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Use of the GlucoWatch Biographer in Children With Type 1 Diabetes

H. Peter Chase, MD^*, Mary D. Roberts, MD^*, Clare Wightman, BA^*, Georgeanna Klingensmith, MD^*, Satish K. Garg, MD^*, Michelle Van Wyhe, MS, Shashi Desai, BS, Wesley Harper, BS, Margarita Lopatin, MS, Miroslaw Bartkowiak, PhD, Janet Tamada, PhD and Richard C. Eastman, MD

^* Department of Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, Denver, Colorado
Corona del Mar, California
Cygnus, Inc, Redwood City, California

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	ABSTRACT

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION CONCLUSIONS REFERENCES

 
Objective. To determine whether use of the GlucoWatch biographer improves glucose control in children and adolescents with type 1 diabetes.

Methods. Forty children in poor glucose control (glycohemoglobin [HbA1c] >8%) were randomized to diabetes management with or without glucose monitoring using the biographer. Conventional glucose monitoring was performed 4 times daily in both groups. Those randomized to the biographer group were asked to wear the device 4 times per week for 3 months (intervention phase) and to perform blood glucose monitoring if the biographer alerted them that glucose was 70 mg/dL (3.9 mmol/L) or 300 mg/dL (16.7 mmol/L). After 3 months, all patients received biographers and were followed for 6 months (observation phase). HbA1c values were determined at baseline and after 1, 3, 6, and 9 months.

Results. The median HbA1c was 8.6% and 8.9% (control versus biographer) at baseline and was significantly lower in the biographer group after 3 months (8.4% vs 9%). More hypoglycemia was detected when subjects were wearing the biographer, especially at night. No severe hypoglycemia occurred. During the observation phase, HbA1c values at 6 months were 8.5% and 8.3% and at 9 months were 8.6% and 8.4% in the control and biographer groups, respectively. Two children dropped out of the study, 1 because of skin irritation from using the device.

Conclusions. The GlucoWatch biographer was well tolerated by children and adolescents and significantly improved glucose control compared with standard therapy. The use of the biographer with an alarm to detect nocturnal hypoglycemia has the potential to increase the safety of diabetes management in children.

Key Words: type 1 diabetes • GlucoWatch biographer • hypoglycemia • hemoglobin A1c

Abbreviations: DCCT, Diabetes Control and Complications Trial • HbA1c, glycohemoglobin

	INTRODUCTION

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The Diabetes Control and Complications Trial (DCCT) showed that intensive treatment of type 1 diabetes significantly reduced the risk of the development and progression of the eye, kidney, and nerve complications of diabetes.¹ Glucose monitoring 4 or more times daily was an important component of the intensive treatment regimen. Unfortunately, many patients, particularly adolescents, do not monitor blood glucose >1 or 2 times per day.²

The major risk of intensive diabetes management in the DCCT was a 2- to 3-fold increase in the incidence of severe hypoglycemia.³ Fifty-five percent of the severe hypoglycemia events occurred during the sleeping hours, when glucose levels are monitored infrequently. Similarly, 56% of severe hypoglycemic events in children have been documented to occur during the sleeping hours.⁴ A method of monitoring glucose levels frequently and automatically, with an alarm for hypoglycemia, would be of great value in managing diabetes intensively.

The GlucoWatch biographer is a device that was developed to provide frequent and automatic glucose readings noninvasively, to facilitate both the short- and long-term management of diabetes. The device extracts sodium and other cations across the skin by the process of iontophoresis. Glucose is measured in the extracted fluid using glucose oxidase to oxidize glucose to peroxide, and a platinum-containing electrode then oxidizes peroxide and generates an electrical current. The device provides up to 4 glucose readings per hour for up to 12 hours of monitoring. A 3-hour equilibration period is necessary, during which glucose flux across the skin is established. A blood glucose value must be entered in the device for calibration at the end of this warm-up period, to correct for differences in flux at different extraction sites. The device has been shown to be safe, and the glucose levels have correlated well with finger stick blood glucose levels in adults.^5–7 A study has also shown similar accuracy and safety in children and adolescents.⁸ The purpose of this study was to determine whether use of the biographer in children with type 1 diabetes in the home setting would lead to improved glucose control.

	METHODS

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Forty children were randomized to 1 of 2 groups and treated for 3 months (intervention phase). The intervention group used the biographer as an adjunctive measure to conventional glucose monitoring, and the control group used only conventional glucose monitoring. All subjects were in poor glucose control, with at least 2 glycohemoglobin (HbA1c) values 8% in the 9 months before the study. No subject had a history of severe hypoglycemia in the previous 6 months, although many had experienced seizures as a result of hypoglycemia at earlier times. Patients with serious illnesses other than diabetes or with known diabetic complications were excluded. In the biographer group, 6 children received insulin pump treatment, 2 received 3 or more insulin injections daily, and 12 were taking 2 injections daily. In the control group, 7 subjects were using insulin pumps, 5 were taking 3 or more insulin injections daily, and 8 subjects were taking 2 shots daily. Both groups monitored blood glucose at least 4 times daily. Before participation in the study, all children and their parents signed assent and consent forms, respectively. The study protocol, consent, and assent were approved by the Western Institutional Review Board.

