National Institute of Diabetes and Digestive Kidney Diseases* Share Plus: Continuous Glucose Moni… (NCT05937321) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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.
United States168 participantsStarted 2023-11-02
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.