A Randomized Trial of a Home System to Reