Evaluation of a tool to predict technology usage in youth with type 1 diabetes.
- Conditions
- Metabolic and Endocrine - DiabetesType 1 diabetes mellitus
- Registration Number
- ACTRN12611001043921
- Lead Sponsor
- The Royal Childrens Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients will be considered eligible if they are :
-Over the age of 8yrs
-Have a diagnosis of Type 1 Diabetes Mellitus
-Have been using a Medtronic insulin pump compatible with the MiniLink CGM device for >6mths (CGM arm of study)
-Home computer with e-mail access
-English language comprehension
Exclusion Criteria
-Previous self-initiated use of a continuous glucose monitoring system (this does not exclude clinician initiated previous short term use of one sensor to elucidate glycaemic patterns)
-Concurrent dermatological disorder e.g. keloid propensity or previous documented hypersensitivity to medical adhesives
-Impaired vision such that the user would be unable to read the CGM data
-Other medical condition or use of a medication that in the judgement of the investigator could affect wearing of a CGM sensor on a daily basis
-Pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the questionnaire (Qp) to predict low usage of technology (2 types being assessed in two arms - insulin pump and continuous glucose monitoring)<br>Low usage in the CGM arm will be usage of <70% as downloaded from the device. Low usage in the CSII arm will be designated as <5 blood glucose levels entered into the pump per day.[3 months for continuous glucose monitoring (CGM) arm.<br><br>6 months for continuous subcutaneous insulin infusion (CSII) arm.]
- Secondary Outcome Measures
Name Time Method