Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 Diabetes Mellitis

Children with Type 1 Diabetes Mellitis (T1DM) between 4 and 16 were recruited.

No interventions assigned to this group

Non diabetic Control

62 healthy siblings also enrolled in the study between the ages of 4 and 17.

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes