Standard Blood Glucose Monitoring Research Articles

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. ClinicalTrials.gov Identifier: NCT03240432.

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes

Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. ClinicalTrials.gov Identifier: NCT03263494.

749-P: Parents’ Psychosocial Outcomes from the Strategies to Encourage New CGM Use in Early Childhood (SENCE) Trial at 12 Months

Objective: Parents of young children with type 1 diabetes report developmental and management challenges and diabetes-related distress. In the SENCE trial with children 2-&amp;lt;8 yrs, we described improved parental psychosocial outcomes from baseline to 26 wks when continuous glucose monitoring (CGM) was combined with a family behavioral intervention (FBI), compared to CGM alone and to standard blood glucose monitoring. We now explore psychosocial outcomes in the CGM+FBI and CGM alone groups over the extension phase (observation without intervention, 26 to 52 wks post-baseline). Method: Parents (N=143, children: 50% female, 68% non-Hispanic White, age=5.7±1.8 yrs, A1c=8.2±0.8%) completed validated surveys of diabetes burden, diabetes family impact, hypoglycemia fear, and treatment regimen impact at baseline, 26, and 52 wks. We analyzed 52 week outcomes using within-group t tests and between-group longitudinal models. Results: Survey scores were stable from 26 to 52 wks, although differences from baseline to 52 wks were not significant (p&amp;lt;.01) (Table). Conclusion: Introducing CGM with FBI improves parental psychosocial outcomes for at least 6 mos; the similar results at 12 mos suggest durability to 1 yr. Importantly, adding CGM to diabetes regimens in young children, especially with behavioral support, does not appear to add to parents’ perceived burden or fear of low blood glucose. Disclosure M.E. Hilliard: None. L. Kanapka: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US. B. Anderson: None. K. Miller: None. W. Levy: None. M.A. Van Name: None. P.V. Commissariat: None. L. DiMeglio: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Assessment of hypoglycemic status among hospitalized elderly patients with type 2 diabetes

To investigate the hypoglycemic characteristics of hospitalized elderly patients with type 2 diabetes mellitus (T2DM). From January, 2014 to December, 2015, the data of 58 565 blood measurements using a standard blood glucose monitoring system (BGMS) were collected from 1187 cases of patients with type 2 diabetes during hospitalization in the Department of Endocrinology, Guangdong General Hospital (Guangzhou, China). Stratified analyses were conducted by dividing the patients into 3 age groups, namely <45 years group (128 cases), 45-64 years group (594 cases), and ≥65 years group (465 cases). The incidence and time distribution of hypoglycemia in these patients were compared among the 3 age groups. The risk of hypoglycemia increased with age. Compared with those below 45 years of age, the patients beyond or equal to 65 years had a significantly increased hypoglycemic density (0.95% vs 0.40%, P<0.001), a higher proportion of patients with hypoglycemia (28.17% vs 10.94%, P<0.001), and greater patient-days with hypoglycemia (4.48% vs 1.76%, P<0.001). In the elderly patients, hypoglycemia occurred most frequently before dawn, at which time the hypoglycemic density was 2.66% in patients ≥65 years of age, significantly higher than that in patients below 45 years (1.09%, P<0.05) and between 45 and 64 years (1.90%, P<0.05); the proportion of patients with hypoglycemia was also significantly higher in the elderly patients (14.57%) than in those below 45 years (3.77%, P<0.02) and between 45 and 64 years (9.42%, P<0.02). The proportion of patients with recurrent hypoglycemia (≥2 times) was significantly higher in patients ≥65 years (13.33%) than in younger patients (2.34% in <45 years group and 9.43% in 45-64 years group, P<0.05). The hypoglycemic risk in hospitalized elderly patients with T2DM is significantly higher than that in younger patients, especially before dawn and in terms of recurrent hypoglycemia. Clinicians should develop differential blood glucose monitoring and management strategies for these elderly patients to improve the clinical safety.

Wearable Microsystem for Minimally Invasive, Pseudo-Continuous Blood Glucose Monitoring: The e-Mosquito

This paper presents a wearable microsystem for minimally invasive, autonomous, and pseudo-continuous blood glucose monitoring, addressing a growing demand for replacing tedious fingerpricking tests for diabetic patients. Unlike prevalent solutions which estimate blood glucose levels from interstitial fluids or tears, our design extracts a whole blood sample from a small lanced skin wound using a novel shape memory alloy (SMA)-based microactuator and directly measures the blood glucose level from the sample. In vitro characterization determined that the SMA microactuator produced penetration force of 225 gf, penetration depth of 3.55 mm, and consumed approximately 5.56 mW·h for triggering. The microactuation mechanism was also evaluated by extracting blood samples from the wrist of four human volunteers. A total of 19 out of 23 actuations successfully reached capillary vessels below the wrists producing blood droplets on the surface of the skin. The integrated potentiostat-based glucose sensing circuit of our e-Mosquito device also showed a good linear correlation (R2 = 0.9733) with measurements using standard blood glucose monitoring technology. These proof-of-concept studies demonstrate the feasibility of the e-Mosquito microsystem for autonomous intermittent blood glucose monitoring.

Psychosocial Correlates of Continuous Glucose Monitoring Use in Youth and Adults with Type 1 Diabetes and Parents of Youth

Continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce hypoglycemia with consistent use. Youth, however, are unlikely to use CGM consistently. We compared psychological characteristics of youth with type 1 diabetes, their parents, and adults with type 1 diabetes randomized to CGM or standard blood glucose monitoring (BGM). This study was an ancillary study, and participants completed the questionnaires at the 6-month visit of the main study. Participants enrolled at a single site of the Juvenile Diabetes Research Foundation CGM trial completed questionnaires and provided diabetes management data. Participants were randomized to the CGM or BGM group for 6 months. Parents in both groups reported more fear of hypoglycemia than youth in the corresponding groups. CGM youth and parents reported more negative affect around BGM than those in the BGM group. CGM youth reported more trait anxiety than BGM youth, whereas CGM adults reported less state and trait anxiety than BGM adults. CGM parent-proxy report of depression was significantly higher than that reported by BGM parents. Youth, their parents, and adults report different psychological impacts of CGM use. In some groups and with some variables, CGM use was associated with a positive psychosocial impact, whereas in others CGM use was associated with a negative psychosocial impact. Future research should explore the psychological consequences of CGM use.

Sensor-Augmented Insulin Pump Therapy: Results of the First Randomized Treat-to-Target Study

The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems. This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >or=7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated. A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P<0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P=0.0456). Fourteen severe hypoglycemic events occurred (11 in the SG group and three in the CG group, P=0.04). A1C reduction was no different between the two groups. Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use; however, there was no increase in hypoglycemia AUC or number of events in the SG group. Subjects with greater sensor utilization showed a greater improvement in A1C levels.