The 20 children who were randomized to the biographer group initially participated in a 15-hour accuracy study in the clinic setting (similar to the adult studies previously reported).⁵ While at the center for the accuracy study, they and their parents were given training on the use of the biographer. For the clinical trial, the children were asked to wear the biographer for 2 daytime and 2 nighttime applications per week. AutoSensors were provided to those who wished to wear the biographer more frequently. The AutoSensor is a nonreusable pad that attaches to the GlucoWatch biographer. It is a multilayered device that consists of 2 gel discs that contain glucose oxidase, the electrode systems for applying current across the skin to extract glucose-containing interstitial fluid, and the platinum-containing electrodes that are used to generate the electrical signal from peroxide.

All children and parents were also trained to use the Precision Xtra meter (a conventional blood glucose meter; Abbott Laboratories, Inc, Bedford, MA) exclusively during the period of study. The families in the biographer intervention group were required to bring their biographers and their meters to the center for downloading each week for 12 weeks. The families with subjects in the control group either brought their blood glucose meters or faxed their blood glucose values weekly to the center and brought their meters to the center at least once monthly for downloading. One physician (H.P.C.) reviewed the weekly glucose data from both groups and telephoned the families within 24 hours regarding suggested insulin adjustments. Every effort was made to treat the 2 groups in an identical manner, except for use of the biographer data in the intervention group to aid in managing the patients’ diabetes. All families agreed not to make major changes in therapy (dietary changes, new insulins or method of delivering insulin, etc) during the intervention phase of the study.

At the end of the intervention phase, subjects in the control group received biographers and were trained to use the device. All subjects were followed for an additional 6 months, using the biographer as often as they desired.

The HbA1c values of each child were determined at the start of the study and after 1, 3, 6, and 9 months. HbA1c values were determined using the DCA 2000 instrument (Bayer, Inc, Tarrytown, NY) with a nondiabetic range of 4.3% to 6.3%. The laboratory in which the determinations were performed is Clinical Laboratory Improvement Amendments-approved. College of American Pathology standards, which are run 3 times annually, have never been outside the accepted values.⁹ HbA1c results were masked for the care providers and the families during the intervention phase of the trial. A medical monitor who was not involved with the study reviewed the HbA1c values and alerted the treating physician when the HbA1c was 10% or higher.

Each participant completed the Fear of Hypoglycemia and the DCCT Quality of Life questionnaires initially, after 1 month, and after 3 months of the study.^10,11 Both questionnaires are based on a 5-point Likert scale (1 = disease has no impact; 5 = highly impacted by disease). Each participant’s questionnaire was assigned a total value based on the sum of the individual question responses. The range for the Fear of Hypoglycemia and the Quality of Life questionnaires were 27 to 135 and 44 to 220, respectively, with lower totals meaning less fear or more satisfied, respectively.

Biographer glucose readings were displayed to the subjects and their families during both the intervention and the observation phases of the trial. The biographer’s alarms were set to warn subjects/families of biographer values 70 mg/dL (3.9 mmol/L) and 300 mg/dL (16.7 mmol/L). Families were asked to do a finger stick and measure blood glucose when the biographer alarms for high glucose and low glucose sounded.

The biographer extracts fluid across the skin by reverse iontophoresis using a very small electric current from an AAA battery.¹² Glucose is analyzed by a glucose oxidase/platinum electrode sensor. The method of extracting fluid and analyzing glucose concentrations used by the biographer results in a lag behind the corresponding blood glucose values of 15 minutes. Measurements are skipped for various reasons, including large temperature changes, sweating that exceeds a predetermined threshold for skin conductivity, and mechanical shock.

Hypoglycemia was defined as a blood glucose concentration or biographer glucose reading 70 mg/dL (3.9 mmol/L). Only 1 event was counted for each hour of low glucose readings. Thus, a biographer that gave low values from 12 AM to 6 AM would be counted as 6 hypoglycemia events (although there may have been up to 18 low biographer readings). Hyperglycemia was defined as a blood glucose reading 300 mg/dL (16.7 mmol/L).

