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TIGHT investigators share lessons learned from evaluating inpatient CGM


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4 minutes

Currently, no continuous glucose monitoring (CGM) systems have been formally approved by the U.S. Food and Drug Administration (FDA) for use in inpatient settings; most CGM devices are optimized for home and patient use. However, CGM devices are increasingly used in hospitals, and CGM use was granted a non-objection by the FDA in 2020.

Guillermo Umpierrez, MD, CDCES, MACP, FACE
Guillermo Umpierrez, MD, CDCES, MACP, FACE

In the Time in Glucose Hospital Target (TIGHT) study, investigators sought to test the hypothesis that CGM-aided glycemic management in patients with type 2 diabetes in a non-intensive care unit hospital setting could improve glycemic control without increasing hypoglycemia compared to standard care. They found no significant difference in mean blood glucose, the primary endpoint, or hypoglycemic range, the secondary endpoint, among participants.

Investigators shared their findings in the symposium Results from a Randomized Trial of Intensive Glucose Management Using Continuous Glucose Monitoring (CGM) Versus Usual Care in Hospitalized Adults with Type 2 Diabetes—The TIGHT Study on Monday, June 24. The session can be viewed on-demand by registered meeting participants on the virtual meeting platform. If you haven’t registered for the 84th Scientific Sessions, register today to access the valuable meeting content through Aug. 26.

Despite the lack of improvement in glycemic control with CGM use in TIGHT, Guillermo Umpierrez, MD, CDCES, MACP, FACE, Professor of Medicine, Emory University, said, “I am very optimistic that in the next couple of years we will move away from the finger sticks of the past 50 years to a better way of determining hypo/hyperglycemia.”

Jagdeesh Ullal, MD, MS, FACE, FACP, ECNU
Jagdeesh Ullal, MD, MS, FACE, FACP, ECNU

TIGHT enrolled patients aged 18 or older with type 2 diabetes with an A1C ≥7 percent and at least one blood glucose measurement >180 mg/dL since admission, explained Jagdeesh Ullal, MD, MS, FACE, FACP, ECNU, Clinical Associate Professor of Medicine and Clinic Lead for Inpatient and Subspecialty Diabetes, University of Pittsburgh Medical Center. He described the study design and summarized the baseline characteristics of the study population.

Of the 166 patients randomized to intensive (blood glucose target, 90−130 mg/dL) or standard (blood glucose target, 140−180 mg/dL) treatment, 110 had sufficient CGM data to include in the primary analyses. Notably, the mean A1C was 8.9 percent, and 72 percent were receiving insulin before admission.

Boris Draznin, MD, PhD
Boris Draznin, MD, PhD

Mean blood glucose was comparable between the groups, Dr. Umpierrez reported, and <10 percent of patients had mean blood glucose of 90−130 mg/dL in either group. Time in hypoglycemic range (<52 mg/dL) also did not differ.

Dr. Umpierrez said that one of the key lessons was that the higher A1C is at admission, the harder it is to manage blood glucose during the hospital stay.

“The most important question in contemporary diabetology, particularly in inpatient settings, is whether controlling hyperglycemia to near normal levels is important for outcomes of a given hospitalization, especially in a non-critical care center,” said Boris Draznin, MD, PhD, Visiting Clinical Professor of Medicine-Endocrinology, Metabolism, and Diabetes, and Director of the Adult Diabetes Program, University of Colorado, who detailed the rationale for the study. However, the concern about hypoglycemia risk is a major rate-limiting step in assessing this question in the inpatient setting.

Irl B. Hirsch, MD
Irl B. Hirsch, MD

The TIGHT study was initiated because “it became imperative to design a glycemia management approach” for normalizing glycemia in hospitalized patients without increasing hypoglycemia, Dr. Draznin explained.

Irl B. Hirsch, MD, Professor and Diabetes Treatment and Teaching Chair at the University of Washington (UW) School of Medicine and UW Medicine Diabetes Institute, discussed the challenges in designing and implementing a multi-hospital study like TIGHT.

“This was a very difficult study,” he said, listing challenges such as use of institution-specific protocols for glycemic management that were neither uniform nor standardized for the study, nursing shortages, and lack of research nurses.

Dr. Hirsch also spoke about the absence of algorithms for intensifying treatment with insulin for hospitalized patients with type 2 diabetes with A1C levels higher than 9 percent. Even though TIGHT study patients were not enrolled with complex diagnoses and were representative of patients often seen in academic and community hospitals, reaching blood glucose targets was extremely difficult in the inpatient setting, even with CGM, he noted.

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