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Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes.

ABSTRACT: To evaluate long-term effects of continuous glucose monitoring (CGM) in intensively treated adults with type 1 diabetes.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.In intensively treated adults with type 1 diabetes, CGM use and benefit can be sustained for 12 months.

SUBMITTER: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group

PROVIDER: S-EPMC2768224 | biostudies-literature | 2009 Nov

REPOSITORIES: biostudies-literature

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Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes.

Bode Bruce B Beck Roy W RW Xing Dongyuan D Gilliam Lisa L Hirsch Irl I Kollman Craig C Laffel Lori L Ruedy Katrina J KJ Tamborlane William V WV Weinzimer Stuart S Wolpert Howard H

Diabetes care 20090812 11

<h4>Objective</h4>To evaluate long-term effects of continuous glucose monitoring (CGM) in intensively treated adults with type 1 diabetes.<h4>Research design and methods</h4>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 subj ...[more]

PMID: 19675193

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Project description:ImportanceContinuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes.ObjectiveTo determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes.Design, setting, and participantsRandomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes.InterventionsParticipants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100).Main outcomes and measuresThe 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.ResultsOf 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).Conclusions and relevanceAmong 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.Trial registrationClinicalTrials.gov Identifier: NCT03240432.

Dataset Information

Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes.

Publications

Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes.

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