Over the past year, ground-breaking diabetes research studies have looked beyond simply lowering blood sugar to controlling other harmful impacts of a disease that affects more than 415 million adults worldwide and can cause a myriad of complications.
The findings bolster a welcome change in managing diabetes, according to Ashlyn Smith, PA-C, president of the American Society of Endocrine Physician Assistants.
“There has been a shift from a glucose-centric approach to really treating all aspects of the disease, a moving away from just lowering A1C and lowering blood sugar to really treating the whole patient,” Smith, who works at Endocrinology Associates, P.A., in Scottsdale, Arizona, tells Florence Health.
In particular, Smith has concerns with the importance placed on the A1C blood test because it’s actually just an average of blood-glucose levels from the previous three months. This means that even if the A1C is within a satisfactory range, the person’s actual blood sugar could have reached ranges that increase the risks of renal or cardiovascular and other adverse outcomes.
That’s why Smith cites these four drug trials and one set of recommendations, all published in journals this year, as some of the most promising research for reducing diabetes complications. Here’s a rundown and the long-term impact of each:
The landmark “Dapaglifozin Effect on CardiovascuLAR Events—Thrombolysis in Myocardial Infarction 58″ (DECLARE-TIMI 58) trial
Published in January in the New England Journal of Medicine, it’s the largest trial to assess the cardiovascular benefits of a particular class of diabetes medication. For a median of four years, it followed more than 17,000 type 2 diabetics with either established atherosclerotic cardiovascular disease (41 percent of the sample) or with multiple risk factors (59 percent) and tested the impact of the sodium-glucose-co-transporter-2 (SGLT2) inhibitor dapagliflozin.
Findings: The group taking the A1C-lowering drug (brand name Farxiga, which is made by study sponsor AstraZeneca) saw 27 percent fewer hospitalizations for heart failure compared to the placebo group. The trial also suggested patients on dapagliflozin experienced less progression of renal disease. Finally, the drug proved safer than previously thought, with no increased risk of strokes, amputations or fractures compared to the control group.
Impact: Farxiga, which received an additional FDA approval, can improve outcomes for diabetics by helping to reduce the risk of hospitalization from heart failure in adults with type 2 diabetes.
The novel “Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation” (CREDENCE) study
Published in June’s NEJM, it assessed the SGLT2 canagliflozin (brand name Invokana) as a protection against renal disease, which nearly half of all people with type 2 diabetes will develop. The 4,401-participant trial funded by Janssen, which makes the drug, is the first to look at individuals living with diabetes and chronic kidney disease. It ended prematurely due to Invokana’s efficacy.
Findings: Researchers found Canagliflozin reduced the risk of kidney failure in type 2 diabetics with kidney disease by 30 percent compared to the placebo group. The drug also showed cardio-vascular benefits.
Impact: Invokana is the first new therapy in more than 15 years that helps diabetics with kidney disease by slowing down its progression.
The long-running, Eli Lilly-sponsored study “Researching Cardiovascular Events With a Weekly Incretin in Diabetes” (REWIND)
Published in The Lancet in June, it looked at the effect of the GLP-1 receptor agonist dulaglutide (brand name Trulicity) on major adverse cardiac events in people with type 2 diabetes. While the trial included both those with and without established cardiovascular disease, REWIND is significant as the first major trial of a diabetes drug to include so many without preexisting cardiovascular disease.
Findings: Among older patients taking dulaglutide — nearly 70 percent of the 9,900 participants were 50 or older — there was a 12 percent decrease in cardiac arrest deaths, nonfatal heart attacks and nonfatal strokes for more than five years. Trulicity also showed renal benefits.
Impact: The research adds to the body of evidence that medications like Trulicity can help with prevention of major cardiac events in those with type 2 diabetes.
National Institutes of Health-funded International Diabetes Closed Loop trial
For the study, published in October’s NEJM, researchers tested a new device in order to assess whether automating insulin delivery might improve sugar-level management for individuals with type 1 diabetes. Relying on a closed-loop system, the Control-IQ technology by Tandem Diabetes Care involves continuous glucose monitoring integrated with a glucose pump and a novel algorithm developed at the University of Virginia that automates insulin delivery. The trial compared the closed-loop system to a sensor-augmented insulin pump, which is not automated and requires input from the wearer.
Findings: Out of a total of 168 participants spanning ages 14 to 71, those using the closed-loop system (112) saw significant increase, from 61 to 71 percent during the trial, in the amount of time spent in the target glucose range of 70 ml/dL to 180 ml/dL. In contrast, users of the sensor-augmented insulin pump (56) held steady at 59 percent of the day in range.
Impact: Control-IQ increases the options for individualized care and for improved long-term outcomes for type 1 diabetics.
Even though continuous glucose monitoring has become more popular as sensor accuracy has improved, successful use in clinical practice remains low, largely because of insufficient guidance on glucose targets. At the 2019 Advanced Technologies & Treatments for Diabetes Congress, physicians, researchers and technology experts updated standards for continuous glucose monitoring, particularly the duration that should be spent within the glucose target range. Those recommendations were endorsed by the American Diabetes Association, among others, and published in the June issue of its journal, Diabetes Care.
Findings: The bottom-line recommendation is that patients with either type 1 or type 2 diabetes who use continuous glucose monitoring should stay within the target range of 70 mg/dL and 180 mg/dL (or 7 percent hemoglobin A1C) for about 17 hours of the day. The guidelines also suggest that those with type 1 diabetes spend less than one hour a day below and less than six hours above the target. Type 2 diabetics should avoid spending more than 15 minutes below 54 mg/dL or more than 72 minutes above 250 mg/dL.
Impact: The recommendations provide a way to standardize continuous glucose monitoring and complement A1C targets. This, in turn, should improve treatment by providing targets that minimize time spent in extreme swings and influencing choices around food intake and exercise.
Dapaglifozin Effect on CardiovascuLAR Events—Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58), New England Journal of Medicine.
Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation” (CREDENCE), New England Journal of Medicine.
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes, New England Journal of Medicine.