Technological Advances in Glucose Management in Older Adults (NCT03078491) | Clinical Trial Compass
CompletedNot Applicable
Technological Advances in Glucose Management in Older Adults
United States168 participantsStarted 2017-03-30
Plain-language summary
This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. The DMP includes an automated data transfer from CGM, insulin-delivery devices, and activity tracker to a clinical decision support system (CDS) that provides dosing adjustment recommendations based on that data to the healthcare team. In addition, the DMP includes on-demand education for patients and caregivers, and an interface for communication between providers, patients, and their caregivers.
Who can participate
Age range
65 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:
* Patients with age ≥ 65 years
* Community-living
* Clinical diagnosis of T1D
* On multiple insulin injections (≥3 injection/s day) or insulin pump.
Exclusion Criteria:
* Use of real-time CGM in past 2 years
* A1c \> 10% (since individuals with very poor glycemic control usually have barriers to optimal self-care that preclude effective use of technology)
* Use of insulin pump that cannot be uploaded for CDS
* Unable or unwilling to perform task needed for study participation during the run-in period
* Severe vision or hearing impairment that could interfere with study tasks
* Need to use acetaminophen on regular basis (since can interfere with CGM accuracy)
* Living in an institutional setting (e.g. group homes, nursing homes)
* Terminal diseases with life expectancy \< 1 year (e.g. malignancy)
* Severe comorbidities that prevent completing outcome measurements (e.g. severe dementia, severe vision impairment, severe functional disabilities, inability to perform basic activities of daily living)
* Alcohol or other drug abuse
* Conditions that impact wear of CGM (e.g. CHF with edema, skin conditions); and
* End stage renal insufficiency (eGFR\<30), or on dialysis (since impact of fluid shift on sensor lag not clearly understood).
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.
What they're measuring
1
Change in duration of hypoglycemia
Timeframe: change of duration of hypoglycemia(minutes/day) from baseline to 6 months between intervention and control groups