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Objective: To determine the individual persistence of the relationship between mean sensor glucose (MG) concentrations and hemoglobin A(1c) (A1C) from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring (CGM) Randomized Trial., Research Design and Methods: MG was calculated using CGM data for 3 months before A1C measurements at 3, 6, 9, and 12 months for the CGM group and at 9 and 12 months for the control group. An MG-to-A1C ratio was included in analysis for subjects who averaged ≥4 days/week of CGM use., Results: Spearman correlations of the MG-to-A1C ratio between consecutive visits 3 months apart ranged from 0.70 to 0.79. The correlations for children and youth were slightly smaller than those for adults. No meaningful differences were observed by device type or change in A1C., Conclusions: Individual variations in the rate of hemoglobin glycation are persistent and contribute to the inaccuracy in estimating MGs calculated from A1C levels.

Objective: Identify factors predictive of severe hypoglycemia (SH) and assess the clinical utility of continuous glucose monitoring (CGM) to warn of impending SH., Research Design and Methods: In a multicenter randomized clinical trial, 436 children and adults with type 1 diabetes were randomized to a treatment group that used CGM (N = 224), or a control group that used standard home blood glucose monitoring (N = 212) and completed 12 months of follow-up. After 6 months, the original control group initiated CGM while the treatment group continued use of CGM for 6 months. Baseline risk factors for SH were evaluated over 12 months of follow-up using proportional hazards regression. CGM-derived indices of hypoglycemia were used to predict episodes of SH over a 24-h time horizon., Results: The SH rate was 17.9 per 100 person-years, and a higher rate was associated with the occurrence of SH in the prior 6 months and female sex. SH frequency increased eightfold when 30% of CGM values were ≤ 70 mg/dL on the prior day (4.5 vs. 0.5%; P < 0.001), but the positive predictive value (PPV) was low (<5%). Results were similar for hypoglycemic area under the curve and the low blood glucose index calculated by CGM., Conclusions: SH in the 6 months prior to the study was the strongest predictor of SH during the study. CGM-measured hypoglycemia over a 24-h span is highly associated with SH the following day (P < 0.001), but the PPV is low.

Aims: To identify psychosocial factors associated with the use of continuous glucose monitoring by adults with Type 1 diabetes., Methods: Twenty adult patients (aged 45 +/- 15 years, diabetes duration 25 +/- 19 years, 50% female) followed at our site in the multi-centre Juvenile Diabetes Research Foundation continuous glucose monitoring trial were divided into three groups: Glycated haemoglobin (HbA(1c)) Responders who demonstrated an improvement in glycaemic control with continuous glucose monitoring (baseline HbA(1c)> or = 7.0%, HbA(1c) reduction greater than or equal to 0.5%), Hypoglycaemia Responders (baseline HbA(1c) < 7.0%) who demonstrated decreased time < 3.9 mmol/l while remaining within target HbA(1c), and HbA(1c) Non-Responders (baseline HbA(1c)> or = 7.0%, HbA(1c) reduction less than 0.5%). Subjects participated in semi-structured interviews focusing on their psychosocial experiences with continuous glucose monitoring., Results: Three major themes were identified that differentiated Responders (including both the HbA(1c) and Hypoglycaemia groups) from Non-Responders: (i) coping with frustrations-Responders used self-controlled rather than emotions-based coping when faced with continuous glucose monitoring frustrations; (ii) use of information-Responders used retrospective pattern analysis, not just minute-by-minute data analysis, in glycaemic management; (iii) 'significant other'/spousal involvement-Responders endorsed interest, encouragement and participation by their loved ones. Both Responders and Non-Responders expressed body image concerns when wearing continuous glucose monitoring devices., Conclusions: This qualitative study points to the importance of coping skills, retrospective review of data, and 'significant other' involvement in the effective use of continuous glucose monitoring. These findings will inform clinical initiatives to improve patient selection and training in the use of this new technology and have served as the basis for development of quantitative surveys to be used in clinical practice.

In recent years continuous subcutaneous insulin infusion pumps have become widely adopted in many parts of the world in the treatment of type 1 diabetes in adults. A comprehensive summary of all aspects of pump therapy is beyond the scope of this article, and in this review we will focus on several practical issues that in our experience are of clinical importance in the care of patients using insulin pumps. These include: benefits and risks of pump therapy, including the use of pumps to limit hypoglycemia; individual patient considerations in choosing between pump therapy and multiple daily injections; common pump-specific etiologies of erratic glucose control, including routine clinical practices that can assist with the detection of these problems; and the use of different pump bolus types for prandial insulin coverage.

