[리서치페이퍼= Vittorio Hernandez 기자] Type 1 diabetics aged between 7 and 13 who used an artificial pancreas for three months reported a reduction in HbA1C without any episodes of severe hypoglycemia or diabetic ketoacidosis. Although diabetes management with children is a challenge, experts said that the MiniMed 670G system may provide means to address and improve glycemic control in some patients with type 1 diabetes.
The US Food and Drug Administration approved the MiniMed 670G in October 2016 and launched it in the US in June 2017, Healio reported. The system has the SmartGuard HCL technology of Medtronics and the Guardian Sensor 3. It is the only insulin pump with FDA’s approval that enables personalized and automated delivery of basal insulin.
Only for kids 14 years and older
Blood sugar level is monitored by using the Contour Next Link 2.4 blood glucose monitoring system, the Ascencia Diabetes Care. However, there is no FDA approval for the use of MiniMed 670G on kids who are 14 years old or younger.
Dr. Michael Alan Wood, an associate professor of pediatrics and the clinical director of the pediatric diabetes program at the University of Michigan Medical School in Ann Arbor, said that data from a single-arm study showed that their mean baseline HbA1c was 7.9 percent during the time that they had diabetes for 5.6 years. The mean age was 11 years old of which 49 were girls with a BMI of 19.1 kg/m2.
For at least five months, the participants used insulin pump therapy in eight US sites and in one Israel site. An in-clinic evaluation was held in which the kid used the MiniMed system in open-loop, manual mode for two weeks.
Then they shifted to a closed-loop automatic mode for three months. The researchers changed the study endpoints in HbA1C from the baseline to three months which resulted in reports of severe hypoglycemia and DKA.
The next step was for the scientists to compare the data for the cohort with data from similar trials which had 30 adolescent volunteers aged 14 to 21 years old and 94 adult participants aged 22 to 75-years-old.
Wood disclosed that there was an improvement in HbA1c from a mean of 7.9 percent to 7.5 percent. There was also a noticeable overall variability of sensor glucose values, while the total daily dose of insulin slightly went up from a mean of 0.8 units per day to 0.9 units per day.
The marked improvement in time spent in the target blood glucose range of 71 mg/dl which went up to 65 percent from 56 percent excited most of the researchers. They compared the results to those observed in adolescents and adult groups that logged a time-in-range improvement to 67 percent from 60 percent and 68 percent to 78.3 percent respectively over three months of using the artificial pancreas.
Artificial pancreas production to begin in 2nd half of 2018
Digitimes reported that image solution provider Altek developed artificial pancreas that meets standards for developing medical devices. The Taipei-based firm will begin production in the second half of 2018. International device vendors commissioned Altek to develop hardware and software for artificial pancreas devised to release insulin.
The market is wide because there are 425 million diabetes patients around the world in 2017, according to the International Diabetes Federation.
Relaxing blood sugar targets
Meanwhile, a new set of global guidelines on the management of diabetes that seeks to replace the guidelines for 30 years has created controversy within the medical community, Times of India reported.
The new guidelines recommended relaxing blood sugar targets. The medical practitioners pointed out that it will only result in serious complications in diabetes and confusion in the treatment protocol. Indian doctors advised fellow physicians to ignore the guidelines for Indians where there are 72 million diagnosed cases of diabetes, the IDF estimated.
Hemoglobin A1C, the long-term blood sugar target, which provides an estimate of a patient’s glucose level average over the past few months is proposed to be relaxed. The new guidelines, released recently by the American College of Physicians, said that there should be personalized goals for blood sugar control based on a discussion of drug therapy, patient preferences, treatment burden, and costs of the care.
In most patients, the target is to reach an HBA1c level between 7 percent and 8 percent. But the college considers generally an HBA1c target of 6.5 percent is an indicator of diabetes. Indian doctors said that the guideline bringing down the blood glucose level target cannot be binding and should be set aside. They noted that diabetes in India is more aggressive and marked with complications.
They cited three bodies that are more tuned in to the India diabetes patients. These are the Indian Council of Medical Research, Research Society For The Study of Diabetes in India, and the Association of Physicians in India.
[researchpaper 리서치페이퍼= Vittorio Hernandez 기자]