TY - JOUR
T1 - AiDAPT: Automated insulin Delivery Amongst Pregnant women with Type 1 diabetes
T2 - A multicentre randomized controlled trial – study protocol
AU - Lee, Tara
AU - Collett, Corinne
AU - Man, Mei-See
AU - Hammond, Matt
AU - Shepstone, Lee
AU - Hartnell, Sara
AU - Gurnell, Eleanor
AU - Byrne, Caroline
AU - Scott, Eleanor M
AU - Lindsay, Robert
AU - Morris, Damian
AU - Brackenridge, Anna
AU - Dover, Anna
AU - Reynolds, Rebecca
AU - Hunt, Katharine
AU - McCrance, David
AU - Barnard-Kelly, Katharine
AU - Rankin, David
AU - Lawton, Julia
AU - Bocchino, Laura
AU - Sibayan, Judy
AU - Kollman, Craig
AU - Wilinska, Malgorzata E
AU - Hovorka, Roman
AU - Murphy, Helen R
N1 - Funding Information:
Our friend and co-author Professor Fiona Denison (University of Edinburgh, Scotland) died after Covid-19 devastated her mental health and wellbeing. She contributed to the design of AiDAPT over many years, and sadly died during the preparation of this manuscript. She is much missed; https://www.bmj.com/content/376/bmj.o237. We are grateful to all the trial participants, their partners and babies who have enthusiastically supported our research. We would also like to acknowledge our Patient Public Involvement contributors, Mrs. Sarah Cains and Ms. Goher Ayman for their invaluable input into the development of the study protocol, and key management decisions via their trial steering committee attendances. We also thank Emma Flanagan and Glenn Harden and staff at the Norwich Clinical Trials Unit for running this trial. For technical CGM support, training of trial staff and ensuring procurement of CGM devices throughout the Covid-19 lockdowns, we particularly thank Stefania Guerra (Manager Clinical Science Liaison, Dexcom, Edinburgh, UK). For assistance with the complex legal, financial and contractual issues we sincerely thank Mercedes Mills, Graham Horne and Tracy Moulton (Research and Innovation services, University of East Anglia, Norwich UK). AiDAPT Collaborative Group. Katharine Hunt, Helen Rogers, King’s College Hospital, London, UK. Damian Morris, Duncan Fowler, Josephine Rosier, Zeenat Banu, Sarah Barker, Gerry Rayman Ipswich Hospital NHS Trust, Ipswich, UK. Eleanor Gurnell, Caroline Byrne, Andrea Lake, Katy Davenport, Jeannie Grisoni, Shannon Savine Cambridge University Hospitals NHS Foundation Trust, Cambridge , UK. Helen Murphy, Tara Lee, Tara Wallace, Alastair McKelvey, Elizabeth Turner, Nina Willer, Norfolk and Norwich University Hospital, Norwich, UK. Corinne Collett, Mei-See Man, Emma Flanagan, Matt Hammond, Lee Shepstone, Norwich Clinical Trials Unit, Norwich, UK. Anna Brackenridge, Sara White, Anna Reid, Olanike Okolo, Guys and St Thomas’ NHS Foundation Trust, London, UK. Eleanor Scott, Del Endersby Leeds Teaching Hospitals NHS Trust, Leeds, UK. Anna Dover, Frances Dougherty, Susan Johnston, Rebecca Reynolds, Royal Infirmary of Edinburgh, Edinburgh, UK. Robert Lindsay, David Carty, Sharon Mackin, Isobel Crawford, Ross Buchan, Glasgow Royal Infirmary, Glasgow, UK. David McCance, Louisa Jones, Joanne Quinn, Belfast Health and Social Care Trust, Belfast, Northern Ireland. Sarah Cains, Goher Ayman Patient and Public Involvement (PPI) Leads.
Funding Information:
The trial is funded by the National Institute for Health Research Efficacy and Mechanism Evaluation programme (NIHR EME reference 16/35/01). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the UK Department of Health. Data management and statistical centre support from JDRF awards #22-2013-266 and #2-RSC-2019-828-M-N.
Funding Information:
Dr. Tara TM Lee is funded by a Diabetes Research & Wellness Foundation Sutherland-Earl Clinical Fellowship (reference SECF/21).
