National Institute of Diabetes and Digestive Kidney Diseases* Share Plus: Continuous Glucose Monitoring with Data Sharing in Older Adults with Type 1 Diabetes* and Their Care Partners to Improve Time in Range and Reduce Diabetes Distress.
NCT05937321
Summary
The purpose of this study is to test the Share plus intervention aimed at improving the use of data sharing between people with diabetes and their care partners in order to maximize the benefits of continuous glucose monitoring. Hypothesis: Compared to the control group, persons with diabetes enrolled in the Share plus intervention group will experience clinically significant improvements in time-in-range (TIR) (\>5%) at 12- and 24-weeks into the study, and improvement on diabetes distress. Care partners enrolled in the Share plus intervention group will experience lower diabetes distress at 12- and 24-weeks into the study.
Eligibility
Inclusion Criteria for PWD: * 60 + years of age * Type 1 Diabetes Diagnosis * HbA1c no greater than 11.0% * Currently using continuous glucose monitoring * Able to manage diabetes with respect to insulin administration and glucose monitoring (which may include assistance from a care partner Inclusion Criteria for CP: * ≥18 years of age * Participant understands the study protocol and agrees to comply with it Exclusion Criteria for PWD: * Life expectancy estimated at \< 1 year * Extreme visual or hearing impairment that would hinder the ability to use CGM * Stage 4 or 5 renal disease or most recent Glomerular filtration rate (GFR) \<30 ml/min/m2 from a local lab within the past six months * The presence of a significant medical or psychiatric condition or use of a medication that in the investigator's judgment may affect the completion of any aspect of the protocol. * Clinical diagnosis of moderate or severe dementia * Inpatient psychiatric treatment in the past six months * Participation in an intervention study in the past six weeks * Montreal Cognitive Assessment Score \< 19 Exclusion criteria for CP: * Cognitive impairment or dementia * Medical condition that will make it inappropriate or unsafe to fulfill the role of a CP
Conditions2
Locations1 site
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NCT05937321