The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve quality of life in older adults with T1D.
Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve quality of life including reducing hypoglycemic fear and diabetes distress. Despite these potential benefits, CGM is used by only a small proportion of older adults with T1D. Previous studies assessing CGM efficacy have included only a small number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia, focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors. These studies are not generalizable to the population of older adults with T1D. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. The goal of this study is to assess the potential benefits and risks of CGM in older adults with T1D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.
University of Southern California
Beverly Hills, California, United States
Time spent with glucose level <70 mg/dL
The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (\<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.
Time frame: 6 months (26 weeks) from baseline
Change in HbA1c
Mean ± SD values for the change in HbA1c from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be computed for each randomization group and compared in a regression model adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Preferring Hypoglycemia Scale
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
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Scripps Whittier Diabetes Institute
La Jolla, California, United States
University of Colorado - Barbara Davis Center
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Florida Hospital Diabetes Institute
Orlando, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
University of Massachusetts
Worcester, Massachusetts, United States
...and 12 more locations
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Hypoglycemia Fear Survey
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Diabetes Distress Questionnaire
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Change in QOL: PROMIS Measures for QOL
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Change in QOL: NIH Cognitive Toolbox
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Change in QOL: NIH Emotions Toolbox
Mean ± SD values for the change in total and composite score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Time frame: 6 months (26 weeks) from baseline
Time spent with glucose level <60 mg/dL
Analyses will be similar to the primary objective.
Time frame: 6 months (26 weeks) from baseline
Time spent with glucose level <54 mg/dL
Analyses will be similar to the primary objective.
Time frame: 6 months (26 weeks) from baseline