Evidence Report Evidence Report 2010 Update: Diabetes and Commercial Motor Vehicle Driver Safety Federal Motor Carrier Safety Administration May 27, 2011 MANILA Consulting Group, Inc. 1420 Beverly Road, Suite 220 McLean, VA 22101 FMCSA Evidence Report: 2010 Update Diabetes and Commercial Motor Vehicle Driver Safety 5/27/2011 Evidence Report 2010 Update: Diabetes and Commercial Motor Vehicle Driver Safety Prepared for: Federal Motor Carrier Safety Administration U.S. Department of Transportation Prepared by: MANILA Consulting Group, Inc. 1420 Beverly Road, Suite 220 McLean, VA 22101 Authors of the 2010 update: Michelle Bieber-Tregear, PhD Damilola Funmilayo, MPH Arit Amana, MPH Dana Connor, BA Stephen Tregear, DPhil Authors of the original report: Stephen Tregear, DPhil MANILA Consulting Group Marie Tiller, PhD ECRI Institute Financial declarations: None of the authors has any affiliations or financial involvement that conflict with the material presented in this report. Policy statement This report was prepared by MANILA Consulting Group, Inc. under Contract No. GS-10F-0177N; Order No. DTMC75-10-F-00013, entitled ―Medical Programs Research and Analysis Panels Project, with the Department of Transportation’s Federal Motor Carrier Safety Administration. 2 FMCSA Evidence Report: 2010 Update Diabetes and Commercial Motor Vehicle Driver Safety 5/27/2011 Table of Contents Executive Summary ...................................................................................................................... 7 Preface .......................................................................................................................................... 12 Organization of Report ........................................................................................................................... 12 Scope ...................................................................................................................................................... 12 Section 1: Background ................................................................................................................ 14 1.1. Diabetes Mellitus ....................................................................................................................... 14 1.2. Epidemiology Data for Diabetes in the United States ............................................................... 15 1.2.1. Prevalence and Incidence of Diabetes Mellitus .................................................................... 15 1.2.2. Mortality ............................................................................................................................... 15 1.2.3. Risk Factors for Diabetes ...................................................................................................... 16 1.3. Economic Burden of Diabetes ................................................................................................... 18 1.4. Treatment of Diabetes Mellitus ................................................................................................. 18 1.5. Side Effects of the Treatment of Diabetes ................................................................................. 26 1.6. Diabetes and Driver Safety ........................................................................................................ 30 1.6.1. The Occurrence of Hypoglycemia While Driving ................................................................ 31 1.6.3. Hypoglycemic Unawareness ................................................................................................. 32 1.7. Complications of Diabetes ........................................................................................................ 34 Section 2: Federal Regulatory and Medical Advisory Criteria for CMV Operators ..... 37 2.1. Current Federal Regulatory Criteria for CMV Operators ......................................................... 37 2.2. Current State Regulatory Criteria for CMV Drivers ................................................................. 40 Section 3: Methods ................................................................................................................ 42 3.1. Key Questions ........................................................................................................................... 42 3.2. Identification of Evidence Bases ............................................................................................... 42 3.2.1. Searches ................................................................................................................................ 44 3.2.2. Retrieval Criteria ................................................................................................................... 44 3.2.3. Inclusion and Exclusion Criteria ........................................................................................... 45 3.3. Evaluation of Quality of Evidence ............................................................................................ 45 3.4. Statistical Methods .................................................................................................................... 46 Section 4: Synthesis of Results ............................................................................................. 48 4.1. Key Question 1: Are individuals with diabetes mellitus at increased risk for a motor vehicle crash when compared with comparable individuals who do not have diabetes? ................................... 48 4.1.1. Identification of Evidence Base ............................................................................................ 48 4.1.2. Evidence Base ....................................................................................................................... 49 4.1.3. Quality of Evidence Base ...................................................................................................... 53 4.1.4. Generalizability of Evidence to Target Population ............................................................... 53 4.1.5. Findings for Key Question 1 ................................................................................................. 57 4.1.6. Section Summary .................................................................................................................. 72 4.2. Key Question 2: Is hypoglycemia an important risk factor for a motor vehicle crash among drivers with diabetes mellitus? ............................................................................................................... 74 4.2.1. Identification of Evidence Base ............................................................................................ 74 4.2.2. Evidence Base ....................................................................................................................... 76 4.2.3. Quality of Evidence Base ...................................................................................................... 80 4.2.4. Generalizability of Evidence to Target Population ............................................................... 81 4.2.5. Findings for Key Question 2 ................................................................................................. 86 4.2.6. Section Summary .................................................................................................................. 98 4.3. Key Question 3: What risk factors are associated with an increased incidence of severe hypoglycemia, and what is the incidence of severe hypoglycemia with different treatments and treatment modalities? ........................................................................................................................... 100 3 FMCSA Evidence Report: 2010 Update Diabetes and Commercial Motor Vehicle Driver Safety 5/27/2011 4.3.1. Risk Factors for Hypoglycemia .......................................................................................... 100 4.3.2. Incidence of Severe Hypoglycemia with Treatment Associated Factors ............................ 106 4.3.3. Injectable, Non-Insulin Drugs for Type 2 Diabetes ............................................................ 113 4.3.4. Findings ............................................................................................................................... 117 4.4. Key Question 4: How Effective is Hypoglycemia Awareness Training in Preventing the Consequences of Hypoglycemia? ........................................................................................................ 119 4.4.1. Identification Evidence Base .............................................................................................. 121 4.4.2. Study Design Details ........................................................................................................... 123 4.4.3. Quality of Evidence Base .................................................................................................... 123 4.4.4. Generalizability of Evidence to Target Population ............................................................. 124 4.4.5. Findings for Key Question 4 ............................................................................................... 125 4.4.6. Section Summary ................................................................................................................ 128 Appendix A: Literature Search Approach ............................................................................. 130 Appendix B: Retrieval and Inclusion Review ........................................................................