Track 2. Clinical Research & Care s339

of hypoglycemia, not related to the device, occurred which was treated with intravenous glucose and a decrease in the patient’s insulin dose. Conchrsion: The new 3.0 mL pretilled pen offers patients with diabetes and HCP a simple, convenient and easy to use system, allowing for single unit dosage adjustments. The new pen’s safety profile was also judged clinically acceptable by study investigators.

P1351 Changing Clinical Profile and Prognosis of Fibrocalculous Pancreatic Diabetes from North India NAVEEN MITTAL ’ , Ghanshyam Agarwal ’ , Ravi Mehrotra ’ , G. Choudhuri2, Sadiq S. Sikora3, Eesh Bhatia’. ’ Dept ofEndocrinology; 2 Dept of Gastroenterology; 3 Dept of Surgical Gastroentemlogy, Sanjay Gandhi Postgraduate Institute, Lucknow, Uttar Pradesh, India

Fibrocalculous Pancreatic Diabetes (FCPD) is a secondary form of di- abetes, limited to developing countries. The clinical presentation and prognosis of FCPD may have changed from its original description. Aim: To describe the clinical features, prevalence of microvascular complica- tions and prognosis on follow-up of a cohort of FCPD subjects. Materials and methods: We studied 73 consecutive North Indian patients of FCPD over a period of 10 years. Results: Only 15% patients belonged to lower socioecomomic group. The mean age at onset of pain was 19f9 (range 5-48) years and of diabetes 27flO (range 1 l-60) years. At presentation hyperglycemia was of variable severity: 9 (12.5%) were asymptomatic (diagnosed on oral glucose tolerance test) while 25 (34%) presented with severe insulin-requiring diabetes. Only 1.4% had ketones at presentation while 11% had ketosis on follow up. At the onset of diabetes only 25 (34%) patients required insulin. Of the 48 patients who were controlled with diet/oral hypoglycemic agents (OHA) originally, 22 (46%) required insulin after 2 years. In comparison to patients who required insulin at onset, patients on diet/OHAdiffered significantly in their HbAlc (9.6f3.9 vs 7.4f2.7%, p=O.OOS) and fasting C-peptide (0.16fO.l vs 0.32f0.22 pmol/ml, p=O.O3). The mean body mass index (BMI) was 17.7f3.2 kg/m* and 42 (58%) had BMI r18 kg/m’. Subjects with low BMI did not differ from those with normal BMI in their clinical presentation or C-peptide levels. The prevalence of microvascular complications was:retinopathy [background in 9 (12%). proliferative in 4 (5.4%)], nephropathy in 14 (19%). and neuropathy in 18 (25%). Nephropathy and/or retinopathy was more common in patients with duration of diabetes >5 years (7/52 vs 10/21, pt0.01). Out of 40 patients seen in last 2 years, 4 (10%) had died: 2 of carcinoma of pancreas, 1 of septicemia and I of chronic renal failure. Conclusions: The spectrum of FCPD differs considerably from previous descriptions. Microvascular complications are frequent. Carcinoma of pancreas is a common cause of mortality.

P1352 The Clinical Performance and Utility of Glycosaf HbAt,, a New and Novel Rapid Point-Of-Care Test, in Hospitals, Diabetic Clinics and General Practice ANTHONY STEVENSON. Research and Development, Provalis Diagnostics, Deeside, Flintshire, United Kingdom

Glycosal’” has been clinically validated in the hands of the diabetic practice nurse and hospital clinic technician, to deliver laboratory level precision (5 5% CV) measurement of HbAt,at the point-of-care in under 5 minutes. Glycosal’” allows testing to be performed at the bedside, in the diabetic clinic or doctors office during a normal consultation and by relatively non-technical personnel, e.g. GP, nurse or clinic technician, using as little as 10~1 of capillary blood. Glycosal” has a linear range of at least 4 - 15% HbAt, and the test is calibrated to accurately report HbAI, results to the Diabetes Control and Complications Trial (DCCT) study group reference system.

Glycosal” was clinically evaluated at five distinct medical centres across the UK, ranging from hospital pathology departments to GP surgeries and local health centre diabetic clinics. The personnel performing the testing was chosen to include both tech- nically experienced pathology department scientists and also relatively unskilled nursing staff. During the course of the study, each site performed parallel HbAi, determinations on at least 24 routine diabetic patient blood samples, both by their established pathology laboratorymethod and by the Glycosal WA,, test. All Glycosal testing was performed by either the laboratory scientist, practice nurse, or clinic technician. The correlation of Glycosal to the routine HbAt, methods at the 5 study sites ranged from correlation coefficients (r) of 0.93 - 0.98. Where the routine method was, like Glycosal HbAt,, also calibrated directly to the DCCT reference system the agreement between results ranged from slopes of between 0.95 0.98. The outcome of the study demonstrates the clinical performance of Glycosal HbA,, in the hands of the laboratory scientist or the unskilled nurse, to be highly satisfactory in providing an immediate assessment of the diabetic patients HbAt, status at the point-of-care. The Glycosal WA,, test enables the immediate consultation and discus- sion of the result between the patient and diabetic physician at the time of presentation, which has recently been shown to help improve the overall glycaemic status of diabetics compared to conventional management.

