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Ability to Cope With Type 1 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.
 
ClinicalTrials.gov Identifier: NCT00206362
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, MD, Baylor College of Medicine

Study Description
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Brief Summary:
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.

Condition or disease
Depression

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Ongoing Management of Type 1 Diabetes
Study Start Date : July 2004
Actual Primary Completion Date : February 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of diabetes clinic, Texas Children's Hospital.
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00206362


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine
More Information
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Responsible Party: Rubina Heptulla, MD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206362    
Other Study ID Numbers: 16040
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rubina Heptulla, MD, Baylor College of Medicine:
Depression
Socioeconomic status
Type 1 diabetes mellitus
Children
Adolescents
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Depression
Behavioral Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases