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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Continuous Glucose Monitor; Device: Self Monitoring Blood Glucose; Other: Clinician

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Eda Cengiz
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Larry Deeb
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Park Nicollet International Diabetes Center
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • The Diabetes Center, PLLC
  • Montana
    • Billings, Montana, United States, 59101
      • St. Vincent's
  • New York
    • New York City, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 1 Diabetics

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Glucose Monitoring; Participants will wear Continuous Glucose Monitoring for two weeks.	Device: Continuous Glucose Monitor; CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.; Other Names: Dexcom G4 professional version Continuous Glucose Monitor
Other: Self Monitoring Blood Glucose; Participants will self test for two weeks.	Device: Self Monitoring Blood Glucose; Participants will use their own SMBG device.
Other: Clinicians; Clinicians completing study visits.	Other: Clinician; Survey of clinicians after study visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
• Investigators: Principal Investigator: Richard Bergenstal, MD, Park Nicollet; Principal Investigator: Deborah Mulllen, PhD, Park Nicollet

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Estimate): March 28, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 04356-14-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No