Recent studies using magnetic resonance imaging have shown changes in the gray matter of children with a history of hypoglycemia ( 18, 19). In younger children, the prevention of nocturnal hypoglycemia may be particularly important because children may have a higher susceptibility to long-term neurologic damage due to repeated episodes of severe hypoglycemia ( 16, 17). We recently tested such a system in 15–45-year-old participants and found an 81% reduction in the median hypoglycemia area under the curve and a 74% reduction in hypoglycemia lasting >2 h ( 15).
A more sophisticated and potentially more effective approach is to suspend insulin delivery earlier on the basis of a prediction algorithm ( 11– 14). With this system the patient may already be hypoglycemic before insulin is suspended, and with currently available insulins, there is an ∼60-min delay before the effective insulin action has been attenuated sufficiently so that glucose increases above the hypoglycemic threshold ( 9, 10). A system is currently available that will suspend insulin delivery for up to 2 h or until the patient responds to the hypoglycemic alarm when a low-glucose threshold is reached (MiniMed 530G pump in the U.S., MiniMed Paradigm REAL-Time Veo pump in other countries Medtronic MiniMed, Inc., Northridge, CA) ( 7, 8). In a review of patients who had a nocturnal seizure while wearing a CGM device ( 6), the minimum duration of hypoglycemia before the seizure was >2 h, and often, there were 3–4 h of hypoglycemia before the seizure, allowing an opportunity for a system to suspend insulin delivery to prevent a seizure from occurring. One of the benefits of real-time CGM is the ability of these devices to alarm for hypoglycemia however, patients often do not awaken to these alarms ( 5). Several studies have reported a greater relative frequency of severe hypoglycemia during sleeping than during waking hours ( 2– 4).
ROBERT MAZAIKA TRIAL
In a randomized trial in children and adults ( 1) with 36,467 nights of continuous glucose monitor (CGM) data, the glucose level was ≤60 mg/dL (3.3 mmol/L) for at least 10 consecutive min on 8.5% of nights, and on 23% of those nights, the duration was >2 h. In individuals with type 1 diabetes, hypoglycemia frequently occurs overnight and can result in a severe hypoglycemic event.
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