The Wilcoxon Rank Sum test was used to analyze the difference in glycosylated hemoglobin concentrations between the control and biographer treatment groups.¹³ Analyses were done using JMP SAS version 4.0.4 (SAS Institute, Cary, NC). During the observation phase, the groups were analyzed by their original treatment group assignment. Differences in hypoglycemia events between the treatment groups were analyzed by ².^{14 2} analyses were performed using Mathematica version 4.1 statistical software (Wolfram Research, Inc, Champaign, IL). Data are presented as the mean ± standard deviation unless otherwise noted.

	RESULTS

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Biographer and control group subjects were 11.9 ± 3.1 years of age (range: 7–16) and 11.9 ± 3.3 years of age (range: 7–17) and had diabetes for 7.1 ± 3.9 years (range: 2.3–14.4) and 5.5 ± 2.5 years (range: 2.0–9.4). There were 12 boys and 8 girls in the biographer group and 9 boys and 11 girls in the control group. One subject was black, and 1 subject was Asian. The others were white.

Patients on average used the biographers 3.5 times each week during the intervention phase. The distribution of time of day of initiating biographer usage peaked at 0600 and 1600 hours (Fig 1).

On the basis of the electronic records from the biographers, there were 901 successful biographer uses for a total of 9373 hours of biographer glucose monitoring during the intervention phase (Table 1). Usage was greater during the initial weeks of the study than in the final weeks. The percentage of biographer readings 300 mg/dL (16.7 mmol/L) significantly decreased (², P < .0001) with time, whereas the percentage of readings 70 mg/dL increased (², P < .002).

View larger version (22K): [in this window] [in a new window]   Fig 2. Detection of hypoglycemia. The y axis is the rate of hypoglycemia events (per 100 person hours) detected by blood glucose monitoring. Data are shown for the entire 24-hour period (left black columns), during the day (6 AM to 10 PM) (middle white columns), and during the night (10 PM to 6 AM) (right black columns). For the biographer group, the rates are shown while the subjects were wearing the biographer and on the days that the subjects elected not to wear the biographer. *Statistically significant differences between rates in the control group and the biographer group.

View larger version (14K): [in this window] [in a new window]   Fig 3. Median HbA1c. The x axis is the study month. Results for the control group are shown by the solid symbols, and for the group allocated to the biographer use during the intervention phase by the open symbols. All subjects were allowed to use the biographer during the observation phase of the study (3–9 months).

One subject dropped out of the study for psychosocial reasons after 2 months of participation. One of the children using the biographer had more than a mild skin reaction (graded using a modified Draize scale¹⁵). He stopped wearing the biographer after 6 weeks of participation in the treatment phase and dropped out of the study during the observation phase.

There were no significant differences in either the Fear of Hypoglycemia or the Quality of Life scores between the control and biographer groups during the intervention phase of the study. The scores were 59 ± 14.3 versus 56.4 ± 9.6 after 3 months for the Fear of Hypoglycemia scale and 81.3 ± 11.7 versus 79.8 ± 15.5 for the Quality of Life scores, respectively.

Over the course of the intervention phase, there were 901 successful and 954 unsuccessful calibrations of the biographers. Half of the attempted calibrations were aborted because the readings failed the preprogrammed data integrity checks: changing background signal, low signal, or disagreement between the readings from the 2 separate electrode systems in the device. These failures can result from a number of factors, including changing temperature, rapidly changing blood glucose, incorrect preparation of the AutoSensor, incorrect preparation of the intended wear site, and high skin resistance at the wear site. Sixteen percent of the aborted calibrations were attributable to changes in skin temperature. Eight percent of the calibration attempts were aborted because the blood glucose was out of range (<40 mg/dL [2.2 mmol/L] or >279 mg/dL [15.5 mmol/L]). Relatively few calibrations were aborted as a result of sweating. Approximately 30% of attempts to recalibrate the biographer after an aborted calibration were successful. Low signal (reflecting low glucose extraction) was by far the most common reason for failure to calibrate.

The biographer did not report (skipped) 24%, 30%, and 32% of the possible readings during the 3 months of the intervention phase, respectively. Most of the skips were attributable to failure of the readings to meet data integrity checks as a result of differences between the 2 electrode systems or changes in temperature.

	DISCUSSION

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION CONCLUSIONS REFERENCES

 
This is the first report of the use of the GlucoWatch biographer to manage diabetes in children, of prolonged use in the home setting, and of use of the biographer when subjects and their families were able to read the glucose values and respond to the biographer alarms for low and high glucose levels. Patients who used the device were able to achieve significantly lower HbA1c values during the study. Use of the biographer seems to be the main difference leading to the improved glucose control. The treatment assignment was made randomly, and the treatment goals and intensity of treatment were similar in both groups. More frequent insulin dose changes were not made in those using the biographer, suggesting that other changes in aspects of the treatment regimen occurred. In the 3 months, each child wore the biographer on an average of 42 different occasions (3.5 times/week). It has been shown that even wearing the Medtronic-Minimed Continuous Glucose Monitoring System for a single period of wear averaging 69.5 hours resulted in a significant decline in HbA1c.¹⁶ The provision of more data on glucose values enabled patients and providers to change insulin doses, corrective algorithms, treatment of hypoglycemia, glucose management at night, regimens for high-fat meals and high glycemic foods, and the management of exercise. In addition, some patients were referred for counseling to improve adherence with the treatment program.¹⁶ Although not quantified in the present study, all of these alterations were used for 1 or more patients.

