Continuous Glucose Monitoring Using a New Subcutaneous Insulin Protocol for Mild to Moderate Diab… (NCT06693115) | Clinical Trial Compass
WithdrawnNot Applicable
Continuous Glucose Monitoring Using a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis
Stopped: The trial was deemed to be unfeasible to commence at this site.
United States0Started 2026-01
Plain-language summary
Using a prospective, mixed methods study design, the investigators will assess the feasibility, usefulness, and care team acceptability of CGM in conjunction with FSBG during implementation of the new subQ DKA/HHS protocol at Regions Hospital. This will include evaluating how many patients agree to have a CGM device placed, time to place the CGM devices, CGM impact on length of stay, level of care required, frequency of alerts to changing glucose levels events, and assessing the match between CGM and FSBG readings done in the inpatient setting. Results will help inform cost effective, safe, patient-centered strategies, while gauging care team satisfaction to optimize DKA and HHS management in the future.
Who can participate
Age range
18 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:
* 18 years or older
* Presents at Regions Hospital ED including transfers from other hospitals
* Meets criteria for new subQ insulin protocol:
* Diagnosis of DKA or HHS (hyperosmolar hyperglycemic state) and provider decision to initiate insulin
* pH ≥ 7.1
* HCO3 ≥ 12
Exclusion Criteria:
* Under 18 years of age
* Excluded from new subQ protocol, specifically:
* Acute CHF exacerbation
* Acute MI (ACS/NSTEMI type 1 not demand ischemia)
* CKD stage 4 or AKI with creatinine \> 3
* ESLD
* Pregnancy
* Severe sepsis or septic shock
* AMS \> if patient cannot consent
* Euglycemic DKA
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
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
Timeframe: Duration of hospital stay from admission to discharge (average of 4 days).
2
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
Timeframe: From time of admission until the time of first insulin administration by CGM (average of 2 hours).