Dataset Information

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes.

ABSTRACT: Objective: To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. Research Design and Methods: WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. Results: CGM was used a median of >90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time <70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks (P < 0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% vs. 64%; P < 0.001) and had lower hemoglobin A1c (HbA1c) (mean 7.6% [59 mmol/mol] vs. 7.4% [57 mmol/mol]; P = 0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time <70 mg/dL decreased from 3.9% to 1.9% (P < 0.001), TIR increased from 56% to 60% (P = 0.006) and HbA1c decreased from 7.5% (58 mmol/mol) to 7.3% (57 mmol/mol) (P = 0.025). In BGM-CGM, a severe hypoglycemic event was reported for nine participants while using BGM during the RCT and for two participants during the extension phase with CGM (P = 0.02). Conclusions: CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice. Clinicaltrials.gov (NCT03240432).

SUBMITTER: Miller KM

PROVIDER: S-EPMC9208859 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes.

Miller Kellee M KM Kanapka Lauren G LG Rickels Michael R MR Ahmann Andrew J AJ Aleppo Grazia G Ang Lynn L Bhargava Anuj A Bode Bruce W BW Carlson Anders A Chaytor Naomi S NS Gannon Gail G Goland Robin R Hirsch Irl B IB Kiblinger Lisa L Kruger Davida D Kudva Yogish C YC Levy Carol J CJ McGill Janet B JB O'Malley Grenye G Peters Anne L AL Philipson Louis H LH Philis-Tsimikas Athena A Pop-Busui Rodica R Salam Maamoun M Shah Viral N VN Thompson Michael J MJ Vendrame Francesco F Verdejo Alandra A Weinstock Ruth S RS Young Laura L Pratley Richard R

Diabetes technology & therapeutics 20220411 6

Objective: To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. Research Design and Methods: WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants conti ...[more]

PMID: 35294272

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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.

Project description:ObjectiveTight glycemic control can potentially reduce morbidity and mortality in the intensive care unit but increases the risk of hypoglycemia. The most effective means to avoid hypoglycemia is to obtain frequent blood glucose samples, but this increases the burden to nursing staff. The objective of this study was to assess the ability of a real-time continuous glucose monitor to reduce hypoglycemia (blood glucose <60 mg/dL [3.3 mmol/L]) during standard care or tight glycemic control effected with a proportional integral derivative insulin titration algorithm.DesignReal-time continuous glucose monitor profiles obtained from an ongoing prospective randomized trial of tight glycemic control were retrospectively analyzed to determine whether the continuous glucose measure had prevented instances of hypoglycemia.SettingCardiac intensive care unit.PatientsChildren 3 yrs of age or younger undergoing cardiac surgery were studied.InterventionsIntravenous insulin infusion and rescue glucose guided by the real-time continuous glucose monitor and the proportional integral derivative algorithm in the tight glycemic control arm (n = 155; target glucose 80-110 mg/dL [4.4-6.1 mmol/L]) and the real-time continuous glucose monitor in the standard care arm (n = 156).Measurements and main resultsNo reduction in hypoglycemia was observed with real-time continuous glucose monitor alarms set at 60 mg/dL (3.3 mmol/L) (zero of 19 occurrences of blood glucose <60 mg/dL [3.3 mmol/L] detected); 18 of 40 subsequent incidences of hypoglycemia were detected after the alarm threshold was increased to 70 mg/dL (3.9 mmol/L). In the tight glycemic control arm, eight incidences were reduced in duration and an additional eight events were prevented with intravenous glucose. In the standard care arm, three of nine occurrences of hypoglycemia were detected with the duration reduced in all cases. On average, one to two false hypoglycemia alarms were observed in each patient.ConclusionsThe real-time continuous glucose monitor in combination with proportional integral derivative control can reduce hypoglycemia during tight glycemic control. The real-time continuous glucose monitor can also reduce hypoglycemia during standard care. However, false alarms increase the overall nursing workload.

Dataset Information

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes.

Publications

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes.

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