Differences for Percentage Times in Glycemic Range Between Continuous Glucose Monitoring and Capillary Blood Glucose Monitoring in Adults with Type 1 Diabetes: Analysis of the REPLACE-BG Dataset

Objective: To compare healthcare utilization, costs, and incidence of diabetes-specific adverse events (ie, hyperglycemia, diabetic ketoacidosis, and hypoglycemia) in type 1 diabetes adult patients using real-time continuous glucose monitoring (rtCGM) versus traditional blood glucose monitoring (BG). Methods: Adult patients (≥18 years old) with type 1 diabetes in a large national administrative claims database between 2013 and 2015 were identified. rtCGM patients with 6-month continuous health plan enrollment and ≥1 pharmacy claim for insulin during pre-index and post-index periods were propensity-score matched with BG patients. Healthcare utilization associated with diabetic adverse events were examined. A difference-in-difference (DID) method was used to compare the change in costs between rtCGM and BG cohorts. Results: Six-month medical costs for rtCGM patients ( N = 153) increased from pre- to post-index period, while they decreased for matched BG patients ( N = 153). DID analysis indicated a $2,807 ( P = .062) higher post-index difference in total medical costs for rtCGM patients. Pharmacy costs for both cohorts increased. DID analysis indicated a $1,775 ( P < .001) higher post-index difference in pharmacy costs for rtCGM patients. The incidence of hyperglycemia for both cohorts increased minimally from pre- to post-index period. The incidence of hypoglycemia for rtCGM patients decreased, while it increased marginally for BG patients. Inpatient hospitalizations for rtCGM and BG patients increased and decreased marginally, respectively. Conclusions: rtCGM users had non-significantly higher pre-post differences in medical costs but significantly higher pre-post differences in pharmacy costs (mostly due to the rtCGM costs themselves) compared to BG users. Changes in adverse events were minimal.

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A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Finger-stick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes

10.2337/figshare.13148741 ◽

2020 ◽

Author(s):

Linda A. DiMeglio ◽

Lauren G. Kanapka ◽

Daniel J. DeSalvo ◽

Marisa E. Hilliard ◽

Lori M. Laffel ◽

...

Keyword(s):

Type 1 Diabetes ◽

Blood Glucose ◽

Young Children ◽

Behavioral Intervention ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Well Being ◽

Blood Glucose Monitoring

Objective: This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to <8 years with type 1 diabetes Research Design and Methods: A multicenter (N=14), 6-month, randomized controlled trial including 143 youth 2 to <8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR, 70-180 mg/dL) across follow-up visits. Results: About 90% of participants in the CGM groups used CGM ≥ 6 days/week at 6-months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs BGM = 3.2% [95% CI -0.5%, 7.0%], Standard-CGM vs BGM = 0.5% [-2.6% to 3.6%], CGM+FBI vs Standard-CGM = 2.7% [-0.6%, 6.1%]. Mean time <70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups , compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM, p<0.001, Standard-CGM vs BGM p<0.001). No severe hypoglycemic events occurred in the CGM+FBI group, 1 in the Standard-CGM, and 5 in the BGM. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (p=0.008 and 0.04) and BGM (p=0.02 and 0.002). Conclusions: CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.

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REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes

Diabetes Care ◽

10.2337/dc16-2482 ◽

2017 ◽

Vol 40 (4) ◽

pp. 538-545 ◽

Cited By ~ 101

Author(s):

Grazia Aleppo ◽

Katrina J. Ruedy ◽

Tonya D. Riddlesworth ◽

Davida F. Kruger ◽

Anne L. Peters ◽

...

Keyword(s):

Type 1 Diabetes ◽

Blood Glucose ◽

Randomized Trial ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Routine Blood

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A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Finger-stick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes

10.2337/figshare.13148741.v1 ◽

2020 ◽

Author(s):

Linda A. DiMeglio ◽

Lauren G. Kanapka ◽

Daniel J. DeSalvo ◽

Marisa E. Hilliard ◽

Lori M. Laffel ◽

...

Keyword(s):

Type 1 Diabetes ◽

Blood Glucose ◽

Young Children ◽

Behavioral Intervention ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Well Being ◽

Blood Glucose Monitoring

Objective: This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to <8 years with type 1 diabetes Research Design and Methods: A multicenter (N=14), 6-month, randomized controlled trial including 143 youth 2 to <8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR, 70-180 mg/dL) across follow-up visits. Results: About 90% of participants in the CGM groups used CGM ≥ 6 days/week at 6-months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs BGM = 3.2% [95% CI -0.5%, 7.0%], Standard-CGM vs BGM = 0.5% [-2.6% to 3.6%], CGM+FBI vs Standard-CGM = 2.7% [-0.6%, 6.1%]. Mean time <70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups , compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM, p<0.001, Standard-CGM vs BGM p<0.001). No severe hypoglycemic events occurred in the CGM+FBI group, 1 in the Standard-CGM, and 5 in the BGM. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (p=0.008 and 0.04) and BGM (p=0.02 and 0.002). Conclusions: CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.

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Good Metabolic Control in Children with Type 1 Diabetes Mellitus: Does Glycated Hemoglobin Correlate with Interstitial Glucose Monitoring Using FreeStyle Libre?

Journal of Clinical Medicine ◽

10.3390/jcm10214913 ◽

2021 ◽

Vol 10 (21) ◽

pp. 4913

Author(s):

Rocio Porcel-Chacón ◽

Cristina Antúnez-Fernández ◽

Maria Mora Loro ◽

Ana-Belen Ariza-Jimenez ◽

Leopoldo Tapia Ceballos ◽

...

Keyword(s):

Type 1 Diabetes ◽

Blood Glucose ◽

Metabolic Control ◽

Glycated Hemoglobin ◽

Glucose Monitoring ◽

Capillary Blood ◽

Capillary Blood Glucose ◽

Good Metabolic Control ◽

One Year

Background: Good metabolic control of Type 1 diabetes (T1D) leads to a reduction in complications. The only validated parameter for establishing the degree of control is glycated hemoglobin (HbA1c). We examined the relationship between HbA1c and a continuous glucose monitoring (CGM) system. Materials and methods: A cohort prospective study with 191 pediatric patients with T1D was conducted. Time in range (TIR), time below range (TBR), coefficient of variation (CV), number of capillary blood glucose tests, and HbA1c before sensor insertion and at one year of use were collected. Results: Patients were classified into five groups according to HbA1c at one year of using CGM. They performed fewer capillary blood glucose test at one year using CGM (−6 +/− 2, p < 0.0001). We found statistically significant differences in TIR between categories. Although groups with HbA1c < 6.5% and HbA1c 6.5–7% had the highest TIR (62.214 and 50.462%), their values were highly below optimal control according to CGM consensus. Groups with TBR < 5% were those with HbA1c between 6.5% and 8%. Conclusions: In our study, groups classified as well-controlled by guidelines were not consistent with good control according to the CGM consensus criteria. HbA1c should not be considered as the only parameter for metabolic control. CGM parameters allow individualized targets.

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