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Post-bariatric hypoglycaemia

Drug delivery system combats post-bariatric hypoglycaemia

Side effects of the study medication were minimal and included temporary pain where the treatment entered the body.

A new automated drug delivery system can help prevent dangerously low blood sugar in patients who have undergone weight-loss surgery, according to a study, ‘OR22-3: Closed-Loop Glucagon Pump: A Novel and Effective Strategy for Post-Bariatric Hypoglycemia’, presented at ENDO 2019, the Endocrine Society's annual meeting in New Orleans, LA.

An increasingly recognised complication of weight-loss surgery is low blood sugar, or post-bariatric hypoglycaemia (PBH). This condition can cause severe and debilitating low blood sugars after meals. Severe untreated hypoglycaemia can cause seizures, loss of consciousness and death.

"Currently available treatments are not always effective for severely affected patients," said lead researcher, Dr Christopher M Mulla of Joslin Diabetes Center in Boston, MA. "This study demonstrated that our glucagon automated delivery system can detect imminent low blood sugar and deliver a small dose of glucagon, yielding improvements in blood glucose levels after meals and reducing severe hypoglycaemia in patients with PBH. Further research and development of this system will help treat this challenging disease."

The researchers tested a new automated drug delivery system, similar to an insulin pump, which can detect when glucose levels are dropping quickly and deliver the hormone glucagon to patients to prevent low blood sugar. A novel hypoglycaemia detection and mitigation algorithm was embedded in the Artificial Pancreas System connected to a continuous glucose monitor (CGM, Dexcom) driving a patch infusion pump (Insulet) filled with study drug (Xeris liquid glucagon or vehicle).

The study included 12 participants (11 women and one man) with PBH who had undergone weight-loss surgery an average of eight years earlier; their average age was 52. They wore continuous glucose monitors and an automated pump system, filled with glucagon on one day and a placebo on the second day. Neither the participants nor the study team knew what the pumps contained. Participants were given a liquid meal on both days, and the device measured their glucose levels.

The system autonomously delivered up to 2 doses of study drug (300/150 mcg of glucagon or equal volume vehicle) if triggered by the hypoglycaemia mitigation algorithm. If plasma glucose fell to <55 mg/dL or neuroglycopenia occurred, rescue IV dextrose was given per protocol. During a 2nd study visit, the protocol was repeated, with pump filled with the other study drug. Twelve participants (11F/1M, age 52+2, postoperative duration 8+1 years, mean+SEM) completed all study visits.

For the 12 participants receiving glucagon vs. vehicle during two study visits, predictive hypoglycaemia alerts prompted automated drug delivery at mean 94+6 vs. 89+5 (p=0.41) minutes post meal, when sensor glucose was 114+7 vs. 121+5 mg/dL (p=0.39). Four participants did not require rescue during either visit; one participant required rescue during both visits. Seven participants required rescue glucose after vehicle but not after glucagon (p=0.0082).

Similarly, five participants had severe hypoglycaemia (plasma glucose <5 mg/dL) after vehicle but not after glucagon (p=0.03). Nadir plasma glucose was higher in study visits with glucagon vs. vehicle delivery (67.4±2.7 vs. 58.5±1.9mg/dL, p=0.004). Glucagon levels were not elevated at time of alert (14.6±1.4pg/mL) but rose after glucagon delivery (1231±187 vs. vehicle 16 ±1.4pg/mL at 30 minutes, p=0.001). No rebound hyperglycemia occurred. Emesis occurred before study drug delivery in two visits. Transient pain at infusion site was reported during both glucagon (n=11 of 12) and vehicle (n=10 of 12) study visits. No other adverse advents were observed.

Glucose levels were higher on the day they received glucagon than on the day they received a placebo. This indicates that the glucagon was effective at preventing severe low blood sugar, Mulla said. Side effects of the study medication were minimal and included temporary pain where the treatment entered the body.

The team of researchers included engineers from Harvard Paulson School of Engineering and Applied Sciences led by Dr Eyal Dassau, and the endocrinology team led by Dr Mary Elizabeth Patti at Joslin.

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