Did you know that roughly 1.6 million Americans currently have type 1 diabetes (ADA 2020)? Type 1 diabetes is a disease that affects the ability of the pancreas to produce insulin. Insulin is a naturally produced hormone that controls blood sugar levels in the body. Therefore, diabetics are not able to passively control their blood sugar levels. Type 1 diabetics must actively test their blood sugar and receive insulin shots in order to control their disease. However, there is a new closed-loop artificial pancreas system that takes some of the pressure off of diabetics.
The FDA approved the first closed-loop control (CLC) system in 2016. Since then there have been many improvements made to the system. Additionally, there have been a multitude of studies conducted utilizing the artificial pancreas. The CLC system has been tested at diabetes camps and outpatient environments, but never when patients are exposed to high exercise. When tested in the home environment, the CLC system was effective. This system reduced the risk of hypoglycemia and resulted in an increased amount of time in ideal blood sugar range (Anderson et al. 2016). Additionally, a study conducted at a summer camp displayed that children felt less burdened by diabetes when using the CLC artificial pancreas system (Fisher et al. 2016). Dr. Marc D. Breton decided to test the CLC system during intense exercise because it imposes new challenges as exercise can cause hypo- or hyperglycemia. Hypoglycemia is when the blood sugar level is too low and hyperglycemia is when the blood sugar level is too high. This study is important because it places the artificial pancreas in a high stress environment. Dr. Breton and his team used skiing as their choice of intense exercise. Skiing also provides other challenging conditions like altitude, temperature, and stress.
Participants for the study were ten to twenty-five years old. They took part in a six-day ski/snowboard camp in either Wintergreen, Virginia or Breckenridge, Colorado. Each day there was about five hours dedicated to on-snow activity. Subjects either wore a remotely monitored censor-augmented pump or the closed-loop control (CLC) system. Those with the censor-augmented pump were the control group for the trial. Additionally, all subjects wore a continuous glucose monitor (CGM) to keep check of their blood sugars. Each member of the study used the first wearable CLC system, the DiAs, connected to their CGM. However, the test group using the CLC system additionally had the DiAs connected to their pumps, and it controlled all insulin delivery. The study team intervened if CGM values were less than 80 mg/dL or greater than 300 mg/dL. Glucose outcomes were then calculated using the CGM records. The team computed the time spent between 70 and 180 mg/dL, quality of glycemic control, and insulin used (Breton et al. 2017).
The data was split up into different sections for skiers with no experience, beginner level, intermediate level, and advanced level skiers. All of the subjects had experience using their pumps. The CLC system resulted in a 71.3 ± 17.6% time in the ideal 70-180 mg/dL range as compared to 64.7 ± 13.3%. Therefore, when utilizing the artificial pancreas system, subjects spent an average of an hour and forty more minutes in range per day. Additionally, the percent time exposed to hyperglycemia greater than 250 mg/dL was reduced from 9.3 ± 10.9% to 7.0 ±8.0%. The exposure to hypoglycemia less than 70 mg/dL decreased the most in the beginner level group. It went from 3.5 to 1.2%, but in the advanced group it only decreased from 2.9 to 2.3%. (Breton et al. 2017).
The data displays that the CLC system does decrease hypoglycemia which is a major concern of diabetics when involved in high intensity exercise. Similarly, there was a decrease in the time spent in hyperglycemia which demonstrates success of the CLC system. The data positively supports the CLC artificial pancreas system as it improved many factors that diabetics need to control. In addition, the technology allows the diabetic to have more freedom as it utilizes significantly less manual input.
There are some limitations when it comes to this study. First, only thirty-three subjects were tested. Thirty-three people does not seem like a big enough sample group to judge the entire population of type 1 diabetics. Additionally, all of the subjects were ten to twenty-five years old. Therefore, this data will not be able to be applied to adult diabetics. There are also limitations to this study given that it is the first of its kind to test the CLC system during intense exercise. The study needs to be replicated in order to understand if the data is reliable.
This study expresses breakthrough technology for the diabetic world. Most people know someone who suffers from diabetes so this study is important in trying to find better ways to improves the lives of diabetics. The CLC system will allow for people to feel less burdened and worried about diabetes. The research also brings attention to the difficulties diabetics face when participating in strenuous exercise. This study will also help to bring greater awareness to the diabetic community. Additionally, this research will provide an informative background for future studies involving the CLC artificial pancreas system during prolonged exercise.
References
[ADA] American Diabetes Association. 2020. Statistics about diabetes. American Diabetes Association. https://www.diabetes.org/resources/statistics/statistics-about-diabetes.Anderson S, Avogaro A, Beck R, Bevier W, Boscari F, Bradley P, Breton M, Brown S, Bruttomesso D, Buckingham B, Calore R, Chernavvsky D, Cobelli C, Dasanayake I, Dassau E, Del Favero S, Doyle F, Farret A, Keith-Hynes P, Kollman C, Kovatchev B, Lum J, Ly T, Nimri R, Phillip M, Pinsker J, Place J, Raghinaru D, Renard E, Shanmugham S. 2016. Multinational hone use of closed-loop control is safe and effective. Diabetes Care. 39(7):1143-1150. https://pubmed.ncbi.nlm.nih.gov/27208316/. doi:10.2337/dc15-2468.
Breton M, Chernavvsky D, DeBoer M, Forlenza G, Kovatchev B, Maahs D, Messer L, Robic J, Wadwa R. 2017. Closed-loop control during intense prolonged outdoor exercise in adolescents with type 1 diabetes: the artificial pancreas ski study. Diabetes Care. 40:1644-1650. https://pubmed.ncbi.nlm.nih.gov/28855239/. doi:10.2337/dc17-0883.
Fisher L, Hessler D, Polonsky W, Weissberg-Benchell J. Psychosocial impact of the bionic pancreas during summer camp. Journal of Diabetes Science and Technology. 10(4):840-844. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4928236/. doi:10.1177/1932296816640289.
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