Type 1 Diabetes Clinical Trial
Official title:
Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
Among those with type I diabetes, adolescents can be among the worst at achieving glycemic
control. Behaviors normal in adolescent development (e.g., developing independence, rejecting
parental norms in favor of peers) can be at odds with the demands of effective diabetes
self-management. Modifying the family and patient interaction should be a crucial component
to improving the ability of an adolescent to manage his or her diabetes.
Mobile technology is becoming more popular in medicine, and adolescents, as a group are more
inclined to accept technology as an adjunct to care. Mobile technology that links adolescents
to health providers could help them to work through complex information that must be
processed to make good decisions. Since this "assistance" comes from health professionals, it
should help relax parents somewhat, thus reducing problems associated with parental
hypervigilance and manipulation of the regimen to avoid problems of hypoglycemia.
Parental-child conflicts may therefore be reduced by using cell phone glucose monitoring
technology that directly reports self-blood glucose monitoring data to providers and creates
a communication link to discuss therapeutic options.
This study investigates whether the use of mobile technology, in the form of a cell phone
glucose monitoring system, will help reduce the need for parents to assert behavioral
control, which can negatively impact adolescent diabetes self-management. The study will also
determine whether adolescents report improved quality of life, demonstrate competence in
diabetes management, and are able to achieve better control of their diabetes.
Among patients with type I diabetes, adolescents struggle the most with self-management,
which often results in poor glycemic control. Optimizing parent-patient interaction is
crucial to improving self-management. Mobile technology with integrated glucose monitoring
capability that links adolescents to providers may reduce parental hypervigilance and assist
them to better understand self-management. .
This study will investigate a novel cell phone glucose monitoring system (CPGM) with the
following specific aims:
1. To establish feasibility of a CPGM system as a component of an adolescent diabetes
management program.
2. To determine if the technology will improve a) quality of parent-child relationship, b)
patient quality of life, c) competence in diabetes management, and d) metabolic control.
3. To gather preliminary data for development of future intervention studies.
120 adolescents with type I diabetes will be randomly assigned to either an experimental or
control group. Experimental subjects will use the CPGM which will transmit all blood glucose
data to a host computer. A nurse practitioner in the pediatric endocrinology clinic will
determine need for telephone contacts based on evaluation of transmitted data. Subjects might
be telephoned to discuss possible regimen adjustments, need for clinic visits, or referrals
to additional services. Subjects will also be able to initiate contact with the project
nurse. Control subjects will continue to receive standard care. .
This study will assess the effect of the intervention in the four primary domains stated in
the specific aims. These domains will be measured at baseline, three months, and six months.
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