Type 1 DiabetesNCT00707629
Long Term Effects of Diabetes of Very Young Children
An observational study of Type 1 Diabetes, run by Indiana University at 1 site in United States.
Trial summary
To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between ages 6 and 10. Diagnosed with type 1 diabetes prior to the age of 5 years.
Who may be able to join
- Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years
- Children recruited on pumps must have used pump therapy for at least 3 years
- Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years.
Who cannot join
- Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase.
- Children must not have any other chronic illness in addition to diabetes with the exception of treated autoimmune hypothyroidism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life.
It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, neurocognitive measures, behavioral measures
- Medical subject headings
- Diabetes Mellitus, Type 1
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 |
|---|---|---|
| Insulin Pump Therapy | Children on insulin pumps for at least three years. Subjects must have type 1 diabetes for at least five years and diagnosed under the age of 5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Control
HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar
Measured: Data Collected at each study visit
Ease of Injections versus Insulin pump Therapy
Mechanical issues, site infections and errors of insulin administration
Measured: Conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Linda DiMeglio, MD, Indiana University
- Investigators
- Linda A DiMeglio, MD, Principal investigator, Indiana University/Riley Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707629
- Sponsor's protocol ID
- 0507-18
- Status last verified
- Feb 2016
- First submitted
- 30 Jun 2008
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Diabetes of Very Young Children
- ClinicalTrials.gov ID
- NCT00707629
- Acronym / sponsor ID
- 0507-18
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, neurocognitive measures, behavioral measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Aug 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 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.
To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life.
It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin Pump Therapy | – | –Children on insulin pumps for at least three years. Subjects must have type 1 diabetes for at least five years and diagnosed under the age of 5. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between ages 6 and 10. Diagnosed with type 1 diabetes prior to the age of 5 years.
Key inclusion criteria (3 listed)
- Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years
- Children recruited on pumps must have used pump therapy for at least 3 years
- Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years.
Key exclusion criteria (2 listed)
- Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase.
- Children must not have any other chronic illness in addition to diabetes with the exception of treated autoimmune hypothyroidism.
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
Diabetes Control
Time frame: Data Collected at each study visit
HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar
Ease of Injections versus Insulin pump Therapy
Time frame: Conclusion of study
Mechanical issues, site infections and errors of insulin administration
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 1 Mar 2016.
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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.
Linda A DiMeglio, MD principal investigator
Indiana University/Riley Hospital for Children
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 Type 1 Diabetes, run by Indiana University 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 3 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 1 Mar 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?
Diabetes Control (time frame: Data Collected at each study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2016.