Diabetes Research in Children Network (DirecNet) Outpatient Pilot Study to Evaluate the GlucoWatch® G2 TM Biographer in the Management of Type 1 Diabetes in Children Stuart A Weinzimer 1, Katrina Ruedy 2, Craig Kollman 2, Linda Larson 3, Jennifer Block 4, Jennifer Fisher 5, Elizabeth Boland 1, Keisha Bird 6, and the DirecNet Study Group 1 Dept of Pediatrics, Yale University School of Medicine, New Haven, CT; 2 Jaeb Center for Health Research, Tampa, FL; 3 Dept of Pediatrics, University of Iowa, Carver College of Medicine, Iowa City, IA; 4 Dept of Pediatrics, Stanford University, Stanford, CA; 5 Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver, CO, 6 Nemours Children’s Clinic, Jacksonville, FL

Background I Diabetes Research in Children Network (DirecNet) is a multi-center group investigating the use of non-invasive continuous glucose monitoring methods to optimize pediatric diabetes management

Background II Prior to conducting a large-scale outpatient trial of the GlucoWatch® G2 TM Biographer (GW2B), a pilot study was conducted to determine the feasibility of a “paperless” data acquisition and reporting system using computer data collection and electronic data transmission

Objective To determine the feasibility of using home personal computers (PC) for acquisition and transmission of glucose meter and GW2B data in an out-patient trial in children and adolescents with T1DM

Methodology I 15 subjects were provided with: –GW2B –One-Touch® UltraSmart TM blood glucose meter –Home PC (IBM-compatible, Windows XP-Pro OS) –Connection cables and software programs Subjects and families underwent a 2-hour training program on use of devices and procedures for data collection and storage and were instructed to use the GW2B at least twice weekly (day and night)

Methodology II UltraSmart meter and GW2B data were freely available for review by families to guide diabetes management UltraSmart meter data, GW2B downloads, and subject hypoglycemia questionnaires were uploaded to the DirecNet Coordinating Center on a weekly basis by modem data transfer. These data were made available to clinical center personnel via a secure password-encoded website

Methodology III Therapeutic decisions based on uploaded data were made by clinical center personnel and reviewed with subjects/families during scheduled telephone contact at weeks 1, 2, 4 and 8 Non-protocol telephone contacts initiated by subjects/families and problems with data collection/transmission were tracked

Methodology IV Data from baseline and 3-month visits, including HbA1c measurements, satisfaction questionnaires, physical examinations, skin assessments, and GW2B/UltraSmart review were collected at the Clinical Centers using a tablet PC and a web-based data collection form and transmitted to the Coordinating Center via a secure password-encoded website

Subject Demographics Gender F / M7 / 8 Age mean ± SD (y)12 ± 3 Race / Ethnicity N(%) White12 Hispanic or Latino1 African-American1 Other/Unknown1 Treatment modality MDI / pump7 / 8 HbA1c at study entry mean ± SD (%)7.4 ± 0.8

GW2B Use Declined Significantly* over Course of Study Week of Study # GWB wears per week * p < Box plots denote minimum, 25th percentile, median, 75th percentile and maximum values for each week

Ultra Meter Use Remained Constant over Course of Study Week of Study # Ultra use per day Box plots denote minimum, 25th percentile, median, 75th percentile and maximum values for each week

Protocol Telephone Contact with Clinical Centers Mean duration of call (min)

Non-Protocol Telephone Contact with Clinical Centers Total minutes per subject

Questionnaire Completion

Problems Encountered 3 subjects required replacement of hardware –error in UltraSmart software – hard drive replaced –incorrect initial date/time setting – hard drive replaced –modem malfunction – PC replaced severe storms caused failure of the automatic download procedure for 10 subjects on one day –data were successfully retrieved by dialup to home PC modems from Coordinating Center

Conclusions There was a significant decline in GW2B use over the course of the study It is feasible to conduct a clinical study of diabetes management using a “paper-less” data capture and reporting system using computer data collection and electronic data transmission

Barbara Davis Center –H. Peter Chase –Rosanna Fiallo-Scharer –Jennifer Fisher –Barbara Tallant University of Iowa –Eva Tsalikian –Michael Tansey –Linda Larson –Julie Coffey –Amy Sheehan Nemours Children’s Clinic –Tim Wysocki –Nelly Mauras –Keisha Bird –Kelly Lofton Stanford University –Bruce Buckingham –Darrell Wilson –Jennifer Block –Paula Clinton Yale University –William Tamborlane –Stuart Weinzimer –Elizabeth Boland –Kristin Sikes –Amy Steffen Jaeb Center for Health Research –Roy Beck –Katrina Ruedy –Craig Kollman –Dongyuan Xing –Cynthia Silvester

Abstract Diabetes Research in Children Network (DirecNet) Outpatient Pilot Study to Evaluate the GlucoWatch® G2 TM Biographer (GW2B) in the Management of Type 1 Diabetes (T1DM) in Children. Stuart Weinzimer 1, Katrina Ruedy 2, Linda Larson 3, and the Diabetes Research in Children Network (DirecNet) Study Group. 1 Department of Pediatrics, Yale University School of Medicine, New Haven, CT; 2 Jaeb Center for Health Research, Tampa, FL; 3 Department of Pediatrics, University of Iowa, Carver College of Medicine, Iowa City, IA. DirecNet is an NIH-sponsored multi-center group that is evaluating use of glucose sensors in children. Prior to conducting a randomized trial to assess the efficacy of the GW2B to improve glycemic control, a 3-month pilot study was conducted to assess the feasibility of using PCs in the home for computer- based data acquisition and transmission. Fifteen subjects with T1DM (age range years) were provided with a GW2B and a OneTouch Ultra® meter (“Ultra”) along with a personal computer (“PC”) and software for downloading glycemic data for each device. The PC was also used weekly to complete a questionnaire regarding hypoglycemia and problems with using the GW2B. Patients were able to view Ultra and GW2B data at any time on the PC. Each week, the data were downloaded to the study coordinating center and made available to the clinical centers on a secure website. Therapeutic changes were based on the downloads, hypoglycemia questionnaires, and telephone contacts with clinical centers. Quality of life, diabetes self-management behaviors and satisfaction with GW2B use were measured periodically. GW2B use ranged from weekly at the beginning of the study and weekly by study end. Patients averaged 6 daily Ultra readings and completed the hypoglycemia questionnaires 83% of the time. While this study did not allow for formal assessment of the effectiveness of the GW2B, one patient had a drop in HbA1c from 8.6 to 7.3 over the 3-month study period. This pilot study demonstrated the feasibility of using PCs in the home to download GW2B and Ultra data, collecting GW2B and diabetes-related information on a weekly basis, and transferring data electronically to a central center.