Clinical trial NCT00605839: Mobile Communication Technology for Adolescents With Diabetes
Official title: Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: mobile technology
cell phones
type 1 diabetes
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-01-31
Enrollment: 105
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Adolescent with thpe 1 diabetes
2. Adolescents in the study must intend to remain in the care of participating clinics for the extent of the study
3. Adolescents in the study must be literate in English.

Exclusion Criteria:

1. Only one patient per family can participate
2. Patients who participated in preliminary studies related to the development of the cell phone technology will be excluded.

Primary outcomes:
measure: Quality of Parent-child Relationship
timeFrame: Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital Diabetes Clinics
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: David G Marrero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Aaron E Carroll, MD, MS
role: STUDY_DIRECTOR
References: