Continuous glucose monitor (CGM), blinded for Stress Hyperglycemia

Grady Hospital, Atlanta, GA
Stress HyperglycemiaContinuous glucose monitor (CGM), blinded - Device
Eligibility
45 - 80
All Sexes
What conditions do you have?
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Study Summary

This trial will help determine if dulaglutide can prevent high blood sugar levels in people without diabetes who are having surgery.

Eligible Conditions
  • Stress Hyperglycemia

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

1
Continuous Glucose Monitor Application
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2
DTX401

Study Objectives

4 Primary · 50 Secondary · Reporting Duration: Up to 3 months after discharge

Baseline
Baseline Insulin Secretion
Baseline Insulin Sensitivity
Baseline insulin secretion between patients with and without stress hyperglycemia (SH)
Baseline insulin sensitivity between patients with and without stress hyperglycemia (SH)
Hour 72
Change in Adiponectin Level
Change in High Sensitivity C-reactive Protein (hsCRP) Level
Change in Level of Free Fatty Acids (FFA)
Change in Level of Thiobarbituric Acid Reactive Substances (TBARS)
Change in Plasma Cortisol Level
Change in Tumor Necrosis Factor-alpha (TNF-α) Level
Day 14
Baseline and Postoperative inflammatory biomarker level
Baseline and Postoperative oxidative stress biomarker level
Incidence of any perioperative complications
Incidence of stress hyperglycemia (SH)
Length of Hospital Stay
Length of hospital stay in patients with and without stress hyperglycemia (SH)
Maximum Daily Glucose Values
Maximum Daily Glucose Values (Aim 2)
Maximum daily glucose values measured by CGM (continues glucose monitoring)
Maximum daily glucose values measured by POC (point of care testing)
Mean Daily Glucose Values
Mean Daily Glucose Values (Aim 2)
Mean Duration of Stress Hyperglycemia (Glucose >140 mg/dL)
Mean Duration of Stress Hyperglycemia During the Postoperative Period
Mean Onset of Stress Hyperglycemia (Glucose >140 mg/dL)
Mean Onset of Stress Hyperglycemia During the Postoperative Period
Mean daily glucose values measured by CGM (continues glucose monitoring)
Mean daily glucose values measured by POC (point of care)
Mean duration of stress hyperglycemia (SH)during the postoperative period by CGM data
Mean onset time of stress hyperglycemia (SH) during the postoperative period by CGM data.
Number of ICU Transfers
Hyperglycemia
Number of Participants Experiencing Complications
Percentage of Time in Hyperglycemia (Glucose>140 mg/dL)
Percentage of Time in Hyperglycemia (Glucose>180 mg/dL)
Percentage of Time in Hypoglycemia (Glucose <40 mg/dL)
Percentage of Time in Hypoglycemia (Glucose <54 mg/dL)
Percentage of Time in Hypoglycemia (Glucose <70 mg/dL)
Percentage of time in hyperglycemia (>140 mg/dL)
Percentage of time in hyperglycemia (>180 mg/dL)
Glucose
Percentage of time in hypoglycemia (glucose <54 mg/dL)
Percentage of time in hypoglycemia (glucose <70 mg/dL)
Percentage of time in target glucose range (70-140 mg/dL) by CGM
Percentage of time with glucose >140 mg/dL
Perioperative Insulin Requirements
Perioperative insulin requirements (total daily insulin dose).
Total Daily Insulin Dose
Total daily insulin dose in patients with and without stress hyperglycemia (SH)
Total number of following complications: wound infection, respiratory failure, pneumonia, acute kidney injury (increase in creatinine by 0.5 mg/dL), and major adverse cardiac events (MACE).
Month 3
Number of Emergency Room Visits After Discharge
Number of Hospital Readmissions After Discharge
Number of emergency room visits after discharge in patients with and without stress hyperglycemia (SH)
Number of hospital readmissions after discharge in patients with and without stress hyperglycemia (SH)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Continuous Glucose Monitor Application
1
Continuous Glucose Monitor (CGM)
3
DTX401

