Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol
Abstract Background Despite increasing use of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII, insulin pumps) in type 1 diabetes (T1D) in pregnancy, achieving recommended pregnancy glycaemic targets (3.5–7.8 mmol/L or 63–140 mg/dL) remains challenging. Conseque...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12884-023-05481-0 |
| _version_ | 1797863292555755520 |
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| author | Kaat Beunen Nancy Van Wilder Dominique Ballaux Gerd Vanhaverbeke Youri Taes Xavier-Philippe Aers Frank Nobels Joke Marlier Dahae Lee Joke Cuypers Vanessa Preumont Sarah E. Siegelaar Rebecca C. Painter Annouschka Laenen Pieter Gillard Chantal Mathieu Katrien Benhalima |
| author_facet | Kaat Beunen Nancy Van Wilder Dominique Ballaux Gerd Vanhaverbeke Youri Taes Xavier-Philippe Aers Frank Nobels Joke Marlier Dahae Lee Joke Cuypers Vanessa Preumont Sarah E. Siegelaar Rebecca C. Painter Annouschka Laenen Pieter Gillard Chantal Mathieu Katrien Benhalima |
| author_sort | Kaat Beunen |
| collection | DOAJ |
| description | Abstract Background Despite increasing use of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII, insulin pumps) in type 1 diabetes (T1D) in pregnancy, achieving recommended pregnancy glycaemic targets (3.5–7.8 mmol/L or 63–140 mg/dL) remains challenging. Consequently, the risk of adverse pregnancy outcomes remains high. Outside pregnancy, hybrid closed-loop (HCL) insulin delivery systems have led to a paradigm shift in the management of T1D, with 12% higher time in glucose target range (TIR) compared to conventional CSII. However, most commercially available HCL systems are currently not approved for use in pregnancy. This study aims to evaluate the efficacy, safety and cost-effectiveness of the MiniMed™ 780G HCL system (Medtronic) in T1D in pregnancy. Methods In this international, open-label, randomized controlled trial (RCT), we will compare the MiniMed™ 780G HCL system to standard of care (SoC) in T1D in pregnancy. Women aged 18–45 years with T1D diagnosis of at least one year, HbA1c ≤ 86 mmol/mol (≤ 10%), and confirmed singleton pregnancy up to 11 weeks 6 days will be eligible. After providing written informed consent, all participants will wear a similar CGM system (Guardian™ 3 or Guardian™ 4 CGM) during a 10-day run-in phase. After the run-in phase, participants will be randomised 1:1 to 780G HCL (intervention) or SoC [control, continuation of current T1D treatment with multiple daily injections (MDI) or CSII and any type of CGM] stratified according to centre, baseline HbA1c (< 53 vs. ≥ 53 mmol/mol or < 7 vs. ≥ 7%), and method of insulin delivery (MDI or CSII). The primary outcome will be the time spent within the pregnancy glucose target range, as measured by the CGM at four time points in pregnancy: 14–17, 20–23, 26–29, and 33–36 weeks. Prespecified secondary outcomes will be overnight TIR, time below range (TBR: <3.5 mmol/L or < 63 mg/dL), and overnight TBR. Other outcomes will be exploratory. The planned sample size is 92 participants. The study will end after postpartum discharge from hospital. Analyses will be performed according to intention-to-treat as well as per protocol. Discussion This large RCT will evaluate a widely used commercially available HCL system in T1D in pregnancy. Recruitment began in January 2021 and was completed in October 2022. Study completion is expected in May 2023. Trial registration ClinicalTrials.gov: NCT04520971. Registration date: August 20, 2020. https://clinicaltrials.gov/ct2/show/NCT04520971 |
| first_indexed | 2024-04-09T22:33:13Z |
| format | Article |
| id | doaj.art-c24146084b6c4636aa5284b05e5710df |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-04-09T22:33:13Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-c24146084b6c4636aa5284b05e5710df2023-03-22T12:39:01ZengBMCBMC Pregnancy and Childbirth1471-23932023-03-0123111110.1186/s12884-023-05481-0Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocolKaat Beunen0Nancy Van Wilder1Dominique Ballaux2Gerd Vanhaverbeke3Youri Taes4Xavier-Philippe Aers5Frank Nobels6Joke Marlier7Dahae Lee8Joke Cuypers9Vanessa Preumont10Sarah E. Siegelaar11Rebecca C. Painter12Annouschka Laenen13Pieter Gillard14Chantal Mathieu15Katrien Benhalima16Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU LeuvenDepartment of Endocrinology, University Hospital BrusselsDepartment of EndocrinologyDepartment of Endocrinology, General Hospital Groeninge KortrijkDepartment of Endocrinology, General Hospital Sint-Jan BruggeDepartment of Endocrinology, General