Diabetes
Conditions
Keywords
Type 1 Diabetes
Brief summary
Evaluation of the biomedical and psychosocial impact of automated Closed-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy
Detailed description
An open-label, multi-centre, randomized, two-arm parallel group trial comparing automated closed-loop and standard insulin delivery. 124 pregnant women between 18 and 45 years of age with Type 1 Diabetes of at least 12 months' duration on standard insulin delivery (CSII or MDI) will be recruited through outpatient antenatal diabetes clinics. Women fulfilling the eligibility criteria will be randomized to automated insulin delivery (AiD) or to continue standard patient-directed insulin delivery (CSII or MDI) without AiD. The study will take place within the home and NHS antenatal clinical settings. Additional blood samples for the research will be obtained at the 24th and 34th week of pregnancy and questionnaires will also be completed by the participant at the 34th week of pregnancy. Following this we will collect information on the birth. 25 of the woman randomised to the closed loop insulin delivery system will also be interviewed to gain more information on, among other things, their existing diabetes management practices, everyday work and family lives and their experience with the device.
Interventions
DEVICEAutomated closed-loop insulin delivery (AiD)
Closed-loop systems are designed to deliver insulin in response to CGM glucose levels and may help to improve glucose control above and beyond what is currently achievable using insulin pumps, injections and CGM without AiD.
DEVICEA standard insulin delivery system
Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.
Sponsors
University of East Anglia
University of Cambridge
University of Leeds
University of Edinburgh
University of Glasgow
King's College London
Belfast Health and Social Care Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an unblinded trial. Both participants and their clinical care team will be aware of the allocation.
Intervention model description
An open-label, multi-centre, randomized, two-arm parallel group trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Between 18 and 45 years of age (inclusive). 2. A diagnosis of type 1 diabetes (T1D), as defined by WHO for at least 12 months. 3. A viable pregnancy confirmed by ultrasound, up to 13 weeks and 6 days gestation. 4. Currently on intensive insulin therapy (≥3 injections or CSII). 5. Willingness to use the study devices throughout the trial. 6. HbA1c level ≥48 mmol/mol (≥6.5%) at booking (first antenatal contact) and ≤86 mmol/mol (≤10%) at point of randomization. 7. Able to provide informed consent. 8. Have access to email.
Exclusion criteria
1. Non-type 1 diabetes. 2. Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results e.g. untreated coeliac disease or untreated hypothyroidism. 3. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors. 4. Known or suspected allergy against insulin. 5. Women with advanced nephropathy (eGFR \<45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results. 6. Very good or very poor glycaemic control i.e. first antenatal HbA1c \<48 mmol/mol (\<6.5%) and current HbA1c \>10% (\>86 mmol/mol). Women who enter pregnancy with HbA1c \>10% (\>86 mmol/mol) may participate if they achieve HbA1c ≤10% (≤86 mmol/mol) before randomization. 7. Total daily insulin dose 1.5 IU/kg. 8. Severe visual or hearing impairment. 9. Unable to speak and understand English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time spent with glucose levels between 3.5-7.8 mmol/L based on CGM measures (Time In Range TIR 3.5-7.8mmol/L) | Between 16 weeks gestation and delivery - an average of 18 weeks | The primary outcome is the percentage of time spent with glucose levels between 3.9-7.8 mmol/L based on CGM levels between 16 weeks gestation and delivery.as compared with standard self-directed insulin delivery in pregnant women with T1D. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM glucose index (Low) | Between 16 weeks gestation and delivery - an average of 18 weeks | The Low Blood Glucose Index (LBGI) |
| CGM glucose index (High) | Between 16 weeks gestation and delivery - an average of 18 weeks | High Blood Glucose Index (HBGI) measures |
| HbA1c testing (Maternal) | Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks | To assess the change of HbA1c in the maternal level. |
| Diabetic ketoacidosis. | An average of 24 weeks | The frequency and severity of diabetic ketoacidosis |
| Severe hypoglycaemia episodes. | An average of 24 weeks | The frequency and severity of hypoglycaemia episodes defined as CGM glucose levels \<3.5 mmol/L (level 1 hypoglycaemia) and \<2.8 mmol/L (level 2 hypoglycaemia) for at least 15 minutes. Distinct episodes must be separated for at least 30 minutes. |
| The number and severity of episodes of adverse device effect. | <24 weeks gestation until delivery - an average of 16 weeks | Adverse events including pregnancy loss, stillbirth, neonatal death |
| Hospital length of stay (maternal). | Between 13 and 40 weeks - an average of 24 weeks | Hospital length of stay (all admissions including the delivery admission) |
| CGM glucose measures | Between 16 weeks gestation and delivery - an average of 18 weeks | The time spent with CGM glucose levels above and below target range, using the mean CGM glucose and CGM glucose variability measures (CV, SD). |
| Gestational age at delivery | At >34 weeks (delivery) | The gestational age at delivery and indication for any preterm delivery (\<37 weeks). Measured in years. |
| Infant birth weight (LGA) | At >34 weeks (delivery) | Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA). |
| Infant birth weight (SGA). | At >34 weeks (delivery) | Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA). |
| Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress). | Between delivery and 40 weeks - an average of 6 weeks | Neonatal morbidity including treatment for neonatal hypoglycaemia, neonatal jaundice and respiratory distress. |
| Neonatal intensive care unit (NICU) admission. | NICU admission after 24 hours | Neonatal intensive care unit (NICU) admission \>24 hours |
| Hospital length of stay (infant). | Between delivery and 40 weeks - an average of 6 weeks | Hospital length of stay for the infant |
| Mode of delivery | At >34 weeks (delivery) | How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section) |
Countries
United Kingdom
Outcome results
None listed