Mobile Communication Technology for Adolescents With Diabetes

NCT00605839 | Completed Results

• 1 other identifier: ADA-HenryBecton-DGM-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

mobile technology; cell phones; type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Quality of Parent-child Relationship

  The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children's perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.

  Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.

Study Arms (3)

Glucopak Care

EXPERIMENTAL

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

Device: GlucoPak

Cell Phone Care

ACTIVE COMPARATOR

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.

Device: Cell Phone

Usual Care

PLACEBO COMPARATOR

Usual care, without cell phone or glucopak

Other: Usual Care

Interventions

GlucoPak DEVICE

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

Glucopak Care

Cell Phone DEVICE

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

Cell Phone Care

Usual Care OTHER

This intervention was usual care, without either device.

Usual Care

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital Diabetes Clinics

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

This was a small pilot study to generate results for further work.

Results Point of Contact

• Title: Aaron E. Carroll
• Organization: Indiana University School of Medicine

aaecarro@iupui.edu

3172780552

Study Officials

• David G Marrero, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Aaron E Carroll, MD, MS

  Indiana University School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof of Pediatrics

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 31, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 11, 2017
• Results First Posted: November 20, 2013

Record last verified: 2017-09

Locations

US (1)