Topic: Diabetes Research Network, Medicines for Children Research Network
Conditions
Interventions
1. Realtime CGM + overnight CL
2. Realtime CGM alone
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is between 6 and 18 years of age (inclusive) 2. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed Cpeptide negative 3. The subject will have been an insulin pump user for at least 3 months, with good knowledge of insulin selfadjustment as judged by theinvestigator. 4. The subject is willing to perform regular fingerprick blood glucose monitoring, with at least 4 blood glucose measurements taken every day 5. HbA1c = 10 % based on analysis from central laboratory or equivalent 6. The subject is literate in English
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy against insulin 2. Nontype 1 diabetes mellitus including those secondary to chronic disease 3. Untreated celiac disease 4. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator 5. Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, nonselective betablockers and MAO inhibitors etc 6. Known or suspected allergy against insulin 7. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 8. Total daily insulin dose = 2 IU/kg/day 9. Total daily insulin dose < 10 IU/day 10. Pregnancy, planned pregnancy, or breast feeding 11. Severe visual impairment 12. Severe hearing impairment 13. Subjects using implanted internal pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent overnight in the target glucose range (3.9 to 8.0 mmol/l) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed