NCT02074384

Brief Summary

International Diabetes Center (IDC) proposes a preference and usability study of glucose data acquisition and reporting, evaluating streamlined standardized cloud-based glucose reporting including work flow as well as patient and clinician preference at Type 1 Diabetes (T1D) Exchange sites to enhance standard Ambulatory Glucose Profile (AGP) reporting. This phase 2 project assesses the efficacy of standardized glucose data report generation and preferred report presentation format; both are necessary to increase use of continuous glucose monitoring (CGM) data to improve care processes and outcomes for Type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

7 active sites

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

February 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 1, 2016

Completed
Last Updated

March 28, 2016

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

February 25, 2014

Results QC Date

September 10, 2015

Last Update Submit

February 29, 2016

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Portion of Study Participants Reporting Greater Utility From AGP vs. Traditional Glucose Data Reports

    Patients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.

    At the end of the two week SMBG or CGM period

Study Arms (3)

Continuous Glucose Monitoring

OTHER

Participants will wear Continuous Glucose Monitoring for two weeks.

Device: Continuous Glucose Monitor

Self Monitoring Blood Glucose

OTHER

Participants will self test for two weeks.

Device: Self Monitoring Blood Glucose

Clinicians

OTHER

Clinicians completing study visits.

Other: Clinician

Interventions

Continuous Glucose MonitorDEVICE

CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.

Also known as: Dexcom G4 professional version Continuous Glucose Monitor
Continuous Glucose Monitoring
Self Monitoring Blood GlucoseDEVICE

Participants will use their own SMBG device.

Self Monitoring Blood Glucose
ClinicianOTHER

Survey of clinicians after study visits

Clinicians

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 Diabetics

You may not qualify if:

  • Less than the age of 7
  • Non-English Speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Eda Cengiz

New Haven, Connecticut, 06511, United States

Location

Larry Deeb

Tallahassee, Florida, 32308, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

Park Nicollet International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

The Diabetes Center, PLLC

Ocean Springs, Mississippi, 39564, United States

Location

St. Vincent's

Billings, Montana, 59101, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Glucose Self-MonitoringNurse Clinicians

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesNurse SpecialistsNursesHealth PersonnelHealth Care Facilities Workforce and Services

Limitations and Caveats

This is a survey of patient and clinician preference and as such is subject to traditional survey biases (social desirability, hawthorne effect, etc.).

Results Point of Contact

Title
Dr. Deborah Mullen
Organization
Park Nicollet Institute
deborah.mullen@parknicollet.com
952-993-2070

Study Officials

  • Richard Bergenstal, MD

    Park Nicollet

    PRINCIPAL INVESTIGATOR

  • Deborah Mulllen, PhD

    Park Nicollet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 28, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 28, 2016

Results First Posted

January 1, 2016

Record last verified: 2015-10

Data Sharing

IPD Sharing
Will not share

Locations

US(7)