Hospital Delta Campus RumbekeDepartment of Endocrinology, OLV Hospital AalstDepartment of Endocrinology, Ghent University HospitalDepartment of Endocrinology, Imelda Hospital BonheidenDepartment of Endocrinology, General Hospital Turnhout Campus Sint-JozefDepartment of Endocrinology, University Hospital Saint-LucDepartment of Endocrinology and Metabolism, Amsterdam University Medical CentresDepartment of Obstetrics & Gynecology, Amsterdam University Medical CentresCenter of Biostatics and Statistical bioinformatics, KU LeuvenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU LeuvenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU LeuvenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU LeuvenAbstract Background Despite increasing use of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII, insulin pumps) in type 1 diabetes (T1D) in pregnancy, achieving recommended pregnancy glycaemic targets (3.5–7.8 mmol/L or 63–140 mg/dL) remains challenging. Consequently, the risk of adverse pregnancy outcomes remains high. Outside pregnancy, hybrid closed-loop (HCL) insulin delivery systems have led to a paradigm shift in the management of T1D, with 12% higher time in glucose target range (TIR) compared to conventional CSII. However, most commercially available HCL systems are currently not approved for use in pregnancy. This study aims to evaluate the efficacy, safety and cost-effectiveness of the MiniMed™ 780G HCL system (Medtronic) in T1D in pregnancy. Methods In this international, open-label, randomized controlled trial (RCT), we will compare the MiniMed™ 780G HCL system to standard of care (SoC) in T1D in pregnancy. Women aged 18–45 years with T1D diagnosis of at least one year, HbA1c ≤ 86 mmol/mol (≤ 10%), and confirmed singleton pregnancy up to 11 weeks 6 days will be eligible. After providing written informed consent, all participants will wear a similar CGM system (Guardian™ 3 or Guardian™ 4 CGM) during a 10-day run-in phase. After the run-in phase, participants will be randomised 1:1 to 780G HCL (intervention) or SoC [control, continuation of current T1D treatment with multiple daily injections (MDI) or CSII and any type of CGM] stratified according to centre, baseline HbA1c (< 53 vs. ≥ 53 mmol/mol or < 7 vs. ≥ 7%), and method of insulin delivery (MDI or CSII). The primary outcome will be the time spent within the pregnancy glucose target range, as measured by the CGM at four time points in pregnancy: 14–17, 20–23, 26–29, and 33–36 weeks. Prespecified secondary outcomes will be overnight TIR, time below range (TBR: <3.5 mmol/L or < 63 mg/dL), and overnight TBR. Other outcomes will be exploratory. The planned sample size is 92 participants. The study will end after postpartum discharge from hospital. Analyses will be performed according to intention-to-treat as well as per protocol. Discussion This large RCT will evaluate a widely used commercially available HCL system in T1D in pregnancy. Recruitment began in January 2021 and was completed in October 2022. Study completion is expected in May 2023. Trial registration ClinicalTrials.gov: NCT04520971. Registration date: August 20, 2020. https://clinicaltrials.gov/ct2/show/NCT04520971https://doi.org/10.1186/s12884-023-05481-0Type 1 diabetes mellitusPregnancyClosed-loop insulin deliveryAutomated insulin deliveryArtificial pancreas |
| spellingShingle | Kaat Beunen Nancy Van Wilder Dominique Ballaux Gerd Vanhaverbeke Youri Taes Xavier-Philippe Aers Frank Nobels Joke Marlier Dahae Lee Joke Cuypers Vanessa Preumont Sarah E. Siegelaar Rebecca C. Painter Annouschka Laenen Pieter Gillard Chantal Mathieu Katrien Benhalima Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol BMC Pregnancy and Childbirth Type 1 diabetes mellitus Pregnancy Closed-loop insulin delivery Automated insulin delivery Artificial pancreas |
| title | Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol |
| title_full | Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol |
| title_fullStr | Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol |
| title_full_unstemmed | Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol |
| title_short | Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial – study protocol |
| title_sort | closed loop insulin delivery in pregnant women with type 1 diabetes cristal a multicentre randomized controlled trial study protocol |
| topic | Type 1 diabetes mellitus Pregnancy Closed-loop insulin delivery Automated insulin delivery Artificial pancreas |
| url | https://doi.org/10.1186/s12884-023-05481-0 |
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