Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
Treatment arm: 24 hours closed loop insulin delivery (dose titration by computer algorithm)
Control arm: 24 hours of conventional insulin pump delivery (i.e dose titration according to fingerprick glu
Sponsors
Cambridge University Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care. 2. The participant is between 16 and 44 years of age (inclusive), female only 3. The participant has type 1 diabetes (T1DM), as defined by World Health Organisation (WHO) for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound 4. The participant has been commenced on insulin pump therapy during or prior to pregnancy 5. The participant is able and willing to use a real time continuous sensor
Exclusion criteria
Exclusion criteria: 1. Non-type 1 diabetes mellitus including those secondary to chronic disease 2. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results such as coeliac disease or untreated hypothyroidism 3. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and monoamine oxidase (MAO) inhibitors 4. Known or suspected allergy against insulin 5. Women with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 6. Documented gastroparesis 7. Very poor glycaemic control i.e. HbA1c greater than or equal to 10% 8. Significant obesity, i.e., body mass index (BMI) at booking greater than 35 kg/m^2 9. Total daily insulin dose greater than 1.5 IU/kg at booking 10. Women who have conceived with in vitro fertilisation (IVF) or assisted reproductive techniques
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent with plasma glucose concentration in the target range (3.5 - 7.8 mmol/L) between 14.00 - 12.30 hours. Specific parameters will be the assessment of variability and frequency of mild and moderate hypoglycaemic events (plasma glucose less than 3.5 mmol/L and less than 2.8 mmol/L respectively), mild and moderate hyperglycaemic events (plasma glucose greater than 7.8 mmol/L and greater than 10.0 mmol/L respectively). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total daily dose of insulin (TDD) on intervention versus control visit 2. Actiheart physical activity energy expenditure (PAEE) score during the 24 hour study visit and 24 hour free living 3. Continuous blood glucose monitored (CGM) glucose levels during the 24 hour study visit and 24 hour free living | — |
Countries
United Kingdom
Outcome results
None listed