Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418880
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-13
Brief Title:
Automated Insulin Delivery for Inpatients With Dysglycemia
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Automated Insulin Delivery for Inpatients With Dysglycemia AIDING Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIDING
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 medicalsurgical 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
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 eg 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 investigators 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
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 eg 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 investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK138366-01 | NIH | None | httpsreporternihgovquickSearch1R01DK138366-01 |