DiabetesNCT00717223
A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes
An observational study of Diabetes and Type 1 Diabetes Mellitus, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to see if a patient's ability (and/ or parent) to read, write, and do basic math problems affects blood sugar control in children with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Diabetes, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with diabetes attending clinic followup at Texas Children's Hospital
Who may be able to join
- Type 1 or type 2 diabetes mellitus
- Parent/ legal guardian must be present if child is less than 18 years of age.
- Diagnosis of type 1 or type 2 diabetes mellitus must have been made at least 1 year earlier.
- Parent/ legal guardian and/ or child must have completed all 3 mandatory diabetes education classes.
- English and/or Spanish speaking only.
Who cannot join
- Any form of mental retardation or cognitive disorder in parent/ legal guardian.
- Mental retardation or cognitive disorder in a child who is in Grade 6 or higher.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes Clinic, Texas Children's Hospital
Houston, Texas, 77030
About this study
The purpose of this study is to see if a patient's ability (and/ or parent) to read, write, and do basic math problems affects blood sugar control in children with type 1 diabetes mellitus.
Read the detailed description
"Literacy" is defined as an individual's ability to read, write, and speak English, and compute and solve problems at levels of proficiency necessary to function on the job and in society, to achieve one's goals, and develop one's knowledge and potential, according to the National Literacy Act of 1991. The National Work Group on Health and Literacy reported that between 40 and 44 million persons in the United States have rudimentary literacy skills, and are unable to understand written materials that require only basic reading proficiency. Illiteracy has become an increasingly important problem, especially as it relates to healthcare. Literacy skills are paramount to effective self-management of type 1 and type 2 diabetes mellitus. And, "Diabetes Self-Management Education" is the cornerstone of care for all individuals with diabetes who want to achieve successful health-related outcomes. Self care of diabetes plays a major role in achieving DCCT recommended level of hemoglobin A1C. Deficient self-management will lead to uncontrolled diabetes, resulting in multisystem complications, increasing exponentially the burden on our healthcare system. Structured education of individuals tailored to combat poor literacy skills is imperative in helping these individuals achieve good glycemic control. Hence we would like to evaluate literacy in our clinic so appropriate educational material can be developed to help patient with T1DM who have low literacy.
- Conditions
- Diabetes, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Type 1 diabetes mellitus, Type 2 diabetes mellitus, Literacy, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents with children with diabetes | parents who have children 18 or younger with diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Literacy levels and HbA1c
look at literacy levels an HbA1c
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubina Heptulla, MD, Baylor College of Medicine
- Investigators
- Rubina A Heptulla, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717223
- Sponsor's protocol ID
- H-21263
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2008
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hassan K, Heptulla RA. Glycemic control in pediatric type 1 diabetes: role of caregiver literacy. Pediatrics. 2010 May;125(5):e1104-8. doi: 10.1542/peds.2009-1486. Epub 2010 Apr 5.
PubMed 20368322
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes
- ClinicalTrials.gov ID
- NCT00717223
- Acronym / sponsor ID
- H-21263
- Conditions
- Diabetes, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Type 1 diabetes mellitus, Type 2 diabetes mellitus, Literacy, Glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if a patient's ability (and/ or parent) to read, write, and do basic math problems affects blood sugar control in children with type 1 diabetes mellitus.
Detailed description
"Literacy" is defined as an individual's ability to read, write, and speak English, and compute and solve problems at levels of proficiency necessary to function on the job and in society, to achieve one's goals, and develop one's knowledge and potential, according to the National Literacy Act of 1991. The National Work Group on Health and Literacy reported that between 40 and 44 million persons in the United States have rudimentary literacy skills, and are unable to understand written materials that require only basic reading proficiency. Illiteracy has become an increasingly important problem, especially as it relates to healthcare. Literacy skills are paramount to effective self-management of type 1 and type 2 diabetes mellitus. And, "Diabetes Self-Management Education" is the cornerstone of care for all individuals with diabetes who want to achieve successful health-related outcomes. Self care of diabetes plays a major role in achieving DCCT recommended level of hemoglobin A1C. Deficient self-management will lead to uncontrolled diabetes, resulting in multisystem complications, increasing exponentially the burden on our healthcare system. Structured education of individuals tailored to combat poor literacy skills is imperative in helping these individuals achieve good glycemic control. Hence we would like to evaluate literacy in our clinic so appropriate educational material can be developed to help patient with T1DM who have low literacy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents with children with diabetes | – | –parents who have children 18 or younger with diabetes |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with diabetes attending clinic followup at Texas Children's Hospital
Key inclusion criteria (5 listed)
- Type 1 or type 2 diabetes mellitus
- Parent/ legal guardian must be present if child is less than 18 years of age.
- Diagnosis of type 1 or type 2 diabetes mellitus must have been made at least 1 year earlier.
- Parent/ legal guardian and/ or child must have completed all 3 mandatory diabetes education classes.
- English and/or Spanish speaking only.
Key exclusion criteria (2 listed)
- Any form of mental retardation or cognitive disorder in parent/ legal guardian.
- Mental retardation or cognitive disorder in a child who is in Grade 6 or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Literacy levels and HbA1c
Time frame: 1 year
look at literacy levels an HbA1c
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 20368322Hassan K, Heptulla RA. Glycemic control in pediatric type 1 diabetes: role of caregiver literacy. Pediatrics. 2010 May;125(5):e1104-8. doi: 10.1542/peds.2009-1486. Epub 2010 Apr 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubina A Heptulla, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Type 1 Diabetes Mellitus, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Literacy levels and HbA1c (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00717223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.