Insulin Pumps and Glucose Sensors in Diabetes Management
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1 Diabetes Update Congress Whistler, British Columbia Friday March 21, 2014ǀ 8:15 8:45 am Insulin Pumps and Glucose Sensors in Diabetes Management Bruce A Perkins MD MPH Division of Endocrinology Associate Professor and Clinician-Scientist
2 Dualities of Interest Disclosure (Commercial Entities) Speaker Fees: Glaxo Smith Kline, Inc; Medtronic Minimed, Inc; Johnson and Johnson-Animas; Roche; Eli Lilly Canada; Novo Nordisk; Sanofi Research Support Medtronic Minimed, Inc; Boehringer Ingelheim; Novo Nordisk Advisory Panel Neurometrix, Inc.
3 Key Objectives: In these next 25 minutes, you will PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY Be able to cite the key studies that support use of CGM in clinical practice. Understand some of the methodological limitations of CGM and Pump RCTs. Describe the 2013 publications focused on strategies for hypoglycemia prevention SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY
4 The Diabetes Control and Complications Trial 1 (DCCT) Provides Best Evidence to Date for Intensive Management but long-term adherence was difficult once the study ended More Need self-management for novel strategies How do we reconcile the problem of long-term adherence to glycemic control? 1 DCCT/EDIC Research Group. N Engl J Med. 2000;342:381-9.
5 Audience Question In a T1D patient on MDI and suboptimal A1c, you anticipate the least A1c reduction from which of the following interventions: 1. Insulin pump therapy 2. Stand-alone CGM 3. Sensor-augmented pump therapy
6 Studies of Pump Therapy Alone in T1D: Pump Therapy vs. MDI Trials, Outcome A1c PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Comment on T2D Misso ML et al, Cochrane Database Syst Rev Jan
7
8 Enzyme-based technology PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Gluconic Acid Glucose + O 2 H 2 O 2 + Gluconic Acid H 2 O V H 2 O + 2 e - Boyne et al. Diabetes 2003
9 PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Langendan M et al. CGM systems for T1DM (Systematic Review). Cochrane Database 2012.
10 Key Point #1 Evidence Strongly Supports the use of CGM to Augment Pump Therapy PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Langendan M et al. CGM systems for T1DM (Systematic Review). Cochrane Database 2012.
11 A1C Primary Endpoint: A1C Reduction for SAP and MDI for All Patients (N = 485) 8.5% 8.0% 8.3% 8.0% 8.0% 8.1% 8.1% P< % 7.0% 7.5% 7.5% 7.5% 7.3% Months = SAP = MDI n = 244 n = 241 Maximal A1C reduction was correlated with sensor use in post-hoc analysis A1c reduction durable to 18 months in a non-randomized continuation phase Comparisons between SAP group and MDI group are significant for each time period (P<0.001). Bergenstal, et al. N Engl J Med Bergenstal, et al. Diabetes Care 2011
12 AUC (mg / dl x min) AUC (mg / dl x min) AUC for Hyper- and Hypoglycemia: All Patients Hyperglycemia AUC (>180 mg/dl or >10mM) Hypoglycemia AUC (< 70 mg/dl or <4mM) 40 p< p = Extent & duration of hyperglycemia in SAP was a third lower compared to MDI but not so for hypoglycemia Baseline 1 Year 0 Baseline 1 Year = SAP = MDI n = 247 n = 248 Comparisons between SAP group and MDI group are significant for each time period (P<0.001). Bergenstal, et al. N Engl J Med. 2010;363:
13 Eurythmics Study N= 83 in 8 European centres, A1c > 8.2% PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Hermanides Diabetic Medicine 2011
14 Key Point #1a Evidence to Support SENSOR AUGMENTED PUMP is substantial. Hermanides Diabetic Medicine 2011
15 Studies of the Effect of CGM Alone (in patients with A1c 7-10%) Major Benefit in Adults JDRF Continuous Glucose Monitoring Study Group. N Engl J Med JDRF Continuous Glucose Monitoring Study Group. Diabetes Care 2009 PUMPS and CGM n=98 PUMPS IN CONTEXT CGM TECHNOLOGY 0.53%, P<0.001 SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY 6 month study, N=322. Insignificant effect of CGM on younger subgroups (n=224) A separate report of 129 subjects with A1c <7.0% showed substantial benefit in a composite outcome including hypoglycemic events
16 Studies of the Effect of CGM Alone in the context of SAP - SWITCH STUDY PUMPS and CGM * PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES Adult (n=81) Pediatric (n=72) Overall (n=153) HYPO PREVENTION STRATEGIES SUMMARY *p< N=153 in 4 European Centres, pump patients with inclusion criteria otherwise similar to STAR 3 Battelino Diabetologia. 2012
