Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study
Introduction Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use...
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BMJ Publishing Group
2025-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/5/e098457.full |
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| author | Yee Wen Kong Sara Vogrin Elif Ekinci Pamela Taylor David Norman O’Neal Alicia Jenkins Stephen N Stranks Steven Trawley Christopher J Nolan Lynelle Boisseau Jennifer Ngan Jenna Goad Michael L H Huang Adele Manzoney Miyuki Nakano Adamandia Kriketos Spiros Fourlanos Joanne Fenn |
| author_facet | Yee Wen Kong Sara Vogrin Elif Ekinci Pamela Taylor David Norman O’Neal Alicia Jenkins Stephen N Stranks Steven Trawley Christopher J Nolan Lynelle Boisseau Jennifer Ngan Jenna Goad Michael L H Huang Adele Manzoney Miyuki Nakano Adamandia Kriketos Spiros Fourlanos Joanne Fenn |
| author_sort | Yee Wen Kong |
| collection | DOAJ |
| description | Introduction Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use of continuous ketone monitoring (CKM) and education strategies to mitigate progression to DKA, will demonstrate improved glycaemic control without increasing DKA events.Methods and analysis PARTNER is a multisite 6-month randomised crossover double-masked study involving Australian adults with T1D who have a Haemoglobin A1c (HbA1c) <85.8 mmol/mol (<10%), minimum total daily insulin dose ≥0.4 IU/kg, consume ≥100 g carbohydrates/day and have not had DKA in the last 3 months. All participants will undergo a 2-week run-in period wearing the Abbott FreeStyle Libre 2 Continuous Glucose Monitor (CGM) and Abbott CKM device. Following this, participants are randomised to receive dapagliflozin or placebo for 12 weeks, followed by crossover for a further 12 weeks separated by a 2-week washout period. The primary effectiveness outcome is the Abbott FreeStyle Libre 2 CGM time in range during the final 2 weeks of each stage. The primary safety outcome is the number of episodes of DKA requiring hospitalisation or emergency department presentation. 60 participants will be recruited across five sites.Ethics and dissemination The study has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC reference 302/23). The results will be published in peer-reviewed journals and presented at national and international diabetes conferences.Trial registration number ACTRN12624000448549. |
| format | Article |
| id | doaj-art-c39209b917ef4b6caeff0fd38acf48dc |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c39209b917ef4b6caeff0fd38acf48dc2025-08-20T02:27:23ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-098457Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER studyYee Wen Kong0Sara Vogrin1Elif Ekinci2Pamela Taylor3David Norman O’Neal4Alicia Jenkins5Stephen N Stranks6Steven Trawley7Christopher J Nolan8Lynelle Boisseau9Jennifer Ngan10Jenna Goad11Michael L H Huang12Adele Manzoney13Miyuki Nakano14Adamandia Kriketos15Spiros Fourlanos16Joanne Fenn17Department of Medicine, University of Melbourne, Melbourne, Victoria, AustraliaDepartment of Medicine, University of Melbourne, Fitzroy, Victoria, AustraliaDepartment of Medicine, University of Melbourne, Fitzroy, Victoria, AustraliaSouthern Adelaide Diabetes and Endocrine Services, Oaklands Park, South Australia, AustraliaDepartment of Endocrinology and Diabetes, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, AustraliaDepartment of Endocrinology and Diabetes, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, AustraliaSouthern Adelaide Diabetes and Endocrine Services, Oaklands Park, South Australia, AustraliaCairnmillar Institute, Hawthorn, Victoria, AustraliaAustralian Centre for Accelerating Diabetes Innovations, School of Medicine, University of Melbourne, Parkville, Victoria, AustraliaDepartment of Diabetes and Endocrinology, Canberra Health Services, Garran, Canberra, AustraliaDepartment of Endocrinology and Diabetes, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, AustraliaDepartment of Medicine, University of Melbourne, Fitzroy, Victoria, AustraliaBaker Heart and Diabetes Institute, Melbourne, Victoria, AustraliaDepartment of Endocrinology and Centre for Research in Education in Diabetes and Obesity, Austin Health, Heidelberg, Victoria, AustraliaDepartment of Endocrinology and Centre for Research in Education in Diabetes and Obesity, Austin Health, Heidelberg, Victoria, AustraliaDepartment of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, AustraliaDepartment of Medicine, University of Melbourne, Fitzroy, Victoria, AustraliaSouthern Adelaide Diabetes and Endocrine Services, Oaklands Park, South Australia, AustraliaIntroduction Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use of continuous ketone monitoring (CKM) and education strategies to mitigate progression to DKA, will demonstrate improved glycaemic control without increasing DKA events.Methods and analysis PARTNER is a multisite 6-month randomised crossover double-masked study involving Australian adults with T1D who have a Haemoglobin A1c (HbA1c) <85.8 mmol/mol (<10%), minimum total daily insulin dose ≥0.4 IU/kg, consume ≥100 g carbohydrates/day and have not had DKA in the last 3 months. All participants will undergo a 2-week run-in period wearing the Abbott FreeStyle Libre 2 Continuous Glucose Monitor (CGM) and Abbott CKM device. Following this, participants are randomised to receive dapagliflozin or placebo for 12 weeks, followed by crossover for a further 12 weeks separated by a 2-week washout period. The primary effectiveness outcome is the Abbott FreeStyle Libre 2 CGM time in range during the final 2 weeks of each stage. The primary safety outcome is the number of episodes of DKA requiring hospitalisation or emergency department presentation. 60 participants will be recruited across five sites.Ethics and dissemination The study has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC reference 302/23). The results will be published in peer-reviewed journals and presented at national and international diabetes conferences.Trial registration number ACTRN12624000448549.https://bmjopen.bmj.com/content/15/5/e098457.full |
| spellingShingle | Yee Wen Kong Sara Vogrin Elif Ekinci Pamela Taylor David Norman O’Neal Alicia Jenkins Stephen N Stranks Steven Trawley Christopher J Nolan Lynelle Boisseau Jennifer Ngan Jenna Goad Michael L H Huang Adele Manzoney Miyuki Nakano Adamandia Kriketos Spiros Fourlanos Joanne Fenn Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study BMJ Open |
| title | Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study |
| title_full | Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study |
| title_fullStr | Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study |
| title_full_unstemmed | Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study |
| title_short | Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study |
| title_sort | rationale and design of a randomised phase ii multicentre crossover trial investigating a sodium glucose co transporter 2 inhibitor dapagliflozin combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis the partner study |
| url | https://bmjopen.bmj.com/content/15/5/e098457.full |
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