Objective: To evaluate long-term effects of continuous glucose monitoring (CGM) in intensively treated adults with type 1 diabetes., Research Design and Methods: We studied 83 of 86 individuals >or=25 years of age with type 1 diabetes who used CGM as part of a 6-month randomized clinical trial in a subsequent 6-month extension study. RESULTS After 12 months, median CGM use was 6.8 days per week. Mean change in A1C level from baseline to 12 months was -0.4 +/- 0.6% (P < 0.001) in subjects with baseline A1C >or=7.0%. A1C remained stable at 6.4% in those with baseline A1C <7.0%. The incidence rate of severe hypoglycemia was 21.8 and 7.1 events per 100 person-years in the first and last 6 months, respectively. Time per day with glucose levels in the range of 71-180 mg/dl increased significantly (P = 0.02) from baseline to 12 months., Conclusions: In intensively treated adults with type 1 diabetes, CGM use and benefit can be sustained for 12 months.

Objective: To evaluate factors associated with successful use of continuous glucose monitoring (CGM) among participants with intensively treated type 1 diabetes in the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Randomized Clinical Trial., Research Design and Methods: The 232 participants randomly assigned to the CGM group (165 with baseline A1C >or=7.0% and 67 with A1C <7.0%) were asked to use CGM on a daily basis. The associations of baseline factors and early CGM use with CGM use >or=6 days/week in the 6th month and with change in A1C from baseline to 6 months were evaluated in regression models., Results: The only baseline factors found to be associated with greater CGM use in month 6 were age >or=25 years (P < 0.001) and more frequent self-reported prestudy blood glucose meter measurements per day (P < 0.001). CGM use and the percentage of CGM glucose values between 71 and 180 mg/dl during the 1st month were predictive of CGM use in month 6 (P < 0.001 and P = 0.002, respectively). More frequent CGM use was associated with a greater reduction in A1C from baseline to 6 months (P < 0.001), a finding present in all age-groups., Conclusions: After 6 months, near-daily CGM use is more frequent in intensively treated adults with type 1 diabetes than in children and adolescents, although in all age-groups near-daily CGM use is associated with a similar reduction in A1C. Frequency of blood glucose meter monitoring and initial CGM use may help predict the likelihood of long-term CGM benefit in intensively treated patients with type 1 diabetes of all ages.

OBJECTIVE The potential benefits of continuous glucose monitoring (CGM) in the management of adults and children with well-controlled type 1 diabetes have not been examined. RESEARCH DESIGN AND METHODS A total of 129 adults and children with intensively treated type 1 diabetes (age range 8-69 years) and A1C <7.0% were randomly assigned to either continuous or standard glucose monitoring for 26 weeks. The main study outcomes were time with glucose level < or =70 mg/dl, A1C level, and severe hypoglycemic events. RESULTS At 26 weeks, biochemical hypoglycemia (< or =70 mg/dl) was less frequent in the CGM group than in the control group (median 54 vs. 91 min/day), but the difference was not statistically significant (P = 0.16). Median time with a glucose level < or =60 mg/dl was 18 versus 35 min/day, respectively (P = 0.05). Time out of range (< or =70 or >180 mg/dl) was significantly lower in the CGM group than in the control group (377 vs. 491 min/day, P = 0.003). There was a significant treatment group difference favoring the CGM group in mean A1C at 26 weeks adjusted for baseline (P < 0.001). One or more severe hypoglycemic events occurred in 10 and 11% of the two groups, respectively (P = 1.0). Four outcome measures combining A1C and hypoglycemia data favored the CGM group in comparison with the control group (P < 0.001, 0.007, 0.005, and 0.003). CONCLUSIONS Most outcomes, including those combining A1C and hypoglycemia, favored the CGM group. The weight of evidence suggests that CGM is beneficial for individuals with type 1 diabetes who have already achieved excellent control with A1C <7.0%.

