Initiation Of Continuous Glucose Monitoring Research Articles

955-P: Evaluating Early Initiation of Continuous Glucose Monitoring (CGM) among Youth Diagnosed with Type 1 Diabetes (T1D)

Background: CGM has glycemic and psychosocial benefits. The current study sought to evaluate the specific impact of introducing CGM soon after diagnosis of T1D. Methods: A sample of 55 youth recently diagnosed with T1D were randomized to either an intervention (start Dexcom G5 CGM within 1 month of diagnosis) or control (monthly blinded CGM use) condition. HbA1c data and youth and parent surveys were collected at baseline, 13 and 26 weeks and glucose levels were measured via blinded or unblinded CGM. T-tests were used to compare groups based on glycemic and psychosocial outcomes. Results: Participant ages ranged from 3-18 (mean 11.1 ± 3.6years). On average, youth in the intervention group spent less time in hypoglycemia at 13 (2.0% vs. 7.5%, p=0.002) and 26 (1.9% vs. 4.9%, p=0.056) weeks and had elevated scores on the Diabetes Self Management Profile at week 13 (54.5 vs. 43.9 p=0.021) and more openness with glucose monitoring at weeks 13 (15.0 vs. 12.2, p=0.057) and 26 (16.42 vs. 12.12, p=0.014). Conversely, intervention group youth reported worse quality of life (QoL) at 13 weeks (8.5 vs. 3.0, p=0.020). At 26 weeks, the intervention group had slightly higher diabetes distress among youth (32.2 vs. 25.4, p=0.089) but lower diabetes distress among parents (42.5 vs. 50.9, p=0.050). Adding to prior reports from this study, these results show reduced hypoglycemia, improved attitudes toward diabetes technology, and satisfaction with glucose monitoring as well as decreased parent reported youth QoL. Conclusion: Introducing CGM soon after diagnosis appears to have substantial benefits, including prevention of hypoglycemia and bolstering youth self-management practices and openness to glucose monitoring. Given that early CGM initiation may negatively impact QoL in youth with T1D, as indicated by both youth and parent report, youth with T1D may benefit from education around use of CGM as well as psychosocial support for those with lower QoL. Disclosure J.J. Wong: None. S. Clay: None. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. S. Hanes: None. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Beta Bionics, MannKind Corporation, Novo Nordisk Inc., Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Other Relationship; Self; Dexcom, Inc. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. Funding Dexcom, Inc.

Long-Term Effects of Initiating Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitoring (CGM) in People with Type 1 Diabetes and Unsatisfactory Diabetes Control.

Background: We aimed to assess the long-term effects of the introduction of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in people with type 1 diabetes (T1D). Methods: A prospective single-centre cohort study including participants with T1D and HbA1c > 7.5%. After completing a course in flexible intensified insulin treatment (FIT), participants were offered treatment change to CSII/CGM. FIT participants with HbA1c ≤ 7.5% who remained on multiple daily injections (MDI) and without CGM were monitored as a separate cohort to compare the cumulative incidence of diabetic complications. Results: The study cohort included 41 participants with T1D (21 male/20 female). The mean age (±SD) at inclusion was 24.2 ± 10.9 years, the mean follow-up was 8.9 ± 2.8 years, and the mean diabetes duration at the end of the study was 15.9 ± 10.1 years. The mean HbA1c level before the introduction of CSII was 8.8 ± 1.3% (73 ± 8 mmol/mol), and decreased significantly thereafter to 8.0 ± 1.1% (63 ± 7 mmol/mol) (p = 0.0001), and further to 7.6 ± 1.1% (59 ± 11 mmol/mol) after the initiation of CGM (p = 0.051). In the MDI group the HbA1c levels did not change significantly during a mean follow-up of 6.8 ± 3.2 years. The frequency of severe hypoglycaemia after the introduction of CSII/CGM declined significantly (from 9.7 to 2.2 per 100 patient-years, p = 0.03), and the cumulative incidence of newly diagnosed diabetic microvascular complications were comparable between the study group and the observational cohort. Conclusion: In people with T1D and unsatisfactory diabetes control the introduction of CSII and CGM results in a substantial and long-term improvement.

Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes.

