Topic: Diabetes Research Network, Medicines for Children Research Network
Conditions
Interventions
Primary Intervention, Sensor insertion for the Continuous Glucose monitor (CGM)
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Between the ages of 6 and 18 years 2. Have Type 1 diabetes, as defined by WHO criteria for at least 1 year or is confirmed Cpeptide negative 3. Be an insulin pump user for at least 3 months, with a good knowledge of insulin dose adjustment 4. HbA1c between below 11 % based on analysis from central laboratory 5. Literate in English 6. Willing to undertake all study related activities
Exclusion criteria
Exclusion criteria: 1. Nontype 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 3. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, nonselective betablockers and MAO inhibitors 4. Known or suspected allergy against insulin 5. Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 6. Patient is pregnant, or breast feeding during the period of the study 7. Total daily insulin dose = 2 Units/kg/day 8. Total daily insulin dose < 10 Units/day 9. Severe visual impairment 10. Severe hearing impairment 11. Subjects using implanted internal pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome; Timepoint(s): The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed