NCT02497170

Brief Summary

Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

July 10, 2015

Last Update Submit

March 10, 2016

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Pre and Post Differences

    4 months

Study Arms (1)

Life style changes

OTHER

Pre and post after education intervention Education program

Behavioral: Education of goal setting and achievement

Interventions

Education of goal setting and achievementBEHAVIORAL

Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them

Life style changes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
  • Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
  • Patients who give written consent to participate

You may not qualify if:

  • Patients below age 18, children are not treated in the facility for type 2 diabetes
  • Patients who attend less than 4 monthly appointments for diabetes,
  • Patients who do no give written consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melissa Souza

Somerdale, New Jersey, 08083, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • melissa souza

    Rutgers University Newark New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 14, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations

US(1)