A Feasibility Study of Remote Monitoring of CAPD Patient’s

Blood Pressure and Blood Glucose Measurements Via the

Internet

G. Pylypchuck, P. Jacobson, C. McAllister

University of Saskatchewan, St Paul’s Hospital, Department of Nephrology, ChroniCare

Abstract A FEASIBILITY STUDY OF REMOTE MONITORING OF CAPD PATIENT’S BLOOD PRESSURE AND

BLOOD GLUCOSE MEASUREMENTS VIA THE INTERNET. G. Pylypchuk, P. Jacobson, C. McAllister University of Saskatchewan, St. Paul’s Hospital, Saskatoon, Saskatchewan. ChroniCare, Regina, Saskatchewan

The purpose of this study was to determine the feasibility of remotely monitoring blood pressure (BP) and glucose measurements in a cohort of diabetic patients receiving continuous ambulatory peritoneal dialysis (CAPD). This can be achieved using BP monitors, glucometers and a ChroniCare appliance (HealthGate) to transmit the data to a secure internet server over a home telephone access. Tight control of BP and blood sugar has been proven to improve both mortality and renal function in diabetic patients with end stage renal disease. Physician access to real time BP and glucose measurements via the internet may allow for better control of these clinical parameters over time. Seventeen diabetic patients currently monitored by St. Paul’s Hospital dialysis unit were selected to trial this equipment. After three initial hospital visits for baseline measurement of BP, glucose, hemoglobin A1c and equipment education, subjects were instructed to continue monitoring their BP and glucose levels at the same intervals conducted at home. Subjects were instructed to download their data via telephone line access on a weekly basis. Patients were provided with satisfaction questionnaires to be completed at the end of the trial. The BP and glucose data could then be monitored in real time via internet access from any location. Subjects began the study with a mean BP of 147/72 +/- 24/18 mmHg, and a mean Hemoglobin A1c level of 7.6 ± 1.2%. Baseline BP, glucose and Hemoglobin A1c levels were compared to values at the end of the study. The mean number of values downloaded per week was 11.9 ± 11.2 with a range between 2 and 48. Of 17 subjects who began the trial, 15 have been successfully transmitting data on a regular basis. One subject refused to use the equipment after completing the initial visits and education and two have been experiencing technical difficulties. It was possible to view the continuous trend of these vital signs in real time. Data was immediately available using internet access and can be viewed in both tabular and graphical formats. Limits may be set for each parameter to notify the physicians when dangerous values are recorded. This data may be used in the future studies to make meaningful changes to the patients’ medication regimens. CAPD patients only come to the hospital for follow-up every 2-3 months and it is hypothesized that this tool will allow more rapid changes in treatment effects and patient compliance. Future studies are planned to determine the long term effectiveness of this tool on BP and glucose control in this patient population.

Introduction Many patients treated with continuous ambulatory peritoneal dialysis (CAPD) live in

locations remote from their active dialysis center. These patients are seen by their nephrologist on average once every three months at the dialysis center. Apart from these visits, routine management of both dialysis and their co morbid conditions depends upon decisions of the patient and their family physician. Many patients live long distances from the dialysis center making more frequent follow up both difficult and expensive.

Two of the most common co morbidities affecting peritoneal dialysis patients are diabetes and hypertension. Many studies have proven that tight control of blood glucose and blood pressure improve both mortality and renal function in diabetic patients with end stage renal disease. Current practice leaves routine monitoring of these critical parameters up to the patient. Records of self assessment are kept by each patient and are evaluated at each follow up visit with the family physician or nephrologist. Subsequent diagnostic decisions are based upon the patients self reporting of blood sugar and blood pressure measurements take at home.

New technology may make monitoring of both blood pressure and blood glucose easier and more effective for this patient population. ChroniCare has developed a telephone based appliance (HealthGate) which incorporates both patient used blood pressure machines and glucometers. Blood pressure and glucose are each measured in their routine fashion with a blood pressure cuff and glucometer. After measurement, the data is transmitted to a secure server via telephone access using the HealthGate appliance. Both the patient and their physician once supplied with the appropriate authentication rights can then access the data over the internet to assist with medical management. The data can be accessed in real time. All data is conveniently displayed on a web site www.chronicare.ca in both graphical at numeric formats. The web site is designed with algorithms to provide mean and standard deviation data of three different time frames, the most recent 2 weeks, 4 weeks, as well as all accumulated data. Acceptable limits are set for each parameter measured. The number of data points that fall outside of the selected range are also identified. Use of this technology has not been validated in CAPD patients living in remote locations from their dialysis center.

The purpose of this study was to determine the feasibility of using this technology in a cohort of diabetic CAPD patients.

Methods Seventeen subjects were recruited from the population of diabetic CAPD patients in

Saskatoon, Saskatchewan. All patients were recruited in the fall of 2004. Two of the patients subsequently dropped out of the study. Patients were provided with a blood pressure monitor and a glucometer together with an telephone compatible hookup (HealthGate appliance) for downloading their measurements. Each patient was scheduled for an initial training visit at the Saskatoon peritoneal dialysis clinic. On the initial visit, baseline demographic data, blood pressure, glucose and hemoglobin A1c measurements were taken. They were also provided with their HealthGate appliance and instructed in its use. Regular telephone technical support was provided to each subject on an as needed basis to assist with equipment difficulty.

Subjects were instructed to download their data on a weekly basis. They were not instructed how often to measure their vital signs, this was to be done as per their normal practice at home. Blood pressure, glucose and heart rate data were monitored on a regular basis by the CAPD clinic staff via the ChroniCare website. There were however no clinical decisions made based on the observed data. After a minimum of four weeks of equipment use, a telephone questionnaire was conducted to assess the quality of the equipment and the ease of use by the subjects.

