Glucose Control Using 1,5-AG: Randomized Controlled Trial
Phase: NA
Conditions: Diabetes
Sponsor: Qure Healthcare, LLC



• 
Clinical Study Protocol
1ly of\/lark 
Title: The GLUCAR Clinical Utility Trial: GLUcose Control using 1,5-AG Randomized 
Controlled Trial 
Document Number: 
Supersedes: 
I
Effective Date: 
Page: 18 of 23
subject's identity. The subject's name or other identifying information will not be used in analysis 
or reporting. 
The main study procedures or assessments will include but are not limited to: collection of 
demographic and practice information during the screening process and completion of CPVs. 
6.1 
Pre-Screening and Eligibility 
The evaluations for inclusion and exclusion criteria will include board certification, 
practice type, patient volume and years in practice. 
6.2 
Completion of CPVs 
Enrolled physicians will be provided a unique website address to access the CPVs. Each 
CPV is expected to take approximately 15-20 minutes. Participants will be given 7 days to 
complete the CPVs. If the CPVs are not completed within this timefrarne, the physician will 
be contacted and requested to complete the CPVs. Physicians will be reminded to complete 
the CPVs by phone and/or emails. If after 10 business days, they still have not completed 
the CPV, they will be withdrawn from the study. 
7.
STUDY DATA COLLECTION
Data entry and resolution will be performed in real-time concurrent with CPV data collection. All 
data will be linked to physicians via a unique identification number; only the study team will have 
access to their identities. Electronic data files will be password protected. Periodic audits will ensure 
data protection procedures are being followed. No physician will be mentioned by name in any data 
output. 
8.
STATISTICALANALYSIS
8.1 Determination of Sample Size 
The study is adequately powered to detect differences in the combined diagnosis and treatment 
score as measured by the CPVs. A sample size of 75 physicians in each arm (150 total) provides 
over 80% power to detect an estimated 6-7% difference in scores with alpha=0.05 and discriminate 
differences in case and physician characteristics (age, gender, specialty, etc.). Due to possible 
attrition, an additional 10 physicians will be enrolled in each arm to ensure that at least 150