Special Diabetes Program for Indians Competitive Grant Program SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects Core Elements Update July 28, 2009

SDPI Competitive Grant Program Recruitment Core Elements The intent of these Core Elements is to: 1.Define the goal for number of participants enrolled in the DP or HH program. 2.Give examples of how to recruit eligible individuals. 3.Define reporting requirements related to Recruitment. Recent revisions to DP and HH Demonstration Projects reflects new dataset reporting effective 8/1/09. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects

SDPI Competitive Grant Program DP Changes Recruitment goal = 48 new participants/year Informed Consent for participation in intensive activities is only necessary if required by local IRB or other approving authority. Documentation of Recruitment activities for internal use and for reporting to IHS. HH Changes Recruitment goal = 50 new participants/year Informed Consent for participation in intensive activities is only necessary if required by local IRB or other approving authority. Documentation of Recruitment activities for internal use and for reporting to IHS. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects Recruitment Core Elements

SDPI Competitive Grant Program Screening and Eligibility Core Elements The intent of these Core Elements is to establish guidelines for grant program staff to screen interested individuals using current clinical guidelines based on national standards. - IHS, ADA, NIH, etc. Recent revisions to the DP and HH Demonstration Projects reflects new clinical guidelines and new dataset reporting effective 8/1/09. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects

SDPI Competitive Grant Program DP Changes Diagnosis of Metabolic Syndrome without diabetes now eligible Any 1 of 3 glycemic measures OK for dx of PreDM: 1)Fasting Blood Glucose (FBG), 2)Oral Glucose Tolerance Test (OGTT) or 3)A1c. (Do not use a Casual glucose in the clinic setting.) Community screening unchanged. Delay B.A. until 1 month prior to the individual’s first class if class not starting, then retest at that time with either a FBG, an OGTT, or an A1c. A glycemic measurement is required every 6 months. HH Changes Diagnosis of Metabolic Syndrome without diabetes now eligible Any 1 of 3 glycemic measures OK for dx of Type 2 DM : 1)Fasting Blood Glucose (FBG), 2)Oral Glucose Tolerance Test (OGTT) or 3)A1c. (Do not use a Casual glucose in the clinic setting.) Community screening unchanged. A diagnosis of diabetes requires 2 glycemic measurements within the diabetes range, taken on different days (preferably within 2 weeks). SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects Screening and Eligibility Core Elements

SDPI Competitive Grant Program DP Changes Diagnosis of Pre-Diabetes Fasting blood glucose mg/dl (Impaired Fasting Glucose, IFG) 2-hour glucose mg/dl (Impaired Glucose Tolerance, IGT) A1c > 6.0 and < 6.5 (note: this remains an area of controversy for the diabetes community. Our best evidence suggests this cut-off at this time.) Casual sugar 140 – 199 mg/dl (note: this is not considered diagnostic of pre-diabetes – another glycemic test is required for the diagnosis of pre- diabetes.) HH Changes Diagnosis of Diabetes Fasting blood glucose > 126 mg/dl 2-hour glucose >200 mg/dl plus symptoms of diabetes A1c > 6.5 (note: this remains an area of controversy for the diabetes community. Our best evidence suggests this cut-off at this time.) Casual sugar > 200 plus symptoms of diabetes A diagnosis of diabetes requires 2 glycemic measurements within the diabetes range, taken on different days (preferably within 2 weeks). SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects Screening and Eligibility Core Elements, cont.

SDPI Competitive Grant Program Intensive Activities Core Elements These Core Elements describe: 1.DPP Curriculum for DP Program 2.Case Management for HH Program The intent of these Core Elements is to describe required activities and reporting related to specific interventions. Recent revisions to DP and HH Demonstration Projects reflects new clinical guidelines and new dataset reporting effective 8/1/09. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects

SDPI Competitive Grant Program DP Changes Team Meetings - monthly or quarterly as needed ECG within 1 year before Baseline recommended but not required Lab Tests: 1. Lipid profile within three months prior to the start of DPP curriculum class 2. Glycemic measurement within one month prior to the start of the first DPP curriculum class 3. Urine albumin within one month prior to the start of the first DPP curriculum class 4. Glycemic measurement every 6 mos Document for internal use and for reporting to IHS: team meetings and members of team who attended and After Core activities HH Changes Team meetings - monthly or quarterly as needed ECG within one month before the first Case Management Visit recommended but not required Lab tests 1. Lipid profile within three months before the first Case Management Visit 2. Glycemic measurement within one month before the first Case Management Visit 3. Urine albumin within one month before the first Case Management visit Document team meetings and members of team who attended for internal use and for reporting to IHS. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects Intensive Activities Core Elements

SDPI Competitive Grant Program Retention Core Elements The intent of these Core Elements is to: 1.Assist programs in tracking active participants. 2.Develop a Retention Recovery Plan to assist in re-engaging inactive participants. 3.Provide ideas and strategies for reducing barriers to participation in program activities. Recent revisions to DP and HH Demonstration Projects reflects new dataset reporting effective 8/1/09. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects

SDPI Competitive Grant Program DP Changes Retention Goal: 100% of your participants. Document specific types of retention plan activities or strategies used during the year (types of retention activities, describe use/participation, impact/evaluation) for internal use and for reporting to IHS. HH Changes Retention Goal: 100% of your participants. Document specific types of retention plan activities or strategies used during the year (types of retention activities, describe use/participation, impact/evaluation) for internal use and for reporting to IHS. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects Retention Core Elements