Mobile Communication Technology for Adolescents With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00605839
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : November 20, 2013
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Aaron Carroll, Indiana University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: GlucoPak Device: Cell Phone Other: Usual Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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
Other: Usual Care
This intervention was usual care, without either device.

Primary Outcome Measures :
  1. 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. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00605839

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

Responsible Party: Aaron Carroll, Assoc. Prof of Pediatrics, Indiana University Identifier: NCT00605839     History of Changes
Other Study ID Numbers: ADA-HenryBecton-DGM-01
First Posted: January 31, 2008    Key Record Dates
Results First Posted: November 20, 2013
Last Update Posted: October 11, 2017
Last Verified: September 2017

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

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