N/A
Completed N=22
Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
Source: ClinicalTrials.gov NCT04714216 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria — 91 percentage of time
Summary
This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria |
91 | — |
| PRIMARY Percentage of Time Sensor Glucose is Within Target Glucose Range |
68 | — |
| SECONDARY Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation) |
— | — |
| SECONDARY Percentage of Time With CGM Readings |
99 | — |
| SECONDARY Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing |
85 | — |
| SECONDARY Percentage of CGM Readings Within %15/15 of POC Readings and Within %20/20 of POC Readings With the Cut Point at 70 mg/dL |
71; 81 | — |
| SECONDARY Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient |
— | — |
| SECONDARY Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day |
— | — |
| SECONDARY Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient |
— | — |
| SECONDARY Percent Time Below Range (TBR) of <70mg/dL |
0.17 | — |
| SECONDARY Percent Time Below Range (TBR) of <54 mg/dL |
0.06 | — |
| SECONDARY Percent Time Above Range (TAR) of >180 mg/dL |
25 | — |
| SECONDARY Percent Time in Severe Hyperglycemia (>250 mg/dL) |
6.9 | — |
| SECONDARY Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) |
3 | — |
| SECONDARY Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate |
— | — |
| SECONDARY Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR) |
3 | — |
| SECONDARY Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF) |
— | — |
| SECONDARY Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) |
6 | — |
| SECONDARY Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate |
6 | — |
| SECONDARY Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR |
25 | — |
| SECONDARY Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF |
14 | — |
| SECONDARY Total Daily Insulin (TDI) |
0.41 | — |
| SECONDARY Total Daily Basal Insulin (TBI) |
0.21 | — |
| SECONDARY Total Daily Bolus Meal/Correction |
0.23 | — |
| SECONDARY Number of Hypoglycemic Events That Required Assistance of Another Person |
— | — |
| SECONDARY Number of Diabetic Ketoacidosis Events |
— | — |
| SECONDARY Patient Acceptability of HCL System |
8; 8; 0; 0; 0 | — |
| SECONDARY Patient Perceptions of HCL System Use |
15; 1; 0; 16; 6; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥18 years of age with insulin-treated T1 or Type 2 diabetes mellitus (T2DM) admitted to general (non-intensive care) medical-surgical hospital service requiring inpatient insulin therapy.
Exclusion Criteria
- Patients admitted the ICU or anticipated to require ICU transfer
- Anticipated length of hospital stay 100 units
- Mental condition rendering the participant unable to consent or answer questionnaires
- Pregnant or breast feeding at time of enrollment
- Unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, Novolog or Apidra) during the study
- Use of hydroxyurea or high-dose ascorbic acid (>1g/day)
- Coronavirus Disease 2019 (COVID-19) infection or person under investigation (PUI) on isolation precautions
Data sourced from ClinicalTrials.gov (NCT04714216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.