We investigated the efficacy and safety of continuous glucose monitoring (CGM) initiation within 1 year of type 1 diabetes (T1D) diagnosis among children, adolescents, and adults. Differences in mean A1c (primary outcome) and diabetes-related emergency visits (secondary outcome) for 2.5 years between early CGM users and non-CGM users were studied among 396 newly diagnosed patients with T1D (94% children [age <18 years], 5% adults, 46% females) between January 2013 and December 2015 at Barbara Davis Center for Diabetes. The primary outcome was adjusted by age at diagnosis and gender. P < 0.05 was considered significant. Gender, ethnicity, body mass index, and A1c at diagnosis were similar between the groups. Irrespective of insulin delivery methods, CGM users had a significantly greater improvement in glycemic control than non-CGM users at 1, 1.5, 2, and 2.5 years. For 2.5 years of follow-up, the multiple daily injection (MDI)+CGM group (n = 19) had 1.5% ± 0.2% lower A1c than the MDI only group (n = 225) (7.7% ± 0.2% vs. 9.2% ± 0.04%, P < 0.0001), and the insulin pump (continuous subcutaneous insulin infusion [CSII])+CGM group (n = 62) had 0.7% ± 0.1% lower A1c than the CSII only group (n = 90) (8.0% ± 0.08% vs. 8.7% ± 0.07%, P < 0.0001). The MDI+CGM group had significantly lower A1c than the CSII only group (7.7% ± 0.2% vs. 8.7% ± 0.07%, P < 0.0001). The number of diabetes-related (severe hypoglycemia or hyperglycemia) emergency department visits was significantly lower among early CGM users compared with non-CGM users (P = 0.003). Irrespective of insulin delivery system, early initiation of CGM within 1 year from T1D diagnosis was associated with better glucose control and fewer diabetes-related emergency visits.

Continuous glucose monitoring use and glucose variability in pre-school children with type 1 diabetes

AimsThe objective of this nationwide population-based cohort study was to evaluate the correlation between continuous glucose monitoring (CGM) use and glucose variability in pre-schoolers with type 1 diabetes. MethodsWe analysed data from the Slovenian National Registry. The primary endpoint was the difference in glucose variability between periods, during which participants were using CGM and periods, during which CGM was not used, over 5 years. ResultsA total of 40 children <8 years old were followed for an estimated observational period of 116 patient/years. Mean age at CGM initiation was 3.5 (±1.7) years. Both standard deviation of mean glucose [3.6 mmol/L (3.2–3.9) with CGM and 4.3 mmol/L (3.8–4.7) without CGM, p < 0.001] and coefficient of variation [44.0% (40.4–47.0) with CGM and 46.1% (42.3–49.4) without CGM, p = 0.021] were lower during the periods, when CGM was used. Frequent CGM use (>5 days/week) was associated with a 0.4% [4.4 mmol/mol] reduction in glycated haemoglobin level (7.6% compared to 7.2%, p = 0.047). ConclusionsOur results indicate that the use of CGM was associated with reduced glucose variability during a 5 year follow-up period among pre-schoolers with type 1 diabetes. Trial RegistrationClinicaltrials.gov: NCT-03293082.

Healthcare Resource Waste Associated with Patient Nonadherence and Early Discontinuation of Traditional Continuous Glucose Monitoring in Real-World Settings: A Multicountry Analysis.

Background: Traditional continuous glucose monitoring (CGM) provides detailed information on glucose patterns and trends to inform daily diabetes management decisions, which is particularly beneficial for patients with a history of hypoglycemia unawareness. However, a high level of patient adherence (≥70%) is required to achieve clinical benefits. The aim of this study was to assess the impact of real-world patient nonadherence and early discontinuation on healthcare resource use.Methods: A cost calculator was designed to evaluate monthly healthcare resource waste within the first year of traditional CGM initiation by combining estimates of real-world nonadherence and early discontinuation from the literature with the wholesale acquisition costs of the current technology in the United States (for a commercial payer and for Medicare), or its equivalent in Sweden, Germany, or the Netherlands.Results: Based on an early discontinuation rate of 27% and nonadherence rates of 13.9%–31.1% over the 12 months following initiation, the healthcare resource waste associated with nonadherence and early discontinuation was $220,289 and $21,775, respectively, for every 100 patients initiating CGM in the U.S. commercial payer scenario. In the Medicare scenario, the corresponding figures were $72,648 and $5,675, respectively. In both scenarios, nonadherence and early discontinuation accounted for ∼24% of resources being wasted within the first year of CGM initiation. Similar results were observed using the local costs in the other countries analyzed.Conclusions: The healthcare resource waste associated with traditional CGM nonadherence and early discontinuation warrants deliberate consideration when selecting suitable patients for this technology.

Baseline Psychosocial Characteristics Predict Frequency of Continuous Glucose Monitoring in Youth with Type 1 Diabetes.

Consistent use of continuous glucose monitoring (CGM) has been associated with improved glycemic control in youth with type 1 diabetes (T1D). There are many barriers to device uptake and continued use. There is a need to understand patient-specific characteristics when considering CGM. We evaluated patterns of CGM use and associations between baseline psychosocial measures and frequency of CGM use over 1 year. Youth with T1D (n = 120), ages 8-18 years, completed questionnaires at CGM initiation and after 6 and 12 months assessing depressive symptoms, diabetes burden, and diabetes-specific and generic quality of life (QOL). Youth (51% male and 95% white) had mean age 12.7 ± 2.7 years, diabetes duration 6.1 ± 3.6 years, and glycated hemoglobin (HbA1c) 8.0 ± 0.8%. Over 1 year, 35% of youth used CGM 6 to 7 days per week, 45% used CGM 3-5 days per week, and 20% used CGM only 0-2 days per week. Youth who used CGM 3-7 days per week over 12 months had lower HbA1c at months 9 and 12 than youth who used CGM 0-2 days per week (9 months: 7.9 ± 0.9% vs. 8.5 ± 1.1%, P = 0.006 and 12 months: 8.0 ± 0.9% vs. 8.5 ± 1.1%, P = 0.02). Those using CGM 0-2 days per week had greater endorsement of depressive symptoms and diabetes burden and reported lower QOL at baseline compared with those using CGM 3-7 days per week. CGM use for 3 or more days per week over 12 months had a protective effect on HbA1c. Providers should consider addressing psychosocial parameters when initiating CGM to maximize uptake and promote continued use in youth with T1D.

Insulin Pump and Continuous Glucose Monitor Initiation in Hospitalized Patients with Type 2 Diabetes Mellitus.

Insulin pumps and continuous glucose monitoring (CGM) are commonly used by patients with diabetes mellitus in the outpatient setting. The efficacy and safety of initiating inpatient insulin pumps and CGM in the nonintensive care unit setting is unknown. In a prospective pilot study, inpatients with type 2 diabetes were randomized to receive standard subcutaneous basal-bolus insulin and blinded CGM (group 1, n = 5), insulin pump and blinded CGM (group 2, n = 6), or insulin pump and nonblinded CGM (group 3, n = 5). Feasibility, glycemic control, and patient satisfaction were evaluated among groups. Group 1 had lower mean capillary glucose levels, 144.5 ± 19.5 mg/dL, compared with groups 2 and 3, 191.5 ± 52.3 and 182.7 ± 59.9 mg/dL (P1 vs. 2+3 = 0.05). CGM detected 19 hypoglycemic episodes (glucose <70 mg/dL) among all treatment groups, compared with 12 episodes detected by capillary testing, although not statistically significant. No significant differences were found for the total daily dose of insulin or percentage of time spent below target glucose range (<90 mg/dL), in target glucose range (90-180 mg/dL), or above target glucose range (>180 mg/dL). On the Diabetes Treatment Satisfaction Questionnaire-Change, group 3 reported increased hyperglycemia and decreased hypoglycemia frequency compared with the other two groups, although the differences did not reach statistical significance. Insulin pump and CGM initiation are feasible during hospitalization, although they are labor intensive. Although insulin pump initiation may not lead to improved glycemic control, there is a trend toward CGM detecting a greater number of hypoglycemic episodes. Larger studies are needed to determine whether use of this technology can lower inpatient morbidity and mortality.

Continuous Glucose Monitoring for Hypoglycemia Avoidance and Glucose Counterregulation in Long-Standing Type 1 Diabetes.

Patients with long-standing type 1 diabetes (T1D) are at increased risk for severe hypoglycemia because of defects in glucose counterregulation and recognition of hypoglycemia symptoms, in part mediated through exposure to hypoglycemia. To determine whether implementation of real-time continuous glucose monitoring (CGM) as a strategy for hypoglycemia avoidance could improve glucose counterregulation in patients with long-standing T1D and hypoglycemia unawareness. Eleven patients with T1D disease duration of ∼31 years were studied longitudinally in the Clinical & Translational Research Center of the University of Pennsylvania before and 6 and 18 months after initiation of CGM and were compared with 12 nondiabetic control participants. Endogenous glucose production response derived from paired hyperinsulinemic stepped-hypoglycemic and euglycemic clamps with infusion of 6,6-2H2-glucose. In patients with T1D, hypoglycemia awareness (Clarke score) and severity (HYPO score and severe events) improved (P < 0.01 for all) without change in hemoglobin A1c (baseline, 7.2% ± 0.2%). In response to insulin-induced hypoglycemia, endogenous glucose production did not change from before to 6 months (0.42 ± 0.08 vs 0.54 ± 0.07 mg·kg-1·min-1) but improved after 18 months (0.84 ± 0.15 mg·kg-1·min-1; P < 0.05 vs before CGM), albeit remaining less than in controls (1.39 ± 0.11 mg·kg-1·min-1; P ≤ 0.01 vs all). Real-time CGM can improve awareness and reduce the burden of problematic hypoglycemia in patients with long-standing T1D, but with only modest improvement in the endogenous glucose production response that is required to prevent or correct low blood glucose.

The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics.

BackgroundContinuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.Methods/DesignThe CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014.DiscussionThe CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes.Trial registrationClinicalTrial.gov NCT01295788. Registered 14 February 2011.

Sidebar: Hospital-Based Self-Management of Diabetes

Mission Hospital is an 800-bed, not-for-profit, independent community hospital system located in Asheville, North Carolina. The Health Education Center, an outpatient program of Mission, includes the Diabetes Center, which is accredited through the American Diabetes Association. The Diabetes Center has a sister diabetes program at McDowell Hospital, in Marion, North Carolina, that provides diabetes education for adults in that region. For patients with or at risk for diabetes, one of the advantages conferred by the Diabetes Center’s relationship with Mission Hospital is that the center shares the hospital’s mission of serving all individuals in western North Carolina and the surrounding region. A second advantage is that the Health Education Center has the financial backing to conduct yearly community programs to reach underserved and minority populations, with no charge to the participants. The events serve 100-300 people each year and include screening for hyperglycemia, measurement of high blood pressure, and calculation of body mass index. Education in the areas of basic diabetes pathophysiology, nutrition, and exercise is provided by certified diabetes educators and physicians. Participants also receive healthy snacks and recipes and are given blood glucose meters and taught how to use them. Mission sees value in educating health professionals about diabetes. Since 2000, Mission, along with the Mountain Area Health Education Center and other community and regional organizations, has planned and held an annual professional diabetes clinical workshop for medical, nursing, pharmacy, and nutrition professionals. This workshop reaches 180-250 health professionals per year and covers the most up-to-date research and trends in diabetes care. Twenty-four percent of inpatients discharged from Mission have a diagnosis of diabetes or hyperglycemia. Two years ago, Mission started a diabetes-resource program for nurses. This is a comprehensive diabetes education program for bedside nurses, who, by expanding their knowledge base, are thus better equipped to provide education about diabetes-associated survival skills to inpatients with diabetes. Part of this training is to reinforce the importance of ensuring that patients receive a referral to outpatient diabetes selfmanagement training at the time of discharge, either at one of Mission’s diabetes centers or at another outpatient education center in the region. Another advantage of being based in a hospital system is that patients can receive care and services from a multidisciplinary team of professionals. Our outpatient diabetes education team includes an endocrinologist, who serves as our medical director, and 10 certified diabetes educators from the nursing, nutrition, and pharmacy professions. Our team also includes an exercise specialist and a clinical social worker. The ability to refer patients for multiple types of services within the same program is convenient for both patients and clinicians. Also, having professionals with multiple backgrounds available to discuss issues such as treatments, disease cases, and patient-related challenges is a tremendous advantage for the clinicians/educators. Having such a large team also enables us to offer comprehensive services, including diabetes self-care classes, an insulin pump course, a gestational diabetes course, medical nutrition therapy, initiation of continuous glucose monitoring, a program on pediatric diabetes, individual consultations for diabetes and nutrition education, diabetes support groups, and employersponsored disease management programs. Of note, patients participating in the disease management programs undergo long-term follow-up by our clinicians and are seen quarterly for clinical assessment, goal setting, monitoring, and drug therapy review. In this population, we have seen significant improvements in hemoglobin A1c and lipid levels, decreased per-patient medical costs, and reduced numbers of sick days. These services are not a significant source of revenue for Mission. Their value is instead found in the community-level health and wellness benefits they yield, as well as in the satisfaction exhibited by the patients who visit us and by the team of professionals available to care for them.

