Clinical trial NCT06418880: Automated Insulin Delivery for Inpatients With Dysglycemia
Official title: Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: continuous glucose monitoring
automated insulin delivery
Insulin Therapy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Annually, over 8 million people in the United States are hospitalized due to diabetes. Among these patients, those with uncontrolled diabetes are at a significantly heightened risk for poor hospital outcomes. However, achieving glycemic targets within hospital settings proves challenging, as doing so often increases the risk of iatrogenic hypoglycemia. This is exacerbated by the variable insulin therapy requirements that arise during acute illnesses, such as unpredictable nutrition intake, illness severity, and the effects of various medications. These fluctuations pose a substantial challenge for healthcare providers tasked with caring for patients with diabetes.

The usage of diabetes technology may offer an opportunity to improve inpatient diabetes care, but best practices are not yet defined. The COVID-19 pandemic has highlighted how accelerated use of technologies (e.g., telemedicine, e-consults, and remote monitoring) helps healthcare systems adapt care delivery while minimizing exposure risk. Following the non-objection by the US Food and Drug Administration (FDA) to the use of CGM in the hospital, the investigators and others implemented the usage of remote real-time CGM to treat patients with COVID-19. Initial clinical trials using remote real-time CGM have shown modest improvements in hypoglycemia detection and prevention and minimal or no increases in time spent in the target range (TIR) in non-ICU patients.

The use of AID with remote insulin delivery and remote glucose monitoring is novel for the inpatient setting. The use of AID allows for 288 automated insulin dosing alterations per day, which is infeasible for hospital staff and could help proactively compensate for the multitude of factors affecting insulin requirements in the hospital. Preliminary data from AID trials with a single European AID system (using an insulin pump with tubing) have shown improvements in glycemic control in diverse populations without increasing the risk of hypoglycemia. However, these trials have limited involvement of patient care teams and the feasibility of hospital implementation and adoption is unknown.

Using single-use insulin patch-pumps (without tubing) may offer a unique opportunity for hospital use of AID; however, no randomized controlled data on the use of AID in the hospital is available in the US. Results from our recently completed pilot study show that using AID with remote CGM is feasible in the hospital and appears to be associated with good glycemic control.

In addition to improving glycemic control, this approach will:

* Offer a unique treatment option for patients typically excluded from inpatient clinical trials, including patients with type 1 diabetes, steroids, medical nutrition therapy, or those under isolation precautions.
* Use superficial wearable medical devices to alleviate inconveniences and discomforts to patients associated with current standard-of-care insulin therapy. The combination of a CGM and a patch-based insulin pump can greatly reduce the need for recurrent "sticks" and "pricks." They may thereby improve the quality of experience for patients admitted to the hospital.
* Introduce remote insulin delivery and remote glucose monitoring, offering an unprecedented opportunity for effective diabetes care for people with highly contagious diseases or while interacting with patients during emergency conditions.
* Set the stage for subsequent inpatient diabetes technology implementation efforts. The investigator's approach has multiple layers of safety to ensure improved glycemic control without increasing the risk of hypoglycemia, including a) nursing staff training for rapid response, b) EHR documentation and validation of sensor glucose values to confirm accuracy, c) remote monitoring with alarms (telemetry and inpatient treatment team).

Eligibility 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

Primary outcomes:
measure: Efficacy: Time spent in glucose target range
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Safety: Time spent below the target glucose range
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
Secondary outcomes:
measure: TAR >250mg/dl
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: TBR <70 mg/dl
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Mean hospitalization glucose
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
Other outcomes:
measure: Time spent above 180 mg/dl
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Time spent between 70-99 mg/dl
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Glycemic events above 300 mg/dl
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Glycemic events below 54 mg/dl
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of hypoglycemic episodes (Glucose <40 mg/dl)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of Diabetes-related Ketoacidosis Events
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of hyperosmolar hyperglycemic syndrome (HHS) events
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Atlanta
country: United States
facility: Grady Health System (non-CRN)
state: Georgia
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: Emory University
name: Francisco Pasquel, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References: