I am always happy to update the latest information on the “care” of diabetes. We are always interested in the “cure.” However, until that magical day occurs, we need to be practical. Enter this fabulous report on the use of the Artificial Pancreas at Diabetes Camp. A recent publication in the New England Journal of Medicine, “Nocturnal Glucose Control with an artificial pancreas at Diabetes camp,” by Phillip, Battelino, Atlas, et al. (N Engl J Med 2013; 368: 824-833, February 28, 2013) discusses a multinational, prospective, randomized, crossover study at three youth camps (Israel, Slovenia, and Germany regarding the application of the MD-Logic Artificial Pancreas system for nocturnal blood glucose control in patients with type 1 diabetes).
Recent published studies demonstrated that the application of the Artificial Pancreas in hospital settings improves glucose control and reduces the risk of hypoglycemia in all age groups. The barrier to general implementation of the artificial pancreas is determining its safety and effectiveness outside the hospital setting. This study is of major importance since Camp Directors are always concerned about the possibility of exercise induced hypoglycemia overnight due to the increase in physical activity. After three years at Camp Take Charge, in which camp personnel were up at 3 am checking camper’s blood sugars to ensure treatment of lows, the addition of such a device would be so desirable!
The Diabetes Wireless Artificial Pancreas Consortium (DREAM), was developed to test the effectiveness of the MD-Logic Artificial Pancreas system for use outside the hospital in real-life settings. The objective of the current study was to “evaluate the safety and efficacy of the artificial-pancreas system in young persons with type 1 diabetes, with an aim of achieving substantial reduction in nocturnal hypoglycemia with near-normal of overnight glucose control in a youth camp setting.”
Who were the participants?
- Children 10-18 years of age with at least a 1 year history of type 1 diabetes
- Insulin pump therapy for at least 3 months
- Hb A1 between 7-10 percent
- BMI less than 97 percent
- Ability to adhere to trial instructions
Methods: In two consecutive overnight sessions, children were randomly assigned to receive treatment with the artificial pancreas on the first night and a sensor-augmented pump on the second night, or the reverse order of therapies on the first and second night. All children participated in social and physical activities including swimming. At 9 pm, all children were offered a snack and bedtime was between 10:30 and 11 pm. Capillary blood sugars were checked at meals, 2 hours after meals and at bedtime, and then at 3-hour intervals throughout the night.
What were the results?
- On nights when the artificial pancreas was employed versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels less than 63 mg/dl and significantly shorter periods when glucose levels were below 60 mg/dl
- Median values for individual mean overnight blood sugar levels were 126.4 mg/dl with the artificial pancreas and 140.4 mg/dl with the sensor-augmented pump
- NO serious adverse events were reported
What were the conclusions?
“Children at a diabetes camp who were treated with an artificial pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump.”
What were the limitations?
- “Each treatment was evaluated in a one night session and the challenges of a closed-loop system (artificial pancreas) for glucose and insulin control may be different in a multi-night design.”
- A need to perform sensor recalibration during the two study nights.
- Glucose data were based on sensor readings and therefore the performance of the artificial pancreas system and the study endpoints were all based on subcutaneous interstitial sensor glucose measurements. (However, according to the paper, assigned medical personnel checked capillary blood glucose readings every 3 hours. The capillary data did support the efficacy of the artificial pancreas system and confirmed the reported results for the primary outcome of blood sugar<63 mg/dl.)
In summary, the artificial pancreas studies continue to become more promising. Future trials will continue to be employed in everyday settings to confirm safety in all possible environments.
Published On: March 21, 2013