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Biomedical subjects

H Peter Chase

Publications and source records attributed to H Peter Chase.

35 records · Page 2Linked to original sources

Lack of accuracy of continuous glucose sensors in healthy, nondiabetic children: results of the Diabetes Research in Children Network (DirecNet) accuracy study.

OBJECTIVE: The workup of hypoglycemia requires frequent glucose sampling. We designed these studies to determine if the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer (GW2B) are sufficiently accurate to use in nondiabetic children. Study design Fifteen healthy children (aged 9-17 years, 11 boys) wore a GW2B and a CGMS during a 24-hour period, and reference serum glucose was measured hourly during the day and half-hourly overnight. RESULTS: Compared with the reference glucose, the median absolute difference in concentrations measured by the GW2B (487 pairs) was 13 mg/dL, and the difference measured by the CGMS was 17 mg/dL (668 pairs), with 30% and 42% of values using the GW2B and CGMS, respectively, deviating >20 mg/dL from the reference value. The GW2B reported values <60 mg/dL in 73% of subjects, the CGMS in 60% of subjects. In none of these episodes was serum glucose truly low. Spurious high glucose concentrations also were observed with the sensors. The mean reference glucose was lowest at 5 am (89 mg/dL) and highest at 11:30 pm (106 mg/dL) during the 24-hour period. CONCLUSIONS: Neither the CGMS nor the GW2B is accurate enough to establish population standards of the glycemic profile of healthy children and cannot be recommended in the workup of hypoglycemia in nondiabetic youth.

Adolescent↗

Glycemic parameters with multiple daily injections using insulin glargine versus insulin pump.

This study compared external insulin pump treatment using insulin lispro or insulin aspart with multiple daily injections (MDI; four or more injections per day) using insulin glargine and insulin lispro or insulin aspart. An electronic database was used to retrieve various parameters of glycemic control for 515 adult patients with type 1 diabetes. An insulin pump was used by 216 patients, and 299 patients were taking insulin glargine for at least 6 months. The mean age (approximately 33 years), duration of diabetes (approximately 16 years), and duration of treatment (approximately 12 months) were similar for both the pump and insulin glargine groups. The mean (+/-SEM) A1C values were significantly reduced in both groups from the baseline to the end of the study (7.7 +/- 0.1% to 7.5 +/- 0.1% for the pump group and 8.0 +/- 0.1% to 7.7 +/- 0.1% for the insulin glargine group, P< 0.001) with similar weight gain (P> 0.05) in both groups. The insulin glargine group significantly reduced basal insulin intake at follow-up. The premeal boluses were similar throughout the study for both groups. The subjects reporting severe hypoglycemic episodes were similar in the two groups; however, there were 12 cases of diabetic ketoacidosis reported in the pump group and none in the insulin glargine group. Patients with type 1 diabetes can achieve similar glycemic control using insulin glargine with premeal insulin lispro or by using an external infusion pump with insulin lispro or insulin aspart. However, costs and episodes of diabetic ketoacidosis are significantly higher for insulin pump users.

Adult↗

Redefining the clinical remission period in children with type 1 diabetes.

PURPOSE: To redefine the clinical remission period for different aged children receiving the current standard of diabetes care. METHODS: An electronic patient records system was used to identify 552 children newly diagnosed with type 1 diabetes (T1D) from 1997 to 2001 who had an initial hemoglobin A1c (HbA1c) value at the time of diagnosis and at least one other value measured in the ensuing year. The insulin dosage previously used to define the remission period [<0.5 units per kg body weight per day (U/kg/d)] was evaluated for the different aged children. RESULTS: The mean insulin dosages for all age groups were >0.5 U/kg/d by 9 months after diagnosis. The mean HbA1c values were above 8% by 6 months after diagnosis for the 6-9 and the 10-12 yr age groups and by 9 months after diagnosis for the >or=13 yr age group. The percentage of children <or=5 yr of age who continued to receive <0.5 U/kg/d of insulin was higher than for the other three age groups. However, this group did not achieve a mean HbA1c value <8% at any time. CONCLUSION: Older children have a longer remission period than younger children. The clinical definition of the remission period should be redefined to include both the insulin dose and the HbA1c level. Any attempt to extend the remission period in children is more apt to be successful in dealing with older children and with the introduction of the intervention as soon after diagnosis as is feasible.

Adolescent↗

Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy.