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3 Treatment Groups

Continuous Glucose Monitoring
1 of 3
Dulaglutide
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

245 Total Participants · 3 Treatment Groups

Primary Treatment: Continuous glucose monitor (CGM), blinded · Has Placebo Group · Phase 4

Continuous Glucose Monitoring
Device
Experimental Group · 1 Intervention: Continuous glucose monitor (CGM), blinded · Intervention Types: Device
DulaglutideExperimental Group · 2 Interventions: Continuous glucose monitor (CGM), blinded, Dulaglutide · Intervention Types: Device, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Continuous glucose monitor (CGM), blinded, Placebo · Intervention Types: Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months after discharge

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,496 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,550 Previous Clinical Trials
24,610,900 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,212 Previous Clinical Trials
4,193,438 Total Patients Enrolled
Georgia Davis, MDPrincipal Investigator - Emory University
Northeast Georgia Medical Center - Gainesville
Emory University School Of Medicine (Medical School)
Emory University School Of Medicine (Residency)

Eligibility Criteria

Age 45 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) of 30 or higher, and no known history of diabetes.
You have a body mass index (BMI) of 30 or higher and either have pre-diabetes or diabetes based on blood sugar tests.
You are a man or woman aged 45 to 80 years old having general or vascular surgery that is not related to the heart.
You are between 45 and 80 years old and do not have a history of diabetes. You are having surgery that is not related to the heart or blood vessels. This is for Aim 1 of the study.
References

Frequently Asked Questions

What is the upper cap of participants involved in this experiment?

"Affirmative. The information available at clinicaltrials.gov specifies that this medical experiment is actively enrolling individuals, which was first announced on July 29th 2021 and was last updated the same day. It seeks to recruit 245 members from two separate sites." - Anonymous Online Contributor

Unverified Answer

Who is qualified to partake in this medical experiment?

"This clinical trial requires 245 individuals aged 45 to 80 with hyperglycemia. Of particular note, the required criteria are: BMI ≥30 kg/m2 and no prior diagnosis of diabetes mellitus (DM), male or female participants between 45-80 years undergoing non-cardiac general or vascular surgery in Aim 1., and an additional requirement of either pre-diabetes by OGTT or HbA1c for those without known history of DM also participating in Aim 1." - Anonymous Online Contributor

Unverified Answer

What are the primary aims of this investigation?

"The primary aim of this trial, which is expected to be completed within two weeks (depending on hospital stay duration), is to measure the prevalence of stress hyperglycemia. Secondary indicators that will also be observed include number and percentage of transfers from ICU in SH patients, frequency of hypoglycaemia events under a glucose level below 40 mg/dL, as well as length of hospitalisation for those with or without SH." - Anonymous Online Contributor

Unverified Answer

Has the Continuous Glucose Monitor been granted blind approval by the FDA?

"Our team at Power has determined that the safety of Continuous Glucose Monitor (CGM) technology, when used in a blinded fashion, is highly reliable based on its Phase 4 status; this treatment option is already approved." - Anonymous Online Contributor

Unverified Answer

What medical reason is the Continuous Glucose Monitor (CGM) typically utilized for?

"The use of a Continuous glucose monitor (CGM) has been demonstrated to effectively manage type 2 diabetes mellitus, reduce cardiovascular risk factors, and adjust dietary habits." - Anonymous Online Contributor

Unverified Answer

Are there any available slots remaining in this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that this investigation, which was inaugurated on July 29th 2021, is actively seeking out patients to join their team of 245 individuals from 2 different medical sites." - Anonymous Online Contributor

Unverified Answer

Is there a minimum age requirement for participation in the research study?

"This clinical trial requests applicants between the ages of 45 and 80. For those outside this age range, 4 separate studies are available for under 18s and over 65s respectively." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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