Ignite Creation Date:
2024-05-05 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00605839
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2008-01-17
Brief Title:
Mobile Communication Technology for Adolescents With Diabetes
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Among those with type I diabetes adolescents can be among the worst at achieving glycemic control Behaviors normal in adolescent development eg 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None