NCT01339208

Brief Summary

The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2011

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

April 1, 2011

Enrollment Period

3.8 years

First QC Date

April 14, 2011

Last Update Submit

May 26, 2015

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c % from baseline

    3 and 6 month

Secondary Outcomes (1)

  • Patient satisfaction

    6 month

Study Arms (1)

Telemedicine Diabetes Intervention

EXPERIMENTAL
Other: Telemedicine diabetes intervention

Interventions

Telemedicine diabetes interventionOTHER

3 month duration telemedicine consultation and diabetes education

Telemedicine Diabetes Intervention

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older with type 2 diabetes
  • Referral by a primary care provider.
  • HbA1c equal or greater than 7.0%.

You may not qualify if:

  • Type 1 diabetes
  • Gestational Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Northwest

Seneca, Pennsylvania, 16346, United States

Location

Related Publications (1)

  • Toledo FG, Ruppert K, Huber KA, Siminerio LM. Efficacy of the Telemedicine for Reach, Education, Access, and Treatment (TREAT) model for diabetes care. Diabetes Care. 2014 Aug;37(8):e179-80. doi: 10.2337/dc13-1909. No abstract available.

    PMID: 25061149DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Frederico Toledo, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Diabetes Institute

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 20, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 28, 2015

Record last verified: 2011-04

Locations

US(1)