P1353 The Relationship between Impaired Glucose Transporter Function and Hyperglycaemia in Non-Insulin Dependent Diabetes Mellitus MELANIE M. PORTER-TURNER. Joanne C. Skidmore, Yichuan Wen, Carol A. Rea, Mohammed A. Khokher, Baldev M. singh. School of Health Sciences, Universiry of Wolverhampton, Wolverhampton, West Midlands, United Kingdom

The study has been designed to test the hypotheses that glycation of GLUT-l transporter inhibits non-insulin mediated glucose uptake function. Erythrocyte glucose transport was studied in vitro to evalu- ate GLUT-1 transporter function comparing diabetic patients (n=19) to non-diabetic controls (n =18) (age 48fll v 48&9 y, not significantly different (ns), BMI 31.3f7.9 v 27.7f3.4 kg/m2(ns), HbAlc% 7.742.1 v 4.7f0.3 (p<O.OOl)).In washed red cell suspensions at 20% haematoctit using 36°C over 20 minutes we determined RBC glucose influx, efflux and net metabolism using cross incubation (1OmM to 0, 0 to 1OmM and 1OmM to lOmM, respectively, supematant versus erythrocyte intra- cellular glucose concentration). Glucose influx was significantly lower in diabetic patients (93f75 v 162f51 ~mol/min/(ten to the power of twelve)erythrocytes, p<O.Ol) whilst glucose efflux rates were similar (78f37 v 62f24 ~mol/min/(ten to the power of twelve)erythrocytes(ns)). There were no significant differences in 3-0-methylglucose uptake or glucose phosphorylation rates as measured using 2-deoxy glucose. There was a negative correlation between glucose influx and HbAlc (r = -0.36, p~O.05). We conclude that diabetes has an apparent differential effect upon erythrocyte glucose transport in respect to influx and efflux and this probably represents altered GLUT-l function.

P1354 Multicentre Study of the Use of a New Insulin Injection Pen by Patients with Type 2 Diabetes JULIE LLEWELYN, Smiljana Ristec, Peter Bates, Jane Martin, Eli Lilly and Company, Windlesham, Surrey, United Kingdom

Background and Aims: A new reusable 3.0 mL insulin injection pen (HumaPe@) has been developed. In order to assess its utility in the daily management of patients with type 2 diabetes, a multicentm clinical study has been carried out. Materials and Methods: The study involved

s340 Poster Session 2

121 patients (62% male; 38% female) in France, Hungary, Ireland and the UK. Mean age of the patients was 58.2 years (range: 37-75 years). They had taken insulin for a mean of 38 months (range: 2-408 months). Prior to the study, all patients administered at least two insulin injections per day with NovoPen” 3 devices. At study entry, patients changed to the HumaPen for all insulin injections for a period of 5 to 7 weeks, while their insulin regimens remained unaltered. At the end of the study, a questionnaire, developed previously in conjunction with patients and healthcare professionals (HCP), was completed. Results: The proportion of patients who rated the HumaPen as easy/very easy for individual questions were: reading the dose numbers, 97% of patients; correcting the insulin dose, 96%; learning to use the insulin pen, 96%; checking the insulin flow, 87%: and changing the cartridge, 83%. Overall ease of use of the HumaPen was rated easy/very easy by 74% of the patients. In comparison with NovoPen 3, HumaPen was considered easier/much easier for correcting a mis-dialled dose (89%). reading the dose numbers (77%) and changing the cartridge (54%). The HumaPen was considered as easy/easier to use than the NovoPen 3 by 74% of patients. The proportion of patients who said that they would continue to use the HumaPen after the study was 60%, while 74% said that they would recommend the HumaPen to other patients with diabetes. The 13 HCP involved in the study also completed a questionnaire about the HumaPen and a11 said that they would recommend it to their patients with type 2 diabetes, due to ease of dialling back without losing insulin (100%) and ease of use (77%). There were 258 pens issued to patients during the study and 26 were reported with problems, 19 of which were due to injection force issues. The study therefore identified some areas for improvement and the HumaPen has since been modified. Conclusion: This study demonstrated that the HumaPen was well accepted by patients with type 2 diabetes.

