Automated insulin delivery for hospitalized patients with diabetes
Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial
PHASE3 · Emory University · NCT06418880
This study tests whether an automated insulin delivery system can help hospitalized patients with diabetes manage their blood sugar better than standard insulin shots.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 3 sites (Stanford, California and 2 other locations) |
| Trial ID | NCT06418880 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the efficacy and safety of automated insulin delivery (AID) compared to multiple daily insulin injections (MDI) plus continuous glucose monitoring (CGM) in hospitalized patients with type 1 or type 2 diabetes. Participants will be randomized to receive either AID with remote CGM or standard insulin therapy with CGM, and will be monitored for 10 days or until discharge. The study aims to improve glycemic control in inpatient settings, addressing the challenges of managing diabetes during hospitalization.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diabetes requiring inpatient insulin therapy and experiencing elevated glucose levels.
Not a fit: Patients who are admitted to the ICU or those with severe hyperglycemic crises or other significant medical instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance glycemic control and reduce complications for hospitalized patients with diabetes.
How similar studies have performed: Initial clinical trials using similar technologies have shown modest improvements in diabetes management, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 of 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 an outpatient * Patients who previously participated in AIDING feasibility trial or this RCT * Patients with a condition impeding the ability to consent or answer questionnaires * Patients who are pregnant or breastfeeding at the 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 * Adults unable to consent * Individuals \<18 years of age * Pregnant women * Prisoners * Cognitively impaired or Individuals with Impaired Decision-Making Capacity * Individuals who are not able to clearly understand English or Spanish will be excluded
Where this trial is running
Stanford, California and 2 other locations
- Stanford University School of Medicine — Stanford, California, United States (RECRUITING)
- Grady Health System (non-CRN) — Atlanta, Georgia, United States (RECRUITING)
- University of Virginia School of Medicine — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Francisco Pasquel, M.D., M.P.H — Emory University
- Study coordinator: Francisco Pasquel, M.D., M.P.H
- Email: fpasque@emory.edu
- Phone: 4047781695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Type 2 Diabetes, continuous glucose monitoring, automated insulin delivery, Insulin Therapy