Expired Study
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Houston, Texas 77030


Purpose:

The purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. In addition to this, we will study the effect of type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.


Study summary:

Coping with type 1 diabetes can be very difficult. Type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. Several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. This may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or "burnout," after a certain period of time due to an overwhelming amount of responsibility. In our study we would like to determine how children's ability to cope with diabetes affects glucose control. By completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. These scores will then be analyzed in comparison to your glucose control using HbA1c.


Criteria:

Inclusion Criteria: - Subjects must be type 1 diabetic - English/spanish speaking - The legal guardian must be present. Exclusion Criteria: - Non-cognitive or mentally ill - Under the age of 8.0 years


Study is Available At:


Original ID:

16040


NCT ID:

NCT00206362


Secondary ID:


Study Acronym:


Brief Title:

Ability to Cope With Type 1 Diabetes


Official Title:

Evaluation of Ongoing Management of Type 1 Diabetes


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

8 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor College of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

100


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rubina A Heptulla, MD
Principal Investigator
Baylor College of Medicine

Study Dates

Start Date:July 2004
Completion Date:April 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 19, 2016
First Received Date:September 14, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Texas Children's Hospital

Samples and Retentions

Study Population: Patients of diabetes clinic, Texas Children's Hospital.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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