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Sponsored by: |
Indiana University |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00605839 |
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 |
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Type 1 Diabetes |
Device: GlucoPak device and intensive monitoring |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes |
Estimated Enrollment: | 120 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Glucopak cell phone and intensive monitoring
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Device: GlucoPak device and intensive monitoring
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
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2: Active Comparator
Cell phone only
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Device: GlucoPak device and intensive monitoring
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
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3: Placebo Comparator
Usual care
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Device: GlucoPak device and intensive monitoring
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
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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:
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.
Ages Eligible for Study: | 14 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
Riley Hospital Diabetes Clinics | |
Indianapolis, Indiana, United States, 46202 |
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: | Indiana University School of Medicine ( David G. Marrero, PhD ) |
Study ID Numbers: | ADA-HenryBecton-DGM-01 |
Study First Received: | January 17, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00605839 |
Health Authority: | United States: Institutional Review Board |
mobile technology cell phones type 1 diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |