This trial is active, not recruiting.

Condition type 1 diabetes mellitis
Sponsor Washington University School of Medicine
Collaborator National Institutes of Health (NIH)
Start date January 2003
End date March 2006
Trial size 187 participants
Trial identifier NCT00916838, 02-1012, R01DK064832


125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study.

Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (Test 1) and after two years of close monitoring for blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. The 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device.

Children 7 and older also underwent high resolution MRI scans.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Children with Type 1 Diabetes Mellitis (T1DM) between 4 and 16 were recruited.
62 healthy siblings also enrolled in the study between the ages of 4 and 17.

Eligibility Criteria

Male or female participants from 4 years up to 16 years old.

Inclusion Criteria: - Age 4 - 16 (for MRI, must be 7 or older) Exclusion Criteria: - Pregnant or lactating (females 13+) - Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis. (Exclude for hypothyroidism) - Other current serious medical illness - Co-morbid psychiatric illness: such as mania, ADHD, LD, major depression, mental retardation, or psychoactive drug dependence - Co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness - EXCEPT T1DM-related - Pre-maturity at birth >4 wks early (<36 wk term) w/ sequelae e.g. on respirator at NICU - Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) or pts. w/recent tx w/dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall - Contraindication to MRI scan (e.g. claustrophobia, metal implants, foreign bodies) - N/A if < 4 years old - Full set (top and bottom) orthodontic braces. (Half set braces, fillings, and retainers are OK)

Additional Information

Official title Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Principal investigator Tamara G Hershey, PhD.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.