AiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial - study protocol

被引：19

作者：

Lee, Tara T. M. ^{[1
]}

Collett, Corinne ^{[2
]}

Man, Mei-See ^{[2
]}

Hammond, Matt ^{[2
]}

Shepstone, Lee ^{[2
]}

Hartnell, Sara ^{[3
]}

Gurnell, Eleanor ^{[3
]}

Byrne, Caroline ^{[3
]}

Scott, Eleanor M. ^{[4
]}

Lindsay, Robert S. ^{[5
]}

Morris, Damian ^{[6
]}

Brackenridge, Anna ^{[7
]}

Dover, Anna R. ^{[8
]}

Reynolds, Rebecca M. ^{[9
]}

Hunt, Katharine F. ^{[10
]}

McCance, David R. ^{[11
]}

Barnard-Kelly, Katharine ^{[12
]}

Rankin, David ^{[13
]}

Lawton, Julia ^{[13
]}

Bocchino, Laura E. ^{[14
]}

Sibayan, Judy ^{[14
]}

Kollman, Craig ^{[14
]}

Wilinska, Malgorzata E. ^{[15
]}

Hovorka, Roman ^{[15
]}

Murphy, Helen R. ^{[1
,2
]}

机构：

[1] Univ East Anglia, Norwich Med Sch, Floor 2,Bob Champ Res & Educ Bldg, Norwich, Norfolk, England

[2] Univ East Anglia, Norwich Med Sch, Norwich Clin Trials Unit, Norwich, Norfolk, England

[3] Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England

[4] Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, W Yorkshire, England

[5] Univ Glasgow, Inst Cardiovasc & Med Sci, Glasgow, Lanark, Scotland

[6] East Suffolk & North Essex Fdn Trust, Ipswich Hosp, Dept Diabet & Endocrinol, Ipswich, Suffolk, England

[7] Guys & St Thomas NHS Fdn Trust, Dept Diabet & Endocrinol, London, England

[8] Royal Infirm Edinburgh NHS Trust, Edinburgh Ctr Endocrinol & Diabet, Edinburgh, Midlothian, Scotland

[9] Univ Edinburgh, Ctr Cardiovasc Sci, Edinburgh, Midlothian, Scotland

[10] Kings Coll Hosp NHS Fdn Trust, London, England

[11] Royal Victoria Hosp Belfast, Reg Ctr Endocrinol & Diabet, Belfast, Antrim, North Ireland

[12] Barnard Hlth Res Ltd, Southampton, Hants, England

[13] Univ Edinburgh, Usher Inst, Edinburgh, Midlothian, Scotland

[14] Jaeb Ctr Hlth Res, Tampa, FL USA

[15] Univ Cambridge, Wellcome Trust Med Res Council Inst Metab Sci, Cambridge, England

来源：

BMC PREGNANCY AND CHILDBIRTH | 2022年 / 22卷 / 01期

基金：

美国国家卫生研究院;

关键词：

CLOSED-LOOP CONTROL; HYPOGLYCEMIA; CHILDREN; HBA(1C);

D O I：

10.1186/s12884-022-04543-z

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

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 HbAlc 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 16weeks gestation until delivery. Secondary outcomes include overnight time in target, time above target (>7.8 mmol/l), standard CGM metrics, HbAlc 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.

引用

页数：10

共 31 条

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