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Diabetes Research in Children Network Pilot Study of the Navigator TM

Diabetes Research in Children Network Pilot Study of the Navigator TM Continuous Glucose Monitoring System in Children with Type 1 Diabetes: Safety, Tolerability, and Factors Associated with Use. Stuart A Weinzimer, MD for the Diabetes Research in Children Network Study Group 26 Oct 2007

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Diabetes Research in Children Network Pilot Study of the Navigator TM

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  1. Diabetes Research in Children Network Pilot Study of the NavigatorTM Continuous Glucose Monitoring System in Children with Type 1 Diabetes: Safety, Tolerability, and Factors Associated with Use Stuart A Weinzimer, MD for the Diabetes Research in Children Network Study Group 26 Oct 2007 New Haven, CT

  2. Background • Real-time continuous glucose monitoring devices (CGM) are a potentially powerful tool in the management of type 1 diabetes (T1D) • For successful adoption into clinical practice, however, they must be accurate, comfortable to wear, and easy to use, particularly in children • A previous-generation CGM, the GlucoWatch Biographer, failed to improve glycemic control in 200 children with T1D during a 6-mth trial

  3. Objectives • The aims of this pilot study were to examine the tolerability and effectiveness of a continuous glucose monitor (Abbott Navigator) in children with type 1 diabetes using intensive insulin regimens • CSII (insulin pump therapy) • Glargine-based multiple daily injection (MDI) • To identify demographic and/or clinical factors predictive of successful long-term use of CGM

  4. Study Design • Subjects wore the Navigator as an outpatient for 1 week but were blinded to sensor data in order to characterize “baseline” control • Subjects wore the Navigator (unblinded) as an outpatient for 13 weeks • Devices were downloaded weekly to subjects’ home computers and subjects were contacted frequently (q1-4wk) in order to monitor Navigator use • CGM Satisfaction questionnaires were completed at baseline and 13 weeks • Subjects then invited to continue use of Navigator for additional 13 weeks

  5. Outcome Measures • Glycemic control • Hemoglobin A1c • Mean glucose levels • Percentage of glucose values within, above, or below target • Glycemic variability • Mean amplitude of glycemic excursion (MAGE) • Tolerability • Continuous Glucose Satisfaction Scale

  6. Abbott NavigatorTM • Measures interstitial glucose levels • Requires calibration using fingerstick blood glucose at 10, 12, 24 and 72 hours after insertion • After a 10-hr warm-up, provides glucose readings every 60 seconds for up to 120 hours • Operating range 20 - 500 mg/dL • Displays a trend arrow indicating glucose rate of change • Alarms for actual or impending high or low glucose levels

  7. Study Subjects – Phase II

  8. Results – Sensor Use 200 CSII MDI 160 120 80 Navigator Use (hours/week) 40 0 # subjects with zero use: 0 0 0 0 1 4 2 0 0 1 0 5 5 3 BL 1-4 5-8 9-13 14-17 18-21 22-26

  9. Results – Glycemic Control CSII 9.0 MDI 8.0 HbA1c (%) 7.0 6.0 Baseline Wk 7 Wk 13 Wk 26

  10. Results – Glycemic Control CSII 220 MDI 200 180 Mean Blood Glucose (mg/dL) 160 140 BL 1-4 5-8 9-13 14-17 18-21 22-26

  11. Results – Glycemic Targets CSII 80% MDI 70% 60% Percentage sensor Glucose Values In Target Range (71-180 mg/dL) 50% 40% 30% BL 1-4 5-8 9-13 14-17 18-21 22-26

  12. Results – Hypoglycemia (MDI) CSII MDI 8% 6% Percentage sensor Glucose Values Below Target Range (< 70 mg/dL) 4% 2% 0% BL 1-4 5-8 9-13 14-17 18-21 22-26

  13. Results – Glycemic Variability CSII MDI 160 140 Mean Amplitude of Glycemic Excursion (MAGE, mg/dL) 120 100 80 BL 1-4 5-8 9-13 14-17 18-21 22-26

  14. Capillary Blood Glucose Testing Need a graph like others showing meter use (tests/day) over course of study

  15. CGM Satisfaction Scores are out of a 5 point Likert scale

  16. Factors Predictive of Continued Use can be like table from paper, but need p-values

  17. Conclusions • Navigator was well-tolerated in pediatric subjects using either CSII or glargine-based basal-bolus MDI over 26 weeks • Decrease in sensor use over time • Early improvements in A1c, percentage of glucose levels in range, and glycemic variability • No baseline factors were predictive of successful extended use • Short-term use, early drop in HbA1c, and higher levels of CGM satisfaction predict successful extended use

  18. Barbara Davis Center • H. Peter Chase • Rosanna Fiallo-Scharer • Laurel Messer • Barbara Tallant • University of Iowa • Eva Tsalikian • Michael Tansey • Linda Larson • Julie Coffey • Joanne Cabbage • Nemours Children’s Clinic • Tim Wysocki • Nelly Mauras • Larry Fox • Keisha Bird • Kim Englert • Stanford University • Bruce Buckingham • Darrell Wilson • Jennifer Block • Paula Clinton • Yale University • William Tamborlane • Stuart Weinzimer • Brett Ives • Amy Steffen • Jaeb Center for Health Research • Roy Beck • Katrina Ruedy • Craig Kollman • Dongyuan Xing • Cynthia Stockdale

  19. The following slides are just audience questions

  20. Audience Question 1:(before presentation) • On a scale of 1 (lowest) to 5 (highest), how would you rate the tolerability of continuous glucose sensors in the management of children with diabetes ? • 1. Completely intolerable • 2. Somewhat intolerable • 3. Neither tolerable nor intolerable • 4. Somewhat tolerable • 5. Very tolerable

  21. Audience Question 2:(before presentation) • On a scale of 1 (lowest) to 5 (highest), how would you rate the usefulness of continuous glucose sensors in the management of children with diabetes ? • 1. Completely useless • 2. Somewhat useless • 3. Neither useful nor useless • 4. Somewhat useful • 5. Very useful

  22. Audience Question 3:(before presentation) • On a scale of 1 (lowest) to 5 (highest), how likely would you be to recommend the use of continuous glucose sensors in the management of children with diabetes ? • 1. Very unlikely • 2. Somewhat unlikely • 3. Neither unlikely nor likely • 4. Somewhat likely • 5. Very likely

  23. Audience Question 1:(after presentation) • On a scale of 1 (lowest) to 5 (highest), how would you rate the tolerability of continuous glucose sensors in the management of children with diabetes ? • 1. Completely intolerable • 2. Somewhat intolerable • 3. Neither tolerable nor intolerable • 4. Somewhat tolerable • 5. Very tolerable

  24. Audience Question 2:(after presentation) • On a scale of 1 (lowest) to 5 (highest), how would you rate the usefulness of continuous glucose sensors in the management of children with diabetes ? • 1. Completely useless • 2. Somewhat useless • 3. Neither useful nor useless • 4. Somewhat useful • 5. Very useful

  25. Audience Question 3:(after presentation) • On a scale of 1 (lowest) to 5 (highest), how likely would you be to recommend the use of continuous glucose sensors in the management of children with diabetes ? • 1. Very unlikely • 2. Somewhat unlikely • 3. Neither unlikely nor likely • 4. Somewhat likely • 5. Very likely

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