SDPI Demonstration Projects Grantee Meeting June 2008

1. SDPI Demonstration Projects Grantee Meeting June 2008 IHS Division of Diabetes Update Kelly Acton, MD, MPH, FACP Director IHS Division of Diabetes Treatment & Prevention

2. IHS Division of Diabetes Update • Congress extends SDPI funding through FY09 • SDPI funding to remain unchanged • Year 5 SDPI Demonstration Projects • DHHS approval for deviation • SDPI Carryover Plan • New DDTP website coming • 508 compliance issues • Highlights from the ADA Scientific Sessions

3. Congress extends SDPI funding through FY09 SDPI Competitive Grant Program • Original legislation (H.R. 5738 ) extended SDPI through FY08 • H.R. 2764 extends SDPI funding through FY09 at $150M per year • Original legislative language still applies (“…to make grants for the purpose of prevention and treatment of diabetes…”)

4. SDPI funding to remain unchanged SDPI Competitive Grant Program • February 2008: TLDC considers changes to the SDPI program • March 2008: Tribal consultation occurs • March 2008: TLDC decides to recommend that SDPI funding remain unchanged • May 2008: IHS Director accepts TLDC recommendation and decides that SDPI funds will be distributed in the same manner as was done in FY04-08

5. Year 5 SDPI Demonstration Projects SDPI Competitive Grant Program • Year 5: HH & DP Demo Programs continue to recruit & deliver the interventions • Funding will remain equal to previous years • June 2009: end of intensive data collection; transition to less intensive recruitment & data reporting

6. DHHS approval for deviation SDPI Competitive Grant Program • Feb 2008:DGO/DGP inform DDTP and TLDC that a competitive process is required for compliance with DHHS grants policy • Feb 2008: TLDC strongly requests waiver from competition for one year process • March 2008: DGO/DGP request waiver from DHHS competitive grant policy • April 2008: waiver (“deviation”) granted for FY09 only; will not be allowed if SDPI extended beyond FY09

7. Ideas for Using SDPI Carryover Funds • Carryover Policy • All carryover funds must be used to support the original goals and objectives of the project (prevention and treatment of diabetes) • If the carryover is used during a project extension, the terms and conditions of the award continue to apply to the grantee during the extended period

8. SDPI Carryover Plan SDPI Competitive Grant Program Ideas for Using SDPI Carryover Funds: Background • SDPI funds have been targeted at building local / Tribal program infrastructure for prevention and improved treatment of diabetes • May be a limit to the amount of funds the local infrastructure can efficiently and productively absorb over a given period of time. • Tribes have been good stewards of these resources and have not simply “spent down” funds. • Result is a carryover of congressionally appropriated funds. • One solution to this issue may be to redirect some of these funds to enhance national and regional infrastructure to complement the ongoing efforts directed at local infrastructure and support Tribal efforts to combat diabetes.

9. SDPI Carryover Plan SDPI Competitive Grant Program Ideas for Using SDPI Carryover Funds: Carryover Policy • All carryover funds must be used to support the original goals and objectives of the project (prevention and treatment of diabetes) • If the carryover is used during a project extension, the terms and conditions of the award continue to apply to the grantee during the extended period

10. SDPI Carryover Plan SDPI Competitive Grant Program • Feb 2008: DGO/DGP express serious concern to TLDC about SDPI carryover at ~$117M • Feb 2008: TLDC establishes a TLDC Carryover sub-committee • March-April 2008: DGO/DGP and DDTP develop options for carryover use • May 2008: TLDC recommends that carryover funds stay with grantee through September 2008 & training be provided on how to reconcile Payment Mgmt System • May-June 2008: DGO/DGP provide weekly training to grantees via Web-ex

11. SDPI Carryover Plan SDPI Competitive Grant Program • July 7, 2008: SF 269 completed & sent to DGO • July 7, 2008: SF 272 updated in PMS • July 7-31, 2008: Grantees develop carryover applications • August 1, 2008: Carryover applications due to DGO • August 1-31, 2008: Applications reviewed by DDTP • Sept 3-15, 2008: DGO review, approve & issue modified NOAs • Sept 15, 2008: Leftover carryover funds are considered by TLDC and IHS Director

12. Ideas for Spending SDPI Carryover: Demonstration Projects SDPI Competitive Grant Program • “Incentives” (exercise motivators?) • Medications • Supplies • Training / staff retreats & team re-invigoration • RPMS transfer of data function

13. IHS Division of Diabetes Update • Congress extends SDPI funding through FY09 • SDPI funding to remain unchanged • Year 5 SDPI Demonstration Projects • DHHS approval for deviation • SDPI Carryover Plan • New DDTP website coming • 508 compliance issues • Highlights from the ADA Scientific Sessions

14. Highlights from the ADA Scientific Sessions SDPI Competitive Grant Program • Glycemic control & CVD: ACCORD, ADVANCE and the VA Diabetes Trial • Hypoglycemia and MI • Sleep apnea and diabetes • Depression and diabetes • A new model for treating type 2 diabetes • Estimated average glucose (eAG)

15. Pathophysiology of Diabetes SDPI Competitive Grant Program • Impaired insulin secretion • Decreased glucose uptake (insulin resistance) • Increased basal hepatic glucose production • Increased lipolysis (h FFA & lipotoxicity) • Incretin effects (GLP-1 & GIP) • Islet alpha cell glucagon secretion (hyperglucagonemia) • Kidney resorbs glucose in hyperglycemia • brain neurotransmitter dysfunction (impaired appetite regulation & altered hypothalamicfunction)

16. New Treatment Paradigm for Type 2 Diabetes? SDPI Competitive Grant Program • “Old” way: lifestyle + metformin + maybe sulfonylurea • “New” paradigm: preserve maximum beta cell function with lifestyle + metformin + TZD + exenatide (Byetta) • start aggressive treatment early on to get maximum benefit

17. Highlights from the ADA Scientific Sessions SDPI Competitive Grant Program Estimated average glucose (eAG) • New international standard of A1C test has been developed that is more precise in measuring glycated hemoglobins. But new test results in a "normal range'' for A1C that is 1.5- 2% lower than the range currently used. • A1C matches estimated average glucose (eAG) in both type 1 and type 2 patients. • ADA and others will begin promoting the use of the term eAG and asking labs to report that value.

18. Highlights from the ADA Scientific Sessions SDPI Competitive Grant Program Estimated average glucose (eAG): A1C of 6% = eAG of 126 mg/dl A1C of 6.5% = eAG of 140 A1C of 7% = eAG of 154 A1C of 7.5% = eAG of 169 A1C of 8% = eAG of 183 A1C of 8.5% = eAG of 197 A1C of 9% = eAG of 212 A1C of 9.5% = eAG of 226 A1C of 10% = eAG of 240 ** ADAonline calculator at www.diabetes.org/AG Translating the hemoglobin A1c assay into estimated average glucose values. Nathan D, Kuenen J, Borg R, Zheng H, Schoenfeld D, and Heine RJ, for the A1c-Derived Average Glucose (ADAG) Study Group.  Diabetes Care 2008

19. The Special Diabetes Program for Indians: On the Path to a Diabetes-free Future IHS Division of Diabetes Treatment & Prevention 5300 Homestead Rd NE Albuquerque, NM 87110 505-248-4182 diabetes@mail.ihs.gov www.diabetes.ihs.gov