None listed
Conditions
Brief summary
There are currently very few criteria to guide as to which youth would benefit most from using more advanced diabetes technologies, for example continuous subcutaneous insulin infusion (CSII). The lack of robust selection criteria means that intermittently, patients who may not benefit are commenced on CSII and subsequently encounter disappointment and regimen disruption if they elect to switch back to injected insulin. The ability to reliably predict lower self-care, as extrapolates to technology usage, would be helpful when advising an individual regarding their regimen. The purpose of this study is to see if this questionnaire can accurately predict which individuals will be most likely to use technology so that they gain the most benefit from it for their diabetes control. We wish to explore its ability to predict use of the two most commonly used technologies presently - continuous glucose monitoring (CGM) and CSII. Studies have shown that individuals get a clinically significant improvement in their HbA1c from usage of CGM when they use it 70% of the time, which equates to 5 days in any week. From CSII, most clinical benefit is gained when users enter 5 or more blood glucose measurements in their pump per day. Our hypothesis is that our questionnaire will predict individuals who will/will not display this usage of their device. Usage of CGM will be assessed after three months, as usage at this point has previously been shown in studies to be predictive of medium to long term usage. Likewise, usage of CSII at six months after commencement has been shown to be indicative of medium term usage.
Interventions
Assessment of the ability of our questionnaire to predict users who will demonstrate recommended usage of their diabetes technology. This questionnaire is a composite of the most-weighted items from previously validated questionnaires widely used in the diabetes literature. Each of these questionnaires was designed to assess various individual characteristics e.g. family conflict/self-efficacy/personality factors that we have identified as having a robust reproducible impact on HbA1c or self-car
Assessment of the ability of our questionnaire to predict users who will demonstrate recommended usage of their diabetes technology. This questionnaire is a composite of the most-weighted items from previously validated questionnaires widely used in the diabetes literature. Each of these questionnaires was designed to assess various individual characteristics e.g. family conflict/self-efficacy/personality factors that we have identified as having a robust reproducible impact on HbA1c or self-care. The questionnaire is designed to be completed by participants within 20-30 minutes. To show that this questionnaire is applicable to different kinds of diabetes technology, we will assess its ability to predict recommended usage of CGM after 3 months usage, and usage of CSII at 6 months after commencing. Usage of these technologies at these timepoints has been shown to be predictive of medium to long term usage. 50 Participants already using a CGM-compatible pump will be recruited to the CGM arm, where they will be provided with and shown how to use CGM for 3 months, after completing the questionnaire. Usage of >70% will be designated appropriate usage of CGM as this is the usage demonstrated to result in a clinically significant benefit of reduction in HbA1c of 0.5%. This can be downloaded from the device directly. After three months, the device will be returned and the participant's involvement in the study complete. 50 patients about to begin using insulin pump therapy (CSII) will also be recruited and asked to complete the questionnaire 6 weeks prior to starting the CSII 'pumpstart' program at our institution. Usage will be assessed from a pump download after 6 months and recommended usage will be designated as having >5 self-monitored blood glucose readings per day entered into the pump. This download will be assessed at a participant's routine outpatient appointment, which are scheduled every 3 months. After completing the questionnaire, participants in the CSII arm need not have any further contact with the study team. These arms are independent of each other, but both are necessary to show that the questionnaire can apply to various types of advanced diabetes technology. The sensitivity and specificity of our questionnaire to predict usage will be our primary outcome.
Sponsors
The Royal Childrens Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
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
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
Outcome results
None listed