Results Data was collected and transmitted to the internet using the HealthGate appliance

(Figure 1). The downloaded vital sings can be viewed via the internet in both tabular and graphical formats (Figure 2, Table 2). All subjects included in the data set have been transmitting data for a minimum of four weeks. Subject demographic information is presented in Table 1. All subjects were diabetic patients with end stage renal disease on CAPD.

Over four weeks, the mean blood glucose was 10.4 ± 3.4 mmol/L and the mean blood pressure was 135.8/73.7 ± 21.2/11.7 mmHg. The mean number of downloads per subject over four weeks was 35.5 ± 26.4 times for glucose and 32 ± 37.4 times for blood pressure.

Results from the patient satisfaction questionnaire are presented in table 3. Overall ease of use was found to be between good and excellent. The quality of all three parts of the workstation were also rated between good and excellent. The patients found the data very easy to transmit using their telephone access. The quality of both the glucometer and the blood pressure cuff were scored between good and excellent. The overall satisfaction of the workstation features and performance were rated between good and excellent.

Discussion The results of this study have demonstrated that it is possible to monitor and

track vital signs in CAPD patients remotely. Patients with access to a telephone can easily transmit data to the internet for immediate monitoring. Data can be viewed in real time on the internet. The data can be organized so that trends can be viewed over time. Negative trends and dangerous readings can be easily identified and acted upon if necessary.

In this population there was a large variance in the number of data points transmitted by each patient. It would be ideal for diabetic patients on CAPD to monitor both their blood glucose and blood pressure levels on frequent intervals as prescribed by their physicians. Patients and their physicians could use this data to make meaningful changes in their medication regimens. A future study is planned to determine the effect of using this technology together with physician based suggestions for medical intervention to determine the overall effect on long term control of blood sugar and blood pressure.

As previously stated, glucose and blood pressure control are very important in diabetic patients on CAPD. This technology allows patients who would normally have infrequent direct physician contact to be closely monitored at much more regular intervals. Though not proven by this study, it is likely that the data transmitted to the internet is much more accurate than the current system of patient self reporting. Hand written records of glucose and blood pressure are prone to multiple errors which should be eliminated by this new technology. Introduction of this technology may introduce new technological errors into medical data collection, but we feel that these technological errors will be much less significant than those of hand written records. This however, has not been clinically proven with this technology. Further study is again required to determine this effect.

As noted from the patient satisfaction questionnaire, this system of collecting blood pressure and blood glucose has been very easy to use in this study cohort. Vital sign measurement was not different than the patients were previously used to and the added step of downloading the data via telephone access was easy to use. Patients overall were very pleased with the quality and ease of use of the equipment. The data presented on the ChroniCare web site is very easy to monitor and is presented in a meaningful format to base clinical decisions upon. This technology should add very useful data to the medical management of diabetic CAPD patients. With effective use this device should add significantly to gain better control of both blood pressure and blood glucose in these patients.

Table 1. Baseline demographic data.

Age (years) 60.9 ± 11.0

Blood Pressure (mmHg)

147/72 ± 24/18

Hgb A1c (%) 7.6 ± 1.2

Sex Male (10) Female (5)

Period n Min. Max. Ave. Stdev. Glucose 2 weeks 75 3.17 15.00 7.81 3.47

4 weeks 101 3.17 15.00 7.95 3.51 All 419 2.94 18.11 7.92 3.14

Systolic 2 weeks 147 75 152 121.24 12.77 4 weeks 147 75 152 121.24 12.77 All 266 75 153 120.64 12.71

Diastolic 2 weeks 147 56 104 71.61 5.87 4 weeks 147 56 104 71.61 5.87 All 266 56 121 72.13 6.63

Pulse 2 weeks 147 58 111 95.80 7.45 4 weeks 147 58 111 95.80 7.45 All 266 58 112 96.36 7.81

Period High Reading Low Reading Glucose 2 weeks 0 above 20.00 13 below 4.00

4 weeks 0 above 20.00 14 below 4.00 All 0 above 20.00 39 below 4.00

Systolic 2 weeks 0 above 180 6 below 100 4 weeks 0 above 180 6 below 100 All 0 above 180 12 below 100

Diastolic 2 weeks 1 above 100 0 below 50 4 weeks 1 above 100 0 below 50 All 3 above 100 0 below 50

Table 2. Example of numeric data from www.chronicare.ca

Table 3. Patient Feedback Questionnaire results

•  Device Mean Score –  Easy to use 4.8 ± 0.4 –  Construction 4.5 ± 0.7 –  Easy to read Display 4.5 ± 0.7 –  Reliability 4.2 ± 1.0

•  Function –  Installation 4.4 ± 0.7 –  Sending data 4.4 ± 0.5 –  Reading the Display 4.3 ± 0.7 –  Glucometer use 4.6 ± 0.5 –  BP cuff use 4.7 ± 0.5 –  Confirmation of Successful transmission 4.3 ± 0.6

•  Overall –  Device Features 4.7 ± 0.5 –  Performance 4.2 ± 0.6

Figure 1. The ChroniCare system. Pictured are: glucometer, blood pressure cuff, and Healthgate appliance for data transmission. (telephone optional)

Figure 2. Graphical representation of glucose data over four weeks.

Questions?

Colin McAllister PEng, PMP, MBA Managing Principal – Perspect Managing Consulting

colinm@perspect.ca www.perspect.ca