Mobile Communication Technology for Adolescents With Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): GlucoPak; Cell Phone; Usual Care
Intervention type(s): Device; Device; Other
Intervention description(s): We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.; We will provide cell phones and access to the clinic to facilitate communications; This intervention was usual care, without either device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: mobile technology; cell phones; type 1 diabetes