Benefits of Continuous Glucose Monitor Use in Clinical Practice

To determine the benefits of personal continuous glucose monitoring (CGM) outside of a controlled clinical trial in a single ambulatory diabetes clinic. In this retrospective study, we reviewed medical records of all patients who began CGM in our university-based clinical practice between July 2006 and October 2008. Data pertaining to 1 year before initiation of CGM through January 2009 were collected. All patient visits were performed by any 1 of 7 board-certified endocrinologists and/or 5 certified diabetes educators. A severe hypoglycemic event was considered to have occurred if the patient reported requiring assistance or losing consciousness, or if there was documentation from another source (eg, an emergency department visit). Analysis of the effect of CGM on hemoglobin A1c and occurrence of severe hypoglycemia was performed. A total of 117 patients initiated CGM between July 2006 and October 2008 and used CGM for at least 2 months (total experience on CGM, 1136 patient-months; average 9.7 months per patient). Mean age was 44.5 +/- 12.8 years (range, 14.3-71.7 years), and average duration of diabetes mellitus was 23.9 years. All patients were using insulin pumps before initiation of CGM, including 10 patients with type 2 diabetes. Sixty-eight patients (58%) had preexisting hypoglycemia unawareness. Average hemoglobin A1c level for 1 year before CGM initiation was 7.6 +/- 1.1%, and with CGM use it dropped to 7.2 +/- 0.8% (P<.001). Forty-two patients had severe hypoglycemic events in the year before CGM use or during CGM use. Overall, CGM use was associated with a significant decrease in the rate of severe hypoglycemic episodes (odds ratio, 0.40; 95% confidence interval, 0.24-0.65). Personal CGM, in a real-world setting, improves glucose control and reduces the rate of severe hypoglycemic episodes.

Benefits of Continuous Glucose Monitor Use in Clinical Practice

Objective To determine the benefits of personal con- tinuous glucose monitoring (CGM) outside of a controlled clinical trial in a single ambulatory diabetes clinic. Methods In this retrospective study, we reviewed medical records of all patients who began CGM in our university-based clinical practice between July 2006 and October 2008. Data pertaining to 1 year before initiation of CGM through January 2009 were collected. All patient visits were performed by any 1 of 7 board-certified endo- crinologists and/or 5 certified diabetes educators. A severe hypoglycemic event was considered to have occurred if the patient reported requiring assistance or losing conscious- ness, or if there was documentation from another source (eg, an emergency department visit). Analysis of the effect of CGM on hemoglobin A1c and occurrence of severe hypoglycemia was performed. Results A total of 117 patients initiated CGM between July 2006 and October 2008 and used CGM for at least 2 months (total experience on CGM, 1136 patient-months; average 9.7 months per patient). Mean age was 44.5 ± 12.8 years (range, 14.3-71.7 years), and average duration of dia- betes mellitus was 23.9 years. All patients were using insu- lin pumps before initiation of CGM, including 10 patients with type 2 diabetes. Sixty-eight patients (58%) had pre- existing hypoglycemia unawareness. Average hemoglobin A1c level for 1 year before CGM initiation was 7.6 ± 1.1%, and with CGM use it dropped to 7.2 ± 0.8% (P<.001). Forty-two patients had severe hypoglycemic events in the year before CGM use or during CGM use. Overall, CGM use was associated with a significant decrease in the rate of severe hypoglycemic episodes (odds ratio, 0.40; 95% confidence interval, 0.24-0.65). Conclusions Personal CGM, in a real-world setting, improves glucose control and reduces the rate of severe hypoglycemic episodes. (Endocr Pract. 2010;16:371-375)

Continuous Glucose Monitoring Technology for Personal Use

The purpose of this article is to describe the development and implementation of an educational program for the initiation of real-time continuous glucose monitoring (CGM) technology for personal use, not 3-day CGMS diagnostic studies. The education program was designed to meet the needs of patients managing their diabetes with either diabetes medications or insulin pump therapy in an outpatient diabetes education center using a team-based approach. Observational research, complemented by literature review, was used to develop an educational program model and teaching strategies. Diabetes educators, endocrinologists, CGM manufacturer clinical specialists, and patients with diabetes were also interviewed for their clinical observations and experience. The program follows a progressive educational model. First, patients learn in-depth about real-time CGM technology by attending a group presensor class that provides detailed information about CGM. This presensor class facilitates self-selection among patients concerning their readiness to use real-time CGM. If the patient decides to proceed with real-time CGM use, CGM initiation is scheduled, using a clinic-centered protocol for both start-up and follow-up. Successful use of real-time CGM involves more than just patient enthusiasm or interest in a new technology. Channeling patient interest into a structured educational setting that includes the benefits and limitations of real-time CGM helps to manage patient expectations.