Long Term Effects of Diabetes of Very Young Children

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

Juvenile Diabetes Research Foundation

Registry information

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: Jul 1, 2008
Registry last updated: Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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