Mobile Communication Technology for Adolescents With Diabetes

NCT ID: NCT00605839

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Type 1 Diabetes

Keywords

mobile technology; cell phones; type 1 diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Glucopak Care

Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.

Group Type: EXPERIMENTAL

GlucoPak

Intervention Type: DEVICE

We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.

Cell Phone Care

Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.

Group Type: ACTIVE_COMPARATOR

Cell Phone

Intervention Type: DEVICE

We will provide cell phones and access to the clinic to facilitate communications

Usual Care

Usual care, without cell phone or glucopak

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

This intervention was usual care, without either device.

Interventions

GlucoPak

We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.

Intervention Type: DEVICE

Cell Phone

We will provide cell phones and access to the clinic to facilitate communications

Intervention Type: DEVICE

Usual Care

This intervention was usual care, without either device.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Aaron Carroll

Assoc. Prof of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David G Marrero, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Aaron E Carroll, MD, MS

Role: STUDY_DIRECTOR

Indiana University School of Medicine

Locations

Riley Hospital Diabetes Clinics

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

ADA-HenryBecton-DGM-01

Identifier Type: -

Identifier Source: org_study_id