Background: The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined., Methods: In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks., Results: The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference., Conclusions: Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.), (2008 Massachusetts Medical Society)

Continuous glucose monitoring (CGM) is an evolving technology poised to redefine current concepts of glycemic control and optimal diabetes management. To date, there are few randomized studies examining how to most effectively use this new tool. Therefore, a group of eight diabetes specialists heard presentations on continuous glucose sensor technology and then discussed their experience with CGM in order to identify fundamental considerations, objectives, and methods for applying this technology in clinical practice. The group concluded that routine use of CGM, with real-time data showing the rate and direction of glucose change, could revolutionize current approaches to evaluating and managing glycemia. The need for such progress is indicated by the growing prevalence of inadequately treated hyperglycemia. Coordinating financial and educational resources and developing clear protocols for using glucose sensor technology are urgent priorities in promoting wide adoption of CGM by patients and health care providers. Finally, researchers, manufacturers, payers, and advocacy groups must join forces on the policy level to create an environment conducive to managing continuous data, measuring outcomes, and formalizing best practices.

Real-time continuous glucose monitoring (RT-CGM) devices provide detailed information on glucose patterns and trends, and alarms that alert the patient to both hyper- and hypoglycemia. This technology can dramatically improve the day-to-day management of patients with diabetes and promises to be a major advance in diabetes care. The safe and effective use of RT-CGM in diabetes management rests on an understanding of several physiological as well as technological issues. This article outlines the key issues that should be addressed in the training curriculum for patients starting on RT-CGM: (1) physiologic lag between interstitial and blood glucose levels and the implications for device calibration, and interpretation and use of data in diabetes management; (2) practical considerations with the use of sensor alarms and caveats in the setting of alarm thresholds; and (3) potential risk for hypoglycemia related to excessive postprandial bolusing by RT-CGM users, and the practical implications for patient training.

Objective: The purpose of this study was to identify psychosocial issues related to diabetes, approaches to self-care, self-perceptions, and social interactions among insulin pump users with type 1 diabetes., Research Design and Methods: Adult insulin pump users participated in focus groups loosely formed on the basis of A1C level. Transcripts of focus group meetings were coded into themes by five reviewers using NVivo2 qualitative software., Results: Thirty adults with long-term diabetes participated in five focus groups: two with low mean +/-SD A1C (6.8 +/- 0.4%), one with mid A1C (7.80 +/- 0.3%), and two with high A1C (9.1 +/- 0.5%). Three major themes were identified: impact on diabetes self-care, emotional reactions to the insulin pump, body image, and social acceptance. Participants who described the pump as a tool to meet glycemic goals also described a more active approach to diabetes and had better glycemic control; those who discussed the pump as a panacea described more passive self-care and had poorer glycemic control. Low A1C groups reported that starting the insulin pump reminded them of feelings they experienced at their initial diabetes diagnosis, whereas the high A1C groups did not report these feelings. Women were more concerned than men about body image and social acceptance with pump use., Conclusions: Active participation in self-care, realistic expectations of pump use, and emotional recall of diabetes diagnosis were associated with better glycemic control. Interventions to improve diabetes management with pump use should include evaluation and discussion of active versus passive approaches to self-care, recall of diabetes diagnosis, expectations of the pump, and pump-related self-consciousness and body image concerns. The roles of these factors in optimal diabetes management warrant further investigation.

Past cross-sectional studies have suggested that young adults with insulin-dependent (Type 1) diabetes mellitus (IDDM) may experience problems in their close peer relationships. For 10 years, we have followed an onset cohort of children and adolescents with IDDM (n = 57) and an age-matched group who were originally recruited after an acute illness, accident, or injury (n = 54). Now aged 19-26 years, these two groups were compared in terms of their friendship patterns, dating and love experiences, and sense of loneliness. All subjects in both groups had at least one friend. However, the IDDM group reported fewer friendships overall. The difference was accounted for by the number of less intimate friends. The two groups had similar frequencies of current romantic partners (IDDM = 63%; comparison group = 64%). While dating attitude and dating assertiveness did not differ between groups, some differences were found in terms of experiences of a primary love relationship. IDDM patients experienced less trust and sense of intimate friendship in these love relationships. No differences in loneliness were found. The preponderance of our findings indicate that the two groups had similar patterns and experiences of close peer relationships. Thus, the study does not suggest that IDDM leads to serious problems in forming social relationships for these patients during the transition to young adulthood. On the other hand, the IDDM patients' lower level of trust and intimacy within love relationships are consistent with other findings from this study suggesting specific areas of lowered self-worth that appear in social relationships.