Time in Glucose Hospital Target

NCT05135676 | Completed DMC FDA Device

• 1 other identifier: TIGHT
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 6

Brief Summary

Inpatient management of glycemia in people with diabetes has been inadequately studied. Previous randomized trials of intensive insulin therapy in the hospital setting resulted in excessive hypoglycemia. Current ADA guidelines (glucose 140-180 mg/dL) are by consensus with the upper bound defined by observational data and the lower bound by safety concerns. None of the previous studies of intensive glucose management used CGM technology. Whether near normal glucose levels can be achieved without increasing hypoglycemia among hospitalized patients with diabetes with the advent of CGM technology is not known. There are clear associations between hyperglycemia and poor outcomes in patients with diabetes hospitalized with infection, including COVID-19. The COVID-19 pandemic has increased the urgency to definitively answer the question of whether glucose lowering below 140-180 mg/dL can be achieved without increasing hypoglycemia. If this proposed study demonstrates intensive management of glucose to a target of 90 to 130 mg/dL without hypoglycemia is achievable in the inpatient setting with CGM technology, a larger study could then be performed to evaluate whether there is clinical benefit including a reduction in morbidity and mortality. The primary study hypothesis is that glucose management with CGM can achieve a mean glucose of 90-130 mg/dL without increasing hypoglycemia compared with standard care with a glucose target of 140-180 mg/dL. Individuals with diabetes who are hospitalized (non-ICU) for an eligible condition will be randomly assigned to receive standard therapy (glucose target 140-180 mg/dL per ADA guidelines) or intensive therapy (glucose target 90-130 mg/dL and CGM used for monitoring). Real-time CGM will be used in the Intensive Target Group and masked CGM will be used in the Standard Target Group. The co-primary outcomes, assessed via a hierarchical approach, include a treatment group comparison of mean glucose (superiority) followed by a non-inferiority comparison of time \<54 mg/dL measured with CGM.

Conditions

Diabetes Mellitus, Type 2

Keywords

Continuous glucose monitoring; Hypoglycemia; Glycemia; Hyperglycemia; In-patient; Hospital

Outcome Measures

Primary Outcomes (2)

• Co-primary Outcome: CGM-measured mean glucose (superiority)

  In this trial, one of the co-primary outcomes measured using CGM for up to 10 days following randomization is the mean glucose which is tested for superiority between the intensive treatment and standard treatment.

  4-10 days

• Co-primary Outcome: CGM-measured percent time <54 mg/dL (non-inferiority)

  In this trial, the other co-primary outcome measured using CGM for up to 10 days following randomization is the percent time below 54 mg/dL which is tested to demonstrate non-inferiority of intensive treatment compared with standard treatment.

  4-10 days

Secondary Outcomes (2)

• CGM Metrics by daytime only (06:00 AM to 00:00 AM)

  4-10 days

• CGM Metrics by nighttime only (00:00 AM to 06:00 AM)

  4-10 days

Other Outcomes (5)

• CGM metrics related to hypoglycemia

  4-10 days

• CGM metrics related to hypoglycemia

  4-10 days

• CGM metrics related to hyperglycemia

  4-10 days

Study Arms (2)

Standard Target Group

ACTIVE COMPARATOR

Standard therapy with glucose target 140-180 mg/dL (ADA guidelines) and masked CGM

Device: Blinded CGM

Intensive Target Group

EXPERIMENTAL

Intensive therapy with glucose target 90-130 mg/dL with real-time CGM

Device: real-time CGM

Interventions

Blinded CGM DEVICE

A masked CGM sensor will be worn

Also known as: Commercially available Dexcom CGM

Standard Target Group

real-time CGM DEVICE

An unmasked CGM sensor will worn

Also known as: Commercially available Dexcom CGM

Intensive Target Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years old
• Type 2 diabetes (per investigator assessment); or if not previously diagnosed as having diabetes, HbA1c\>=7.0% (laboratory-measured at or since hospital admission or within prior 3-months).
• Type 1 diabetes, atypical forms of diabetes (including pancreatectomy and pancreatitis) and stress hyperglycemia alone are not eligible.
• At least 1 blood glucose measurement \>180 mg/dL since admission
• Insulin already initiated since admission or planned to be initiated
• Non-critical hospitalization with expected length of stay on non-ICU floor \>3 days at time of randomization

You may not qualify if:

• Inability to provide written consent
• Admission to ICU
• Patients transferred from ICU with an expected length of stay \>3 days on a non-ICU floor are eligible
• Treatment with systemic immunosuppressive agents such as high dose (\>7.5 mg/day Prednisone equivalent) steroids or biologics that are not regimented and have been started within the last 3 months at time of enrollment or planned treatment prior to randomization.
• Suspected or confirmed acute myocardial infarction or stroke as reason for hospital admission or since admission
• Considered unlikely to survive hospitalization per investigator's judgment
• Diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the 6 months prior to hospital admission, at hospital admission or prior to randomization during the current hospital admission
• One or more severe hypoglycemic events within the 6 months prior to hospital admission or prior to randomization during the current admission
• For females, pregnant or breastfeeding
• A negative serum or urine pregnancy test will be required for all females of child-bearing potential.
• CGM other than study CGM being used during hospitalization or planned to be used
• Blood glucose \>400 mg/dL at time of potential enrollment (most recent blood glucose measurement in hospital)
• Insulin pump being used to deliver insulin during hospitalization or planned to be used
• Use of IV insulin at time of potential enrollment
• Hypoxia (O2 saturation \<90) present at time of potential enrollment

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• DexCom, Inc.: collaborator

Study Sites (6)

University of Colorado, Anschutz Inpatient Pavilion 1 and 2

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Baltimore Research and Education Foundation

Baltimore, Maryland, 21201, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Irl Hirsch, MD

  University of Washington

  STUDY CHAIR

• Judy Sibayan, MPH, CCRP

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Roy Beck, MD, PhD

  Jaeb Center for Health Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 26, 2021
• Study Start: May 10, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year post completion
• Access Criteria: Requests are entered on Jaeb Center for Health Research public website which collects name and contact information for individual requesting data along with reason for request, including planned analyses.

Locations

US (6)