OBJECTIVE: To identify possible causes of suboptimal glycemic control (ascertained by hemoglobin A1c [HbA1c] level) in youths using insulin pump therapy. METHODS: Forty-eight youths who were receiving insulin pump therapy for > or =6 months, and who were using insulin pumps and blood glucose meters with data that could be downloaded at our facility, are included in this cross-sectional study. Possible causes of suboptimal glycemic control were evaluated by using 4 information sources: 1) insulin pump data downloads; 2) glucose meter data downloads; 3) patient/family questionnaire about insulin bolusing habits, eating habits, exercise, and blood glucose testing habits; and 4) a physician questionnaire. Physicians completed the questionnaire during the patient interview after reviewing the downloaded information and discussing these results with the patient/family. RESULTS: The mean (+/- standard deviation) age of participants was 15.3 (+/-3.0) years (range: 7-20 years), and the mean (+/- standard deviation) duration of type 1 diabetes and continuous subcutaneous insulin infusion was 8.2 (+/-4.0) and 1.9 (+/-1.0) years, respectively. Patients who missed <1 bolus per week had a mean (95% confidence interval) HbA1c level of 8.0% (7.7, 8.3), whereas those who missed > or =1 mealtime boluses per week had a mean HbA1c level (95% confidence interval) of 8.8% (8.6, 9.1). No significant relationships were found between HbA1c levels in males and females, the amount of exercise per week, or bolusing before insulin pump disconnection for exercise. Although not significant, a trend was found for those who missed <1 bolus per week to perform more blood glucose tests per day and for those who bolused before a meal rather than after to have lower HbA1c levels. Significant correlations were found between HbA1c levels and the number of missed mealtime boluses per week (r =.414) and mean blood glucose levels (r =.70). CONCLUSION: Missed mealtime insulin boluses seem to be the major cause of suboptimal glycemic control in youths with diabetes receiving continuous subcutaneous insulin infusion therapy.

Adolescent↗

Elevated C-reactive protein levels in the development of type 1 diabetes.

Elevated C-reactive protein (CRP) levels have previously been described before the onset of type 2 diabetes and gestational diabetes. We hypothesized that inflammation, as reflected by elevated CRP levels, can help predict development of islet autoimmunity or type 1 diabetes. Children at risk for type 1 diabetes and followed in the Diabetes Autoimmunity Study of the Young (DAISY) had blood samples drawn and frozen serum saved at various intervals after birth. CRP was measured using a high-sensitivity sandwich enzyme immunoassay. Islet autoantibodies (IAs) were measured using biochemical immunoassays. Elevations in CRP concentrations were significantly more frequent (P < 0.01) in children who later developed type 1 diabetes (8 of 16 children) than in children negative for IAs at their last testing (3 of 26). Children with one or more positive IA were more likely to have elevated CRP concentrations (15 of 36) than IA-negative children (3 of 26; P < 0.01). The finding of elevated CRP levels in infants and young children before the onset of type 1 diabetes adds to the evidence that the disease is an immunoinflammatory disorder. The elevated CRP levels may provide an additional marker for risk of progression to type 1 diabetes.

Autoantibodies↗

Cost-effectiveness of use of the GlucoWatch Biographer in children and adolescents with type 1 diabetes: a preliminary analysis based on a randomized controlled trial.

OBJECTIVE: To conduct a preliminary analysis of the cost-effectiveness of the use of the GlucoWatch Biographer in the management of type 1 diabetes in children and adolescents. METHODS: The computer model used to analyze the cost-effectiveness of intensive diabetes treatment in the Diabetes Control and Complications Trial (DCCT) was modified to simulate cohorts of patients who participated in a small clinical trial at one center comparing standard and Biographer-assisted standard care. The model is a Monte Carlo simulation model that simulates the lives of individual patients. Cohorts of 10,000 patients are simulated to accumulate statistics on average treatment costs and complications. Complication and treatment costs were updated to 2002 dollars. Future costs and benefits are discounted using a rate of 3%. The perspective of the analysis is from a single payer of health care costs. RESULTS: The model predicts that use of the Biographer, if sustained for the life of the cohort, would delay the development of the first serious diabetes complication by 4.1 yr. Treating 18 subjects would prevent one case of blindness and 1.4 cases of renal failure. The intervention costs $91,059/years-of-life (YOL), $61,326/quality-adjusted life-years (QALYs), and $9930/yr free of a major complication. If the biographer ceased to be effective after age 17, the cost per QALY would increase to $103,178/QALY gained. CONCLUSIONS: Preliminary analysis of the cost-effectiveness of use of the GlucoWatch Biographer in diabetes management is encouraging. Definitive analysis will require confirmation in other studies and populations.

Adolescent↗

Reduced hypoglycemic episodes and improved glycemic control in children with type 1 diabetes using insulin glargine and neutral protamine Hagedorn insulin.