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/4/5
Y1 - 2022/4/5
N2 - BACKGROUND: Pregnant women with type 1 diabetes strive for tight glucose targets (3.5-7.8 mmol/L) to minimise the risks of obstetric and neonatal complications. Despite using diabetes technologies including continuous glucose monitoring (CGM), insulin pumps and contemporary insulin analogues, most women struggle to achieve and maintain the recommended pregnancy glucose targets. This study aims to evaluate whether the use of automated closed-loop insulin delivery improves antenatal glucose levels in pregnant women with type 1 diabetes.METHODS/DESIGN: A multicentre, open label, randomized, controlled trial of pregnant women with type 1 diabetes and a HbA1c of ≥48 mmol/mol (6.5%) at pregnancy confirmation and ≤ 86 mmol/mol (10%) at randomization. Participants who provide written informed consent before 13 weeks 6 days gestation will be entered into a run-in phase to collect 96 h (24 h overnight) of CGM glucose values. Eligible participants will be randomized on a 1:1 basis to CGM (Dexcom G6) with usual insulin delivery (control) or closed-loop (intervention). The closed-loop system includes a model predictive control algorithm (CamAPS FX application), hosted on an android smartphone that communicates wirelessly with the insulin pump (Dana Diabecare RS) and CGM transmitter. Research visits and device training will be provided virtually or face-to-face in conjunction with 4-weekly antenatal clinic visits where possible. Randomization will stratify for clinic site. One hundred twenty-four participants will be recruited. This takes into account 10% attrition and 10% who experience miscarriage or pregnancy loss. Analyses will be performed according to intention to treat. The primary analysis will evaluate the change in the time spent in the target glucose range (3.5-7.8 mmol/l) between the intervention and control group from 16 weeks gestation until delivery. Secondary outcomes include overnight time in target, time above target (> 7.8 mmol/l), standard CGM metrics, HbA1c and psychosocial functioning and health economic measures. Safety outcomes include the number and severity of ketoacidosis, severe hypoglycaemia and adverse device events.DISCUSSION: This will be the largest randomized controlled trial to evaluate the impact of closed-loop insulin delivery during type 1 diabetes pregnancy.TRIAL REGISTRATION: ISRCTN 56898625 Registration Date: 10 April, 2018.
AB - BACKGROUND: Pregnant women with type 1 diabetes strive for tight glucose targets (3.5-7.8 mmol/L) to minimise the risks of obstetric and neonatal complications. Despite using diabetes technologies including continuous glucose monitoring (CGM), insulin pumps and contemporary insulin analogues, most women struggle to achieve and maintain the recommended pregnancy glucose targets. This study aims to evaluate whether the use of automated closed-loop insulin delivery improves antenatal glucose levels in pregnant women with type 1 diabetes.METHODS/DESIGN: A multicentre, open label, randomized, controlled trial of pregnant women with type 1 diabetes and a HbA1c of ≥48 mmol/mol (6.5%) at pregnancy confirmation and ≤ 86 mmol/mol (10%) at randomization. Participants who provide written informed consent before 13 weeks 6 days gestation will be entered into a run-in phase to collect 96 h (24 h overnight) of CGM glucose values. Eligible participants will be randomized on a 1:1 basis to CGM (Dexcom G6) with usual insulin delivery (control) or closed-loop (intervention). The closed-loop system includes a model predictive control algorithm (CamAPS FX application), hosted on an android smartphone that communicates wirelessly with the insulin pump (Dana Diabecare RS) and CGM transmitter. Research visits and device training will be provided virtually or face-to-face in conjunction with 4-weekly antenatal clinic visits where possible. Randomization will stratify for clinic site. One hundred twenty-four participants will be recruited. This takes into account 10% attrition and 10% who experience miscarriage or pregnancy loss. Analyses will be performed according to intention to treat. The primary analysis will evaluate the change in the time spent in the target glucose range (3.5-7.8 mmol/l) between the intervention and control group from 16 weeks gestation until delivery. Secondary outcomes include overnight time in target, time above target (> 7.8 mmol/l), standard CGM metrics, HbA1c and psychosocial functioning and health economic measures. Safety outcomes include the number and severity of ketoacidosis, severe hypoglycaemia and adverse device events.DISCUSSION: This will be the largest randomized controlled trial to evaluate the impact of closed-loop insulin delivery during type 1 diabetes pregnancy.TRIAL REGISTRATION: ISRCTN 56898625 Registration Date: 10 April, 2018.
KW - Blood Glucose Self-Monitoring
KW - Blood Glucose/analysis
KW - Diabetes Mellitus, Type 1/drug therapy
KW - Female
KW - Humans
KW - Hypoglycemic Agents/therapeutic use
KW - Infant, Newborn
KW - Insulin Infusion Systems
KW - Insulin/therapeutic use
KW - Multicenter Studies as Topic
KW - Pregnancy
KW - Pregnant Women
KW - Randomized Controlled Trials as Topic
U2 - 10.1186/s12884-022-04543-z
DO - 10.1186/s12884-022-04543-z
M3 - Article
C2 - 35382796
SN - 1471-2393
VL - 22
JO - BMC pregnancy and childbirth
JF - BMC pregnancy and childbirth
IS - 1
M1 - 282
ER -