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Mobile Communication Technology for Adolescents With Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GlucoPak
Cell Phone
Usual Care
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes focused on measuring mobile technology, cell phones, type 1 diabetes

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riley Hospital Diabetes Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Glucopak Care

Cell Phone Care

Usual Care

Arm Description

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

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.

Usual care, without cell phone or glucopak

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2008
Last Updated
September 11, 2017
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT00605839
Brief Title
Mobile Communication Technology for Adolescents With Diabetes
Official Title
Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: To establish feasibility of a CPGM system as a component of an adolescent diabetes management program. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
mobile technology, cell phones, type 1 diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucopak Care
Arm Type
Experimental
Arm Description
Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
Arm Title
Cell Phone Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual care, without cell phone or glucopak
Intervention Type
Device
Intervention Name(s)
GlucoPak
Intervention Description
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
Intervention Type
Device
Intervention Name(s)
Cell Phone
Intervention Description
We will provide cell phones and access to the clinic to facilitate communications
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
This intervention was usual care, without either device.
Primary Outcome Measure Information:
Title
Quality of Parent-child Relationship
Description
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.
Time Frame
Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Marrero, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aaron E Carroll, MD, MS
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Riley Hospital Diabetes Clinics
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mobile Communication Technology for Adolescents With Diabetes

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