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

Type 1 Diabetes Clinical Trial

Official title:

Understanding Patient and Provider Glucose Reporting Preferences in Type 1 Diabetes: Cloud Based Ambulatory Glucose Profile (AGP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074384
• Other study ID #: 04356-14-A
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: November 30, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Type 1 Diabetics

Exclusion Criteria:

• Less than the age of 7

• Non-English Speaker

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Continuous Glucose Monitor
CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.
• Self Monitoring Blood Glucose
Participants will use their own SMBG device.

Other:
• Clinician
Survey of clinicians after study visits

Locations

Country	Name	City	State
United States	St. Vincent's	Billings	Montana
United States	Henry Ford	Detroit	Michigan
United States	Park Nicollet International Diabetes Center	Minneapolis	Minnesota
United States	Eda Cengiz	New Haven	Connecticut
United States	Columbia University	New York City	New York
United States	The Diabetes Center, PLLC	Ocean Springs	Mississippi
United States	Larry Deeb	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No