Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes | NCT00916838

Studies
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

NCT00916838

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jun 18, 2018Actual

Enrollment

187Actual

Phase

Not provided

Conditions

Type 1 Diabetes Mellitis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK064832	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2018

Last Update Posted Date

Jun 18, 2018Actual

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type 1 Diabetes Mellitis		Children with Type 1 Diabetes Mellitis (T1DM) between 4 and 16 were recruited.
Non diabetic Control		62 healthy siblings also enrolled in the study between the ages of 4 and 17.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

125 children with Type 1 Diabetes Mellitus (T1DM) between 4 and 16 were recruited from the Diabetes Clinic at St. Louis Children's Hospital. 62 healthy siblings between 4 and 16 also enrolled in the study.

Sampling Method

Non-Probability Sample