17 Key Point #2: The Evidence Supports a Moderate Independent Effect of CGM on A1c Reduction Treat to target* Body of evidence summary for A1c reduction: RealTrend* CGM Alone: % over 6 months SAP: 0.6 to 0.7 % over 6-12 months compared to MDI -0.43% (-0.32 to -0.55; P<0.001) *Pump Studies, akin to Switch Battelino Diabetologia. 2012
18 Messages from the 150-page Cochrane Review (Continued) PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY Key Point #3: Evidence for the intermittent use of real time CGM reflects the results of the Switch Study in which the A1c benefit is lost after continuous use is stopped.* Key Point #4: Evidence for retrospective (blinded) CGM is very limited but does not support A1c benefit. SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES *Exception: GuardControl Study demonstrated good short-term A1c effect from bi-weekly sensor use. SUMMARY Deiss D GuardControl Study. Diabetes Care. 2006
19 Audience Question Use of an automated basal shut-off algorithm with sensoraugmented pump therapy accomplishes which of the following: 1. Reduces A1c more than SAP alone 2. Prevents hypo only in high-risk patients 3. Prevents day- and night-time hypoglycemia 4. Increases DKA risk
20 The ASPIRE In-Home trial (Automation to Simulate Pancreatic Insulin Response) Average Patient: 43yo with 27years of T1DM, A1c 7.2%, no recent severe hypo or hospitalization, and wore a sensor 80% of the time in a run-in period. Design: 3-month (2w run-in) randomized, controlled, multi-center, open-labelled trial N= 247. Primary Endpoint (Efficacy): AUC 10p-8a HYPO INTERVENTION SAP with Low Glucose Suspend LGS set at < 3.9 mmol/l CONTROL Standard SAP No LGS Bergenstal RM et al for the ASPIRE In-Home Study Group. N Engl J Med 2013;369:
21 Efficacy PUMPS and CGM Safety PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Number of Discrete Events decreased by 30%: Nocturnal 1.5 vs. 2.2 events per patient week Combined 3.3 vs. 4.7 events per patient week Severe hypoglycemia: 0 vs. 4 total events in the control. Extent & duration of hyperglycemia in LGS/TS was a third (38%) lower compared to Control Bergenstal RM et al for the ASPIRE In-Home Study Group. N Engl J Med 2013;369:
22 Sensor Glucose Values Before, During and After the 2-Hour Low risk of severe rebound Nocturnal hyperglycemia Suspends with LGS 9.4 mmol/l 3.9 mmol/l 5.1 mmol/l There were no DKA events Bergenstal RM, Klonoff DC, Garg SK, et al for the ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypogylycemia. N Engl J Med 2013;369: Bergenstal RM et al for the ASPIRE In-Home Study Group. N Engl J Med 2013;369:
23 PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Average Patient: 18yo with 11years of T1DM, A1c 7.5%, on pump and with NEAR-TOTAL LOSS OF HYPOGLYCEMIA AWARENESS. Design: 6-month randomized, controlled, multi-center, openlabelled trial N= 95. Primary Endpoint (Efficacy): moderate (assistance) to severe (seizure/coma)hypoglycemia episodes Ly et al. JAMA Sept 26, 2013
24 Incidence Rates of Moderate-Severe Hypoglycemia *(Adjusted to baseline rates) 70% lower Average Percentage of hours spent in SG <3.9 Nocturnal 4.4 vs % Daytime 4.1 vs. 6.9 % Bergenstal RM, Klonoff DC, Garg SK, et al for the ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypogylycemia. N Engl J Med 2013;369: Ly et al. JAMA Sept 26, 2013
25 We can implement Technological Awareness now. PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Courtesy of Richard Bergenstal.
26 Antecedent Hypoglycemia Challenges Both Physiological and Technological Awareness. Garg et al. The Order Effect in the ASPIRE In-Clinic Study. DT&T 2014
27 Approaches to overcome the challenge of A1c Reduction: Trials of PUMP THERAPY ALONE Minor A1c reduction (0.25% over 3-12 months) PUMPS and CGM PUMPS IN CONTEXT CGM TECHNOLOGY SAP & CGM-SPECIFIC STUDIES HYPO PREVENTION STRATEGIES SUMMARY Trials of CONTINUOUS GLUCOSE MONITORING ALONE Minor-moderate A1c reduction ( % over 6 months) Trials of SENSOR-AUGMENTED PUMP THERAPY vs. MDI More marked A1c reduction ( % over 6-12 months) Approaches to overcome the challenge of Hypoglycemia Reduction: THRESHOLD-BASED PUMP SUSPENSION is associated with substantially lower risk of minor (30-40%) and major (70%) hypoglycemia incidence, intensity and duration. Reality Check: Benefits need to be balanced by the increased technological demands on the patient.
28 Toll-free
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