OBJECTIVE: The purpose of this study was to evaluate the use of a new long-acting basal insulin, insulin glargine (IG), in children with type 1 diabetes. Study design Data from 114 subjects, age 2 to 18 years (mean, 12.2 years; 54 boys, 60 girls), were collected for 9 months before and 9 months after IG treatment. During IG therapy, all subjects received morning neutral protamine Hagedorn insulin (given with insulin lispro; Humalog) to provide daytime insulin coverage. The numbers of nonsevere and severe hypoglycemic events, hemoglobin A1c values, body weight, and daily insulin dose were recorded at each clinic visit. RESULTS: The mean (+/-1 SEM) frequency of nonsevere hypoglycemic events per week decreased from 2.0+/-0.1 to 1.3+/-0.1 (P<.001). Severe hypoglycemic episodes were reduced from a total of 22 in the 9 months before IG to nine in the 9 months after IG. Severe nocturnal events were similarly reduced from 14 to four episodes. The mean (+/-1 SEM) hemoglobin A1c levels were 9.6+/-0.1% (baseline), 9.4+/-0.1% at 3 months (P=.18), 9.3+/-0.1% at 6 months (P=.03), and 9.3+/-0.1% at 9 months (P=.01). CONCLUSION: Insulin glargine therapy can reduce hypoglycemic episodes in children and adolescents with suboptimal glucose control without jeopardizing glycemic control.

Adolescent↗

Use of the GlucoWatch biographer in children with type 1 diabetes.

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 < or =70 mg/dL (3.9 mmol/L) or > 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.

Adolescent↗

In utero dietary exposures and risk of islet autoimmunity in children.

OBJECTIVE: The goal of this study was to examine whether maternal dietary intake of vitamin D, omega-3 fatty acids, and omega-6 fatty acids during pregnancy is associated with the appearance of islet autoimmunity (IA) in offspring. RESEARCH DESIGN AND METHODS: The Diabetes Autoimmunity Study in the Young (DAISY) is recruiting at birth and following children at increased risk for type 1 diabetes, as determined by HLA-DR genotype or by family history of type 1 diabetes. A total of 233 mothers of newly recruited DAISY subjects were asked to recall their intake of food and nutritional supplements during the third trimester of pregnancy using the Willett food frequency questionnaire. Children were followed for an average of 4 years (range 0.8-7.3 years) for the appearance of insulin, GAD(65), and IA-2 autoantibodies. Sixteen children developed at least one autoantibody during this period. Unadjusted and adjusted hazard ratios (HRs) for the development of IA were estimated with survival analysis using a Weibull distribution. RESULTS: Maternal intake of vitamin D via food was significantly associated with a decreased risk of IA appearance in offspring, independent of HLA genotype, family history of type 1 diabetes, presence of gestational diabetes mellitus, and ethnicity (adjusted HR = 0.37; 95% CI 0.17-0.78). Vitamin D intake via supplements, omega-3 fatty acids, and omega-6 fatty acids intake during pregnancy were not associated with appearance of IA in offspring. CONCLUSIONS: Our findings suggest that maternal intake of vitamin D through food during pregnancy may have a protective effect on the appearance of IA in offspring.

Adult↗

Modem transmission of glucose values reduces the costs and need for clinic visits.

OBJECTIVE: To determine whether modem technology allows for effective management of type 1 diabetes when used in lieu of a clinic visit. RESEARCH DESIGN AND METHODS: A total of 70 adolescent patients with diabetes were prospectively randomized to either a control group or a modem group. Control group patients continued the standard of care of quarterly clinic visits, and modem group patients were instructed to transmit blood glucose data every 2 weeks for 6 months instead of a usual quarterly clinic visit. Health care providers analyzed the data received by modem and contacted patients to discuss diabetes treatment changes. GHbA(1c) levels were determined at 0 and 6 months, and the number of high and low blood glucose levels and adverse events were tracked. Clinic visit costs, patient expenses, and health care provider times were tracked for cost analysis for both groups. RESULTS: A total of 63 patients (33 control, 30 modem) completed the 6-month study. The GHbA(1c) values significantly decreased in both groups, with no statistically significant difference between groups (P = 0.96). The occurrence of mild-to-moderate hypoglycemic events were similar in the two groups, and there were no severe hypoglycemic events. The average cost of care for a clinic visit was $305.00, whereas the cost for 6 months of modem transmission was $163.00. CONCLUSIONS: This study shows that electronic transmission of blood glucose levels and other diabetes data every 2 weeks-in lieu of a clinic visit-results in a similar level of glucose control and incidence of acute diabetes complications when compared with current standard care.

