CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial
Introduction Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart...
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BMJ Publishing Group
2021-04-01
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| author | Peter Damm Lene Ringholm Tine Dalsgaard Clausen Sidse Kjærhus Nørgaard Elisabeth Reinhardt Mathiesen |
| author_facet | Peter Damm Lene Ringholm Tine Dalsgaard Clausen Sidse Kjærhus Nørgaard Elisabeth Reinhardt Mathiesen |
| author_sort | Peter Damm |
| collection | DOAJ |
| description | Introduction Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health.Methods and analysis An open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle.Ethics and dissemination The trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings.Trial registration number NCT03770767 |
| format | Article |
| id | doaj-art-1d9b8533bb11427caa2b4755da0547f7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-1d9b8533bb11427caa2b4755da0547f72024-11-18T04:20:09ZengBMJ Publishing GroupBMJ Open2044-60552021-04-0111410.1136/bmjopen-2020-045650CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trialPeter Damm0Lene Ringholm1Tine Dalsgaard Clausen2Sidse Kjærhus Nørgaard3Elisabeth Reinhardt Mathiesen48 Center for Pregnant Women with Diabetes, Department of Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark6 Center for Pregnant Women with Diabetes, Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, DenmarkCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, DenmarkCenter for Pregnant Women with Diabetes, Departments of Endocrinology and Obstetrics, Rigshospitalet, Copenhagen, DenmarkIntroduction Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health.Methods and analysis An open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle.Ethics and dissemination The trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings.Trial registration number NCT03770767https://bmjopen.bmj.com/content/11/4/e045650.full |
| spellingShingle | Peter Damm Lene Ringholm Tine Dalsgaard Clausen Sidse Kjærhus Nørgaard Elisabeth Reinhardt Mathiesen CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial BMJ Open |
| title | CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial |
| title_full | CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial |
| title_fullStr | CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial |
| title_full_unstemmed | CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial |
| title_short | CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial |
| title_sort | copenfast trial faster acting insulin fiasp versus insulin novorapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/4/e045650.full |
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