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

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.

Inclusion Criteria:

- Type 1 Diabetics

Exclusion Criteria:

- Less than the age of 7

- Non-English Speaker