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NIDDK Share Plus: Continuous Glucose Monitoring With Data Sharing in Older Adults With T1D and Their Care Partners


Description

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.Older adults with type 1 diabetes (T1D) have an increased risk of hypoglycemia and hyperglycemia that can result in grave health consequences, such as seizures, falls, and myocardial infarctions. Care partners (e.g., spouses, friends) regularly become part of the diabetes care team to assist in self-management as a person with diabetes ages. A technological advancem

Trial Eligibility

Inclusion Criteria for PWD: * 60 + years of age * Type 1 Diabetes Diagnosis * HbA1c greater than or equal to 7.5% and less than or equal to 11% * 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 * Naive to using Follow app and willing to use the Follow app 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

Study Info

Organization

University of Utah


Primary Outcome

Time in Range


Outcome Timeframe Change from 12 weeks to 24 weeks

NCTID NCT05937321

Phases NA

Primary Purpose TREATMENT

Start Date 2023-11-02

Completion Date 2025-08-31

Enrollment Target 160

Interventions

BEHAVIORAL Share plus intervention

BEHAVIORAL Control group

Locations Recruiting

University of Utah College of Nursing

United States, Utah, Salt Lake City


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