The protocol called for patients to perform conventional glucose monitoring in response to biographer readings 70 mg/dL (3.9 mmol/L). On average, 16% of the biographer readings were in this range. Thus, it is not surprising that more hypoglycemia was detected by blood glucose monitoring in the group that used the biographer. The greatest relative increase in the rate of detecting hypoglycemia occurred on the nights that subjects wore the biographer, times when hypoglycemia risk is the highest and glucose monitoring is not routinely performed, demonstrating the utility of the biographer’s hypoglycemia alarm. The rate of detecting hypoglycemia at night was also greater on the nights that those in the biographer treatment group were not actually wearing the device. This could reflect the lower HbA1c levels as a result of more aggressive management of glycemia based on biographer data, or greater awareness of nocturnal hypoglycemia resulting from the experience on biographer wear days. This cannot be determined with certainty because of the study design. However, it is our belief that the latter explanation is most likely and that patients in the biographer group were more aware of hypoglycemia at night and were checking for it more often even when they were not wearing the device. Studies using the continuous glucose monitor (Medtronic-Minimed Inc, Sylmar, CA) have also shown that subjects with type 1 diabetes have a similar frequency of hypoglycemia, particularly at night, as described in the present study.^16–19

There were some concerns with the use of the biographer. The major complaints were difficulty calibrating the device, difficulty in hearing or responding to the hypoglycemia alarm, and the incidence of alarms that occurred at night when glucose was not low (1.5 alarms for each low glucose detected). Failure to prepare the biographer properly for use may lead to calibration failure. The biographer also will not calibrate if the blood glucose is >279 mg/dL (15.5 mmol/L) or < 40 mg/dL (2.2 mmol/L); if there are significant changes in skin temperature, excessive sweating, and mechanical shock; or if the biographer detects through preprogrammed integrity checks that the system is not functioning optimally (eg, if there is poor electrical continuity between the skin and the AutoSensor or between the AutoSensor and the biographer). Sleeping through the alarm may have been at least in part secondary to reduced awareness as a result of hypoglycemia. Careful supervision of children who use the device is likely to be required to achieve optimal performance. Future versions of the device should consider different approaches to make the alarm more effective during the night and reduce the number of false-positive alarms.

Skin irritation from use of the biographer was not a major factor. The only child with >1 irritation from the biographer had previously seen a dermatologist for atopic dermatitis. The children in this study seemed to have less irritation than the adults we previously studied.⁵

	CONCLUSIONS

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The GlucoWatch biographer was shown to be useful in this randomized, controlled study in children. It was well tolerated, glycemic control improved, and the biographer alarms led to greater detection of hypoglycemia than occurs with conventional glucose monitoring.

View larger version (32K): [in this window] [in a new window]   Fig 1. Usability of the biographer. The top panel is the frequency distribution of biographer uses. The x axis is the number of biographer uses each week, and the y axis is the percentage of subject weeks for each of the use frequencies. The bottom panel shows the time of day when biographer uses were initiated. The x axis is time of day (0 = between midnight and 2 AM, 2 between 2 AM and 4 AM, etc), and the y axis is the percentage of all uses that were started at that time of day.

	ACKNOWLEDGMENTS

GlucoWatch is a registered trademark of Cygnus, Inc, Redwood City, California. Precision Xtra is a registered trademark of Abbott Laboratories, Bedford, Massachusetts.

	FOOTNOTES

 
Received for publication Mar 26, 2002; Accepted Aug 20, 2002.

Reprint requests to (R.C.E.) Cygnus, Inc, 400 Penobscot Dr, Redwood City, CA 94063. E-mail: reastman{at}cygn.com

	REFERENCES

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This Article Abstract Full Text (PDF) P3Rs: Submit a response Alert me when this article is cited Alert me when P3Rs are posted Alert me if a correction is posted Citation Map Services E-mail this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via ISI Web of Science (26) Citing Articles via Google Scholar Google Scholar Articles by Chase, H. P. Articles by Eastman, R. C. Search for Related Content PubMed PubMed Citation Articles by Chase, H. P. Articles by Eastman, R. C. Related Collections Endocrinology

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