USOO6633772B2 (12) United States Patent (10) Patent No.: US 6,633,772 B2 Ford et al. (45) Date of Patent: Oct. 14, 2003 (54) FORMULATION AND MANIPULATION OF WO WO 96/00109 1/1996 DATABASES OF ANALYTE AND WO WO 97/02811 1/1997 ASSOCATED WALUES WO WO 99/58190 11/1999 WO WO OO/07013 A 2/2000 (75) Inventors: Russell Ford, Portola Valley, CA (US); WO WO OO/471.09 A 8/2000 Matthew J. Lesho, San Mateo, CA (US); Russell O. Potts, San Francisco, OTHER PUBLICATIONS CA (US); Michael J. Tierney, San Jose, CA (US); Charles W. Wei, Bolinder et al., “Self-Monitoring of Blood Glucose in Type Fremont, CA (US) I Diabetic Patients: Comparison with Continuous Microdi alysis Measurements of Glucose in Subcutaneous Adipose (73) Assignee: Cygnus, Inc., Redwood City, CA (US) Tissue During Ordinary Life Conditions,” Diabetes Care (*) Notice: Subject to any disclaimer, the term of this 20(1):64–70 (1997). patent is extended or adjusted under 35 Ohkubo et al., “Intensive Insulin Therapy Prevents the U.S.C. 154(b) by 0 days. Progression of Diabetic Microvascular Complications in Japanese patients with Non-Insulin-Dependent Diabetes (21) Appl. No.: 09/927,583 Mellitus: a Randomized Prospective 6-year Study,” Diabe (22) Filed: Aug. 10, 2001 tes Research & Clinical Practice 28:103–117 (1995). (65) Prior Publication Data (List continued on next page.) US 2002/0045808 A1 Apr. 18, 2002 O O Primary Examiner Robert L. Nasser Related U.S. Application Data (74) Attorney, Agent, or Firm-Barbara McClung; Gary (60) Provisional application No. 60/226.205, filed on Aug. 18, Fabi 2000. O (51) Int. Cl. .................................................. A61B 5/00 (57) ABSTRACT (52) U.S. Cl. ....................... 600/345; (90.7 600/365; The present invention relates to methods of formulating 600/300; 707/104.1 analyte data databases, the databases themselves, and meth (58) Field of Search ......................... 600/300, 345-365; ods of manipulating the same. In one aspect the present 707/104.1 invention includes the formulation of analyte data points, derived data, and data attributes databases comprising data (56) References Cited points collected using an analyte monitoring device capable U.S. PATENT DOCUMENTS of frequent monitoring of analyte concentrations or amounts. Such data points may comprise acquired data (e.g., 4,703,756 A 11/1987 Gough et al. values corresponding to analyte concentrations or amounts 4,803,625 A 2/1989 Fu et al. as measured by said analyte monitoring device). These data 5,247.666 A * 9/1993 Buckwold ................... 707/100 points are then associated with one or more relevant data 5,251,126 A * 10/1993 Kahn et al. ................. 600/309 attributes. The resulting databases may be manipulated to (List continued on next page.) determine relationships among the components of the data base. FOREIGN PATENT DOCUMENTS EP O 483595 A 5/1992 30 Claims, 9 Drawing Sheets US se?sor A sensor mog record log entry record date $8quence Q es elapsed ionio into senso: A elapsed sensor 8 elapsed Sweat records status type iype ninter| USED is tire totage current | current bit current in Reading toro, SHDN.s copio2 (0). E.E 0-47 7-32.47-32. C. a ON, SEAT SWEAT 3 OK 3 SHUTXWN 4/25.00 11:54: i. 32 20.2 42.5 0:00:00 --> --- -- - - - - --- OK 3 NEWBA 4,260 2:56:6 32 2.2 22.8 0-000 m My MM - - - -- 2 OK 3. StART 428. 3:28:4 32 20.2 2. 0:0000 --ma an a-- --- an -- -a- 3 ck 2 8C 4|asig 13:29:41 34 20.4 28. -au - Y --- 384 S8 3612 S8 --- 4 K 2 88C 4288) 13:30:41 34 2.4 x86 --- - --- 2477 11.8 2332 18 a s OK NX8. 428O 3:30:46s 34 20.4 28 O02:S -2.2 0.02 --- --- na s K MN 4:280 13:31:46 3. 