Topic: Diabetes
Conditions
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
University of Cambridge (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 18 and 45 years of age (inclusive) 3. The participant has type 1 diabetes (T1D), as defined by WHO for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound at gestational age = 8 and = 24 weeks 4. The participant is using intensive insulin therapy (at least three or more daily injections or insulin pump therapy) and compliant with diabetes self-management i.e. doing =4 SMBG tests per day 5. The participant is able and willing to use the study devices and has completed the CGM run-in assessment 6. The participant is able to speak and understand English 7. The participant has access to email
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 MAO inhibitor 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 good or very poor glycaemic control i.e. HbA1c =6.5% at booking (48 mmol/mol) or baseline HbA1c =10% (86 mmol/mol) 8. Significant obesity i.e. Body Mass Index (BMI) at booking > 35 kg/m2 9. Total daily insulin dose >/= 1.5 IU/kg at booking 10. Women who have conceived with IVF or assisted reproductive techniques
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 29/04/2016: The primary outcome is the percentage time spent with glucose levels = 63mg/dl and ?140mg/dl (3.5 and ? 7.8mmol/l), as recorded by continuous glucose monitoring (CGM) during the 28 day intervention periods. Previous primary outcome measures: 1. The primary efficacy outcome is the overnight time spent in the target glucose range from 3.5-7.8 mmol/L, as recorded by continuous glucose monitoring (CGM) adjusted for sensor error during the 28-day intervention periods. 2. Safety evaluation will comprise number of episodes of nocturnal hypoglycaemia, the duration and outcome of those events as well as the number of subjects experiencing severe hypoglycaemia. The closed-loop intervention arm will be compared with the continuous glucose monitoring without closed-loop intervention arm. All subjects including those who withdraw will be included in the safety evaluation. 3. Utility evaluation is the frequency and duration of use of the closed-loop system as compared to the use of real-time CGM without the closed-loop system, and the users? responses in terms of lifestyle change and diabetes self-management. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/04/2016: 1. The overnight time with glucose levels in the hypoglycaemic range, based on continuous glucose monitoring (glucose levels 140mg/dl or 7.8mmol/L). 3. The overall time (day and night) with glucose levels in the hypoglycaemic range, based on continuous glucose monitoring (glucose levels 140mg/dl or 7.8mmol/L). 5. Metabolic control assessed by change in HbA1c after the use of closed-loop for 28 days, compared with that during sensor augmented pump therapy for 28 days. HbA1c will be measured before and after each intervention arm 6. CGM data collected during intervention arms will also be compared to baseline CGM readings. 7. Trends in CGM data collected within intervention arms will also be evaluated on weekly basis. 8. Percentage time spent with CGM 140mg/dl (7.8mmol/l) to quantify the duration of hyperglycaemia 11. Percentage time spent at CGM > 180mg/dl (10.0 mmol/l) to quantify significant hyperglycaemia 12. Percentage time spent at CGM > 63mg/dl to ? 180mg/dl (3.5 to ? 10.0mmol/l) to quantify near optimal target range 13. Area under the curve (AUC) for glucose levels: 13.1. > 140mg/dl (7.8mmol/l) 13.2. > 120mg/dl (6.7mmol/l) 13.3. 7.8 mmol/L). 3. The overall time (day and night) with glucose levels in the hypoglycaemic range, based on continuous glucose monitoring (glucose levels 7.8 mmol/L). 5. Metabolic control assessed by change in HbA1c after the use of closed-loop system for 28 days, compared with that during continuous glucose monitoring without the closed-loop system for 28 days. HbA1c will be measured before and after each intervention arm. 6. CGM data collected during intervention arms will also be compared to baseline CGM readings. 7. Trends in CGM data collected within intervention arms will also be evaluated on weekly basis (i.e. week 1 versus week 2 versus week 3 versus week 4). | — |
Countries
United Kingdom
Outcome results
None listed