Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes: Evaluation of Reduced Meal Bolusing
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Closed-loop insulin delivery, Post-prandial hypoglycaemia, Meal insulin dosing
Eligibility Criteria
Inclusion Criteria:
- The subject is between 12 and 18 years of age (inclusive).
- The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative.
- The subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment.
- HbA1c ≤ 12 % based on analysis from central laboratory
Exclusion Criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
- Known or suspected allergy against insulin
- Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician
- Total daily insulin dose >= 2 IU/kg
- Post-menarchal girls who are pregnant or intending to become pregnant or are breastfeeding
- Any coexisting cardiac and respiratory condition
Sites / Locations
- Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Closed-loop with standard meal insulin bolus
Closed-loop with reduced meal insulin bolus
Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard meal insulin dosing will be performed at each meal, following individual standard clinical practice.
Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. The standard meal insulin dose will be reduced by 20 to 50%.