Reversal of Hypoglycemia Unawareness Using Continuous Glu... | NCT00796848

Studies
Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

NCT00796848

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Jun 6, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Navigator Continuous Glucose Monitor

Countries

United States

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
Stanford eprotocol #14728	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

withdrawn because the research efforts at that time followed another path

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Oct 23, 2008

First Submission Date that Met QC Criteria

Nov 21, 2008

First Posted Date

Nov 24, 2008Estimated

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 1, 2018

Last Update Posted Date

Jun 6, 2018Actual

Name	Class
University of Colorado, Denver	OTHER

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

The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think that your body may not have enough of a certain hormone that usually helps people know when they are going low. If you can keep from going low, we think there will be enough of that hormone to help you recognize the symptoms of a low before it happens.

Detailed Description

To enroll in this study you must be between the ages of 7 and 20, have type 1 diabetes, and experience at least two episodes of low blood glucose readings weekly that you do not feel. Up to 25 subjects will be enrolled at Stanford and another 25 at the Barbara Davis Center in Colorado. The study will last approximately 8 months for each participant.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Navigator Continuous Glucose Monitor	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.

Secondary Outcomes

Measure	Description	Time Frame
To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be at least 7 to 20 years old
Have been diagnosed with type 1 diabetes for at least 1 year
Report 2 or more episodes per week of asymptomatic hypoglycemia as determined by completion of the Hypoglycemia Awareness Questionnaire (HAQ) or as determined by Investigator
HbA1c level < 10%
Internet access for downloading continuous glucose monitoring (CGM), access to a compatible computer (Windows Vista is not compatible for downloading.)
For females, you are not intending to become pregnant during the study
No expectation that you will be moving out of the area for the duration of the study

Exclusion Criteria:

The presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the Investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
Treatment with systemic or inhaled corticosteroids in the last six months
Inpatient psychiatric treatment in the past six months for you or your primary caregiver
Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the Investigator would be a contraindication to participation in the study
Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment
Having a severe hypoglycemic episode in the 30 days prior to enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases