Mobile Communication Technology for Adolescents With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier:
NCT00605839
First received: January 17, 2008
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: GlucoPak
Device: Cell Phone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Quality of Parent-child Relationship [ Time Frame: Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Competence in Diabetes Management [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Metabolic Control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucopak Care
Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
Device: GlucoPak
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
Active Comparator: 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.
Device: Cell Phone
We will provide cell phones and access to the clinic to facilitate communications
Placebo Comparator: Usual Care
Usual care, without cell phone or glucopak

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

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605839

Locations
United States, Indiana
Riley Hospital Diabetes Clinics
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: David G Marrero, PhD Indiana University School of Medicine
Study Director: Aaron E Carroll, MD, MS Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Aaron Carroll, Assoc. Prof of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT00605839     History of Changes
Other Study ID Numbers: ADA-HenryBecton-DGM-01
Study First Received: January 17, 2008
Results First Received: September 12, 2012
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
mobile technology
cell phones
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014