and in high impact journals.Trial registration numberClinicalTrial.gov registry (NCT03682237). |
| format | Article |
| id | doaj-art-75bcf50b54574958a89c12ce10c69527 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-75bcf50b54574958a89c12ce10c695272024-12-03T17:30:09ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-036474Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trialAnna Lilja Secher0Ulrik Pedersen-Bjergaard1Ole Lander Svendsen2Birthe Gade-Rasmussen3Thomas P Almdal4Liv Dørflinger5Dorte Vistisen6Kirsten Nørgaard7Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, DenmarkFaculty of Health and Medical Sciences, Copenhagen University, Copenhagen, DenmarkDepartment of Endocrinology I, Bispebjerg Hospital, Kobenhavn, DenmarkDepartment of Endocrinology, Hvidovre Hospital, Hvidovre, DenmarkDepartment of Endocrinology, Rigshospitalet, Kobenhavn, DenmarkAdministration, Steno Diabetes Center Copenhagen, Gentofte, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkClinical Research, Steno Diabetes Center Copenhagen, Gentofte, DenmarkIntroduction There are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes. We aim to compare the effects of isCGM, training in carbohydrate counting with ABC and the combination of the two concepts with standard care.Methods and analysis A multi-centre randomised controlled trial with inclusion criteria: ≥18 years, type 1 diabetes ≥1 year, injection therapy, HbA1c >53 mmol/mol, whereas daily use of carbohydrate counting and/or CGM/isCGM wear are exclusion criteria. Inclusion was initiated in October 2018 and is ongoing. Eligible persons are randomised into four groups: standard care, ABC, isCGM or ABC+isCGM. Devices used are FreeStyle Libre Flash and smart phone diabetes application mySugr. Participants attend group courses according to treatment allocation with different educational contents. Participants are followed for 26 weeks with clinical visits and telephone consultations. At baseline and at study end, participants wear blinded CGM, have blood samples performed and fill in questionnaires on person-related outcomes, and at baseline also on personality traits and hypoglycaemia awareness. The primary outcome is the difference in time spent in normoglycaemia (4–10 mmol/L) at study end versus baseline between the isCGM group and the standard care group. Secondary outcomes will also be analysed. Results are expected in 2020.Ethics and dissemination Regional Scientific Ethics Committee approval (H-17040573). Results will be sought disseminated at conferences and in high impact journals.Trial registration numberClinicalTrial.gov registry (NCT03682237).https://bmjopen.bmj.com/content/10/4/e036474.full |
| spellingShingle | Anna Lilja Secher Ulrik Pedersen-Bjergaard Ole Lander Svendsen Birthe Gade-Rasmussen Thomas P Almdal Liv Dørflinger Dorte Vistisen Kirsten Nørgaard Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial BMJ Open |
| title | Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial |
| title_full | Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial |
| title_fullStr | Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial |
| title_full_unstemmed | Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial |
| title_short | Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial |
| title_sort | study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections intermittently scanned continuous glucose monitoring carbohydrate counting with automated bolus calculation or both a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/4/e036474.full |
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