20.4 28.4 iO3:08 -32 0.82 m am un K 1 MION 4,260 13:32:41 34 20.4 28.7 0:04:01 -3.2 {02 --- wa-a- W 3. OK 2 88 4iaSix 3:34: 42 21.2 29.8 - M - -- ma Y - g OK M8iC} 4t26.00 13:3S:41 42 2.2 30.4 --- M. M. --- --- YM - ic ck 2 83 4,2800 3:38:4 42 2.2 30.7 --- ama- Y 428 358 -- OK 2 MBC 4,280 3:48.4 42 212 3. am M ma 3585 479 ---- 2 C< 2 MBC 4,263 13:42:41 42 2.2 3.2 --M amm m 3.256 598 m 43 CK N: 42808 3:44.9 42 22 30.7 s:8:29 8.9 18 an na an --- --- 34 CK MLQ8 &#2600 13.45:36 42 21.2 3.9 0:16:56 9.7 0.32 -- - M. --- nu s OK 2 BO 4,260 3:49:4 42 21.2 3.7 --- --- nam 245 238 23 239 nam 16 OK 2 MBIO 4,260 13:53:41 42 212 31.8 -am -- --- 217 478 26 479 --- 17 OK McN 4,260 3:53:58 42 2.2 3.2 25:8 -1.7 0.32 M --- --- -- 18 cK i MON 42600 3.36:41 42 21.2 36 :28.8 --- --- --- a-u- - 19 OK 2 MBO 4,260 3:58: a2 22 32.2 -- 239 9 328 19 m 20 OK 2 M3ts 26X) 8:004 42 22 32.2 m 238 239 375 238 2 OK 2 MBO 4iaex 14:024 42 25.2 33 aam 216 359 246 359 22 OK 2 Mao 4:600 4:03.2 42 21.2 3.9 --- 212 399 242 39S -- 23 OK 2 MBO 4.i.2600 4:03:26 42 21.2 31.3 Y 22 4x4 241 404 28 OK 4 SWAT aiz80 14:03:41 35 20.5 3i, 0.33:0 ---> --- - - - - - - -- 0.41485 2s OK McN 4:2600 4:03:37 33 23 3.2 :35:7 9 C32 ----- r----- a--- --- --- 26 OK 1 MEON 4:28 4:06:38 33 20.3 31.5 37:58 7 .32 a v na- --- --- --- 2: Ok 4 SWA 4,260 46.43 35 20.5 3.9 0.38:1 M --- a -- --- --- m-m- 0.2S774 28 CK 2 BO 4,2SX 4:06:5 33 20.3 32.3 -- 879 9 728 9. m-- 29 OK 2 MBO 4,250 4:08:55 33 20.3 3. --- 884 4 SS1 14 mW 30 OK 2 MalC. 4.28/30 4:07:81 33 2O3 32. - S63 19 465 g -- 3. OK 2 3O aaSXC 4:57: 33 20.3 32.2 wom 464 29 383 29 --- 32 OK 2 ABIC 4,2800 4:#2 33 20.3 32.2 ma Y- ma 45 39 338 39 - US 6,633,772 B2 Page 2 U.S. PATENT DOCUMENTS 6.284,126 B1 9/2001 Kurnik et al. 6,298.254 B2 10/2001 Tamada 5,279.543 1/1994 Glikfeld et al. 6,299,578 B1 10/2001 Kurnik et al. 5,362,307 11/1994 Guy et al. 6,309,351 B1 10/2001 Kurnik et al. 5,458,140 10/1995 Eppstein et al. 6,326,160 B1 12/2001 Dunn et al. 5,462,051 10/1995 Oka et al. 5,507,288 4/1996 Böcker et al. OTHER PUBLICATIONS 5,569,186 10/1996 Lord et al. 5,730,714 3/1998 Guy et al. UK Prospective Diabetes Study (UKPDS) Group., “Effect of 5,735,273 4/1998 Kurnik et al. Intensive Blood-Glucose Control With Metformin on Com 5,747,806 5/1998 Khalil et al. plications in Overweight Patients with Type 2 Diabetes 5,771,890 6/1998 Tamada (UKPDS 34).” Lancet 352:837–853 (1998). 5,822,715 10/1998 Worthington et al. 5,827,183 10/1998 Kurnik et al. Bolinder et al., Diabetes Care 20:64–70 (1997). 5,914,701 6/1999 Gersheneld et al. Newman et al., “Catalytic Materials, Membranes, and Fab 5,954,685 9/1999 Tierney rication Technologies Suitable for the Construction of 5,960,403 9/1999 Brown Amperometric Biosensors,” Analytical Chemistry 5,989,408 11/1999 Bacrts et al. 67:4594-4599 (1995). 6,023,629 2/2000 Tamada Ohkubo et al., Diabetes Research & Clinical Practice 6,024.699 2/2000 Surwit et al. 28:103-117 (1995). 6,139,718 10/2000 Kurnik et al. Tamada et al., “Noninvasive Glucose Monitoring," JAMA 6,141573 10/2000 Kurnik et al. 6,144,869 11/2000 Berner et al. 282:1839–1844 (1999). 6,180,416 1/2001 Kurnik et al. UK Prospective Diabetes Study (UKPDS) Group. Lancet 6,201.979 3/2001 Kurnik et al. 352:837-853 (1998). 6,233,471 5/2001 Berner et al. Updike et al., “The Enzyme Electrode,” Nature 6,272,364 8/2001 Kurnik 214:986–988 (1967). 6,277,071 8/2001 Hennessey et al. - - - - - - - - - 600/300 6,278.999 8/2001 Knapp ............... - - - - - - - - - - - - 707/9 * cited by examiner U.S. Patent US 6,633,772 B2 ri re U.S. Patent 10N OBST! U.S. Patent Oct. 14, 2003 Sheet 4 of 9 US 6,633,772 B2 Status Date Time (START), CAL, OK Or ERR CORRUPT MEAL O OK 4/26/OO 13:28 UNCA 1 OK 4/26/OO 16:43 CAL 2 OK 4/26/00 17:03 ERR63 3 OK 4/26/OO 5 OK 4/26/OO 6 OK 4/26/OO 18:23 GLOK 193 7 OK 4/26/OO 18:43 G.