DPBRN Blood Sugar Testing in Dental Patients | NCT01201460

Studies
DPBRN Blood Sugar Testing in Dental Patients

NCT01201460

Sponsor

Dental Practice-Based Research Network

Status

Completed

Last Update Posted

Jun 16, 2011Estimated

Enrollment

498Actual

Phase

Not provided

Conditions

Diabetes Mellitus
Hyperglycemia

Interventions

Not provided

Countries

United States
Denmark

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
U01DE016747	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2011

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

Apr 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

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 14, 2011

Last Update Posted Date

Jun 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Dental Practice-Based Research NetworkNETWORK

Collaborators

Name	Class
National Institute of Dental and Craniofacial Research (NIDCR)	NIH
HealthPartners Institute	OTHER
Kaiser Permanente	OTHER
Permanente Dental Associates Group, Oregon

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 principal goal of this study was to assess the feasibility of plasma glucose testing in private dental practice. A second aim was was to assess prevalence of plasma glucose abnormalities in dental patients seen by (DPBRN) practitioner-investigators.

Detailed Description

The specific aims of this study were:

To quantify the percentage of (DPBRN) patients who meet the American Diabetes Association screening criteria and to describe the characteristics of these patients.
To quantify the acceptability of conducting glucose testing in the dental office and barriers to regular screening, as reported by (DPBRN) patients and practices.

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

498Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose testing		Patients participating in this study may be alerted to possible presence of (DM) or pre-(DM) or to inadequate glycemic control. In such a case, they were advised to follow-up with their physician for definitive diagnosis and treatment. Early diagnosis and improved glycemic control may be of significant benefit to the patients' health.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults over the age of 19 who were scheduled for a visit with an exam

Exclusion Criteria:

patients undergoing continuing treatment where an exam was not part of the visit were not eligible

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The human subjects direclty involved in this study were the patients who had sought dental treatment in the (DPBRN) practitioner-investigators' practices.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrei Barasch, DMD, MDSc	The University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
University of Florida College of Dentistry

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D006943	Hyperglycemia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided