Patient and Provider Glucose Reporting Preferences Ambulatory Glucose Profile (AGP)

NCT ID: NCT02074384

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

Patient participation in diabetes treatment has relied upon episodic self-monitoring of blood glucose (SMBG). SMBG assists patients and clinicians with adjustments of insulin, identification of hypoglycemia, nutritional intake and activity in order to optimize diabetes control. SMBG however is subject to bias dependent upon the testing frequency and timing. In contrast, continuous glucose monitoring (CGM) systems capture continuous 24-hour glucose data uninterrupted and unbiased. It provides valuable information about daily/nightly alterations in glucose patterns. Unfortunately SMBG, CGM and insulin pump devices have proprietary software with unique data standards, acquisition methods, reports, and graphic displays. These differences make evaluation and comparison of SMBG or CGM data difficult for clinicians and patients. IDC created an Ambulatory Glucose Profile (AGP) report to reduce challenges of device specific reports through a standardized report which is produced from any device with streamlined graphic displays of glucose trends.

The phase 1 project (2012), gathered expert stakeholders (clinical, research, industry, patients) who validated data standards and recommended changes to the CGM-AGP reports. These changes are now integrated into a secure cloud-based infrastructure for AGP reporting.

Phase 2 of this project is a usability and preference study of glucose reporting systems. It will include an in depth study of 6 T1D Ex clinical sites. The T1D Exchange Clinic Network was formed to support the development of a large registry of adults and children with type 1 diabetes for the purpose of conducting multiple studies proposed by T1D Exchange investigators, and other researchers, patients, and companies.

The 6 sites will be selected for an in-depth study utilizing middleware data collection services (Diasend or SweetSpot) to facilitate efficient collection of data from diverse devices. These middleware solutions integrate with the captūrAGP system to automatically produce an AGP report. These sites will test the feasibility of AGP cloud reporting while collecting patient and clinician opinions on report preference. All 6 sites participating in phase 2 will collect patient and clinician preference measures. Two study sites will undergo time in motion (TIM) measurement and workflow mapping of current process. This TIM sub-study includes workflow mapping of current and cloud-based processes utilizing Toyota Lean (Kaizen) methodology. Sites 3 - 6 will receive enhanced designs through the adaptive trial method with learnings applied from sites 1 and 2.

A key deliverable of this study is patient and clinician insight into their utilization of CGM reporting technologies. Recognizing that adoption of technology is often stymied by time constraints, report reliability and ease of interpretation, these variables will be examined. The goal of phase 2 is to analyze the viability of standard reporting and to evaluate preference (patient and clinicians) for and perceived value of different types of glucose pattern reports (AGP vs. device) including clinical practice time saved.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitoring

Participants will wear Continuous Glucose Monitoring for two weeks.

Group Type: OTHER

Continuous Glucose Monitor

Intervention Type: DEVICE

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

Self Monitoring Blood Glucose

Participants will self test for two weeks.

Group Type: OTHER

Self Monitoring Blood Glucose

Intervention Type: DEVICE

Participants will use their own SMBG device.

Clinicians

Clinicians completing study visits.

Group Type: OTHER

Clinician

Intervention Type: OTHER

Survey of clinicians after study visits

Interventions

Continuous Glucose Monitor

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

Intervention Type: DEVICE

Self Monitoring Blood Glucose

Participants will use their own SMBG device.

Intervention Type: DEVICE

Clinician

Survey of clinicians after study visits

Intervention Type: OTHER

Other Intervention Names

Dexcom G4 professional version Continuous Glucose Monitor

Eligibility Criteria

Inclusion Criteria

• Type 1 Diabetics

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

Park Nicollet

Deborah Mulllen, PhD

Role: PRINCIPAL_INVESTIGATOR

Park Nicollet

Locations

Eda Cengiz

New Haven, Connecticut, United States

Larry Deeb

Tallahassee, Florida, United States

Henry Ford

Detroit, Michigan, United States

Park Nicollet International Diabetes Center

Minneapolis, Minnesota, United States

The Diabetes Center, PLLC

Ocean Springs, Mississippi, United States

St. Vincent's

Billings, Montana, United States

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

04356-14-A

Identifier Type: -

Identifier Source: org_study_id