P1355 The Application of Staged Diabetes Management to Screening for Renal Disease RACHEL L. ROBINSON’, Gregg D. Simonson’, Evan Benjamin*, Linda Clark3. ’ Research and Development, Inkrnational Diabetes Center. Minneapolis, MN: 2 Dept. of Medicine, Tufrs University SchooL of Medicine, Springfield, MA; 3 Diabetes Team, U.S.EH.S. Indian Health Service, San Carlos, AZ, United States of America

Ten to twenty-one percent of people with diabetes develop kidney dis- ease, making diabetes the most common cause of End Stage Renal Disease(ESRD)in the United States. Persistent or increasing microalbu- minuria indicates early diabetic nephropathy and represents a twentyfold greater risk for the development of ESRD in patients with type 2 diabetes. In 1995 a program was implemented to directly address nephropatby surveillance and detection. Using the Staged Diabetes Management Prac- tice Guidelines for Microalbuminuria Screening, Diagnosis and Treatment and for the Diagnosis and Treatment of Hypertension the program resulted in significant improvement in the screening for and treatment of these conditions. Four sites are presented here.

Sample Size Baseline Post-SDM p-value TImeframe

Site I Microdbuminuria screening 900 19% 68% (N=950) <O.OOl 24 months

Patients w/Hylpertension 71% 55% <O.Ool

Use of ACE in patients 31% 79% <O.OOl

w/hypertension

Site 2 6 months

Microalbuminuria screening 60 21% 64% <O.cOl

Site 3 15 months

Microalbuminuria screening 144 45% 91% <O.cOl

Site 4 18 months

Microdbuminutia screening IS 17.4% 78.1% (N=56) <O.cnl

Site 1 was a remote Indian Health Service clinic with limited resources and difficulty in patient access. Site 2 was a small community hospi-

tal and clinic with limited availability of subspecialists. Site 3 was a controlled study undertaken at a large urban teaching hospital serving a predominantly Hispanic and African American population. While there was significant increase in screening at the SDM site, no improvement in the screening rate occurred at the control site. Site 4 was a multi-site study held in a Managed Care Organization in which primary care clinicians and subspecialists worked together. The use of SDM resulted in a significant increase in the proportion of patients screened for microalbuminuria and hypertension. This improved screening for early onset renal disease offers primary care providers the opportunity to delay the onset of ESRD.

P1356 Diabetes Outcomes Improvement Following a Systematic Process for Implementation of Clinical Guidelines RENEA A. BRADLEY ’ , Gregg D. Simonson ’ , Marcia Madden ‘, Theodore Loftness*, Delores Berrien-Jones 3, Roberta Eis 3, Todd Weaver ’ , Roger Mazze ’ . ’ In~emarional Diabetes Center, Minneapolis, MN; 2Allina HealrhSystem, Minneapolis, MN: ‘Henry Ford Health System, Detroit, MI, United States of America

The purpose of this study was to determine if a systematic process to implement diabetes guidelines in a managed care organization (MCO) and a large integrated healthcare system (IHS) resulted in improved dia- hetes-related outcomes. Using the Staged Diabetes Management (SDM) program, a protocol-based approach for clinical decision-making, each organization took part in a multi-step process for implementation. Step 1. SDM Program Introduction and Assessment: A formal presen- tation was made to health professionals and administrators to acquaint them with the program and determine their level of readiness. A diabetes team and champion were appointed to facilitate SDM implementation and establish objectives for the program. A needs assessment and baseline chart audit were conducted to establish current diabetes care, identify barriers and the need for resources, materials and training. Step 2. Customization of Guidelines and Training of Providers: Trained facilitators guided the providers through a consensus-building process to customize the SDM guidelines and algorithms (DecisionPaths). Cus- tomization reflected organizational resources and practices. Case studies were used to promote the utilization of the customized guidelines. Step 3. Implementation: Using data collected from a baseline chart au- dit, the diabetes team set priorities, identified goals and developed an implementation plan for SDM. Step 4. Follow-up: Follow-up measures were collected from the MC0 and the MS. Results were evaluated and communicated to providers. The MC0 demonstrated significant improvement (p<O.OOOl)in diabetes- related outcomes at baseline versus 18 months post-SDM implementation.

Cti@ia HbAlc SMBG Diabetes Mlcroalbumin AIIllUd AllnUal

3-4 p&r Education Testing Foot Exam Eye Exam

Baseline (N=86) 26% 36% 21% 15% 22% 36%

Post SDM (N=73) 50% 56% 37% 57% 59% 57%

Similar results were demonstrated in a 12 month study conducted at the IHS. Mean HbAlc was reduced from 10.6% to 8.3% for 55 pa- tients receiving care in accordance with SDM. In a concurrent control group(n=70), mean HbAlc increased slightly from 10.5% to 10.8%. Moreover, physicians utilizing the SDM guidelines were able to reduce the number of patients with HhAlc 29.5% from 87% to 21%, while patients with HbAlc >9.5% in the control group increased from 86% to 90%.