Adolescent↗

Predictors of acute complications in children with type 1 diabetes.

CONTEXT: Diabetic ketoacidosis and severe hypoglycemia are acute complications of type 1 diabetes that are related, respectively, to insufficient or excessive insulin treatment. However, little is known about additional modifiable risk factors. OBJECTIVE: To examine the incidence of ketoacidosis and severe hypoglycemia in children with diabetes and to determine the factors that predict these complications. DESIGN, SETTING, AND PARTICIPANTS: A cohort of 1243 children from infancy to age 19 years with type 1 diabetes who resided in the Denver, Colo, metropolitan area were followed up prospectively for 3994 person-years from January 1, 1996, through December 31, 2000. MAIN OUTCOME MEASURES: Incidence of ketoacidosis leading to hospital admission or emergency department visit and severe hypoglycemia (loss of consciousness, seizure, or hospital admission or emergency department visit). RESULTS: The incidence of ketoacidosis was 8 per 100 person-years and increased with age in girls (4 per 100 person-years in < 7; 8 in 7-12; and 12 in > or =13 years; P<.001 for trend). In multivariate analyses, sex-adjusted and stratified by age (<13 vs > or =13 years), the risk of ketoacidosis in younger children increased with higher hemoglobin A(1c) (HbA(1c)) (relative risk [RR], 1.68 per 1% increase; 95% confidence interval [CI], 1.45-1.94) and higher reported insulin dose (RR, 1.40 per 0.2 U/kg per day; 95% CI, 1.20-1.64). In older children, the risk of ketoacidosis increased with higher HbA(1c) (RR, 1.43; 95% CI, 1.30-1.58), higher reported insulin dose (RR, 1.13; 95% CI, 1.02-1.25), underinsurance (RR, 2.18; 95% CI, 1.65-2.95), and presence of psychiatric disorders (for boys, RR, 1.59; 95% CI, 0.96-2.65; for girls, RR, 3.22; 95% CI, 2.25-4.61). The incidence of severe hypoglycemia was 19 per 100 person-years (P<.001 for trend) and decreased with age in girls (24 per 100 patient-years in < 7, 19 in 7-12, and 14 in > or =13 years). In younger children, the risk of severe hypoglycemia increased with diabetes duration (RR, 1.39 per 5 years; 95% CI, 1.16-1.69) and underinsurance (RR, 1.33; 95% CI, 1.08-1.65). In older children, the risk of severe hypoglycemia increased with duration (RR, 1.34; 95% CI, 1.25-1.51), underinsurance (RR, 1.42; 95% CI, 1.11-1.81), lower HbA(1c) (RR, 1.22; 95% CI, 1.12-1.32), and presence of psychiatric disorders (RR, 1.56; 95% CI, 1.23-1.98). Eighty percent of episodes occurred among the 20% of children who had recurrent events. CONCLUSIONS: Some children with diabetes remain at high risk for ketoacidosis and severe hypoglycemia. Age- and sex-specific incidence patterns suggest that ketoacidosis is a challenge in adolescent girls while severe hypoglycemia continues to affect disproportionally the youngest patients and boys of all ages. The pattern of modifiable risk factors indicates that underinsured children and those with psychiatric disorders or at the extremes of the HbA(1c) distribution should be targeted for specific interventions.

Acute Disease↗

Use of the GlucoWatch biographer in children and adolescents with diabetes.

OBJECTIVE: This study was done to evaluate the accuracy and safety of measuring glucose with the GlucoWatch biographer in children and adolescents with diabetes. METHODS: Accuracy was assessed by comparing biographer glucose measurements with hourly blood glucose measurements using the HemoCue (Aktiebolaget Leo, Helsingborg, Sweden) Photometer for up to 12 h of monitoring. Safety was evaluated by examining the biographer application sites immediately upon removal of the devices, and then at regular intervals. RESULTS: Sixty-six subjects each wore three biographers at sites including the forearm, upper arm, leg, and torso. For forearm biographers, the mean absolute relative difference between biographer readings and blood glucose was 21%. Ninety-five per cent of biographer readings fell into the A or B regions of the Clarke error grid, and 97.3% into the A or B regions of the consensus error grid. Data from biographers worn at the alternative sites were similar to data from the forearm biographers. Two strong reactions to the adhesive pad of the biographer AutoSensor were observed. Most skin reactions were mild. CONCLUSIONS: The GlucoWatch biographer is well tolerated by children and adolescents with diabetes. Performance is similar when the device is worn at different anatomical sites, and is similar to the performance on the forearm, previously reported in adults.

Journal Article↗