Automated Insulin Delivery for Inpatients With Dysglycemia (NCT06418880) | Clinical Trial Compass
CompletedPhase 3
Automated Insulin Delivery for Inpatients With Dysglycemia
United States130 participantsStarted 2025-01-22
Plain-language summary
This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors.
The main objectives of this study are:
* To test the efficacy and safety of AID versus multiple daily insulin injections (MDI) + CGM in the inpatient setting
* To determine differences in CGM-derived metrics between AID and MDI plus CGM in the hospital and explore differences in treatment effect according to individual characteristics.
Participants will be:
* Randomized to AID + remote CGM (intervention) or multiple daily insulin injections (MDI) + CGM (control group)
* Followed for a total of 10 days or until hospital discharge (if less than 10 days).
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:
• Any person ≥18 years of age with diabetes mellitus (except cystic fibrosis- and pregnancy-related) admitted to general (non-ICU) medical-surgical hospital services which require inpatient insulin therapy (i.e.,TID or T2D with ≥2 glucose values ≥180mg/dl)
Exclusion Criteria:
* Patients admitted to ICU
* Patients anticipated to require less than 48 hours admission.
* Current evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state)
* Severe anemia with hemoglobin \<7 g/dL
* Evidence of hemodynamic instability
* Hypoxia (SpO2 \<92% on supplemental oxygen)
* Pre-admission or inpatient total-daily insulin dose \>150 units daily
* T2D patients on sliding scale insulin therapy alone (no scheduled basal or bolus insulin) and with glucose levels below 180 mg/dl
* Patients without diabetes with stress hyperglycemia (not related to steroids or medical nutrition therapy) and with HbA1c \<6.5%
* Patients on AID as outpatient
* Patients who previously participated in AIDING feasibility trial or this RCT
* Patients with a condition impeding their ability to consent or answer questionnaires or notify staff of symptoms.
* Patients who are pregnant time of enrollment
* Patients who are unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, or Novolog) during the study
* Use of hydroxyurea, high dose of acetaminophen (\>4 grams/day), or high dose ascorbic acid
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
Efficacy: Time spent in glucose target range
Timeframe: Up to 10 days (or hospital discharge if before 10 days)
2
Safety: Time spent below the target glucose range
Timeframe: Up to 10 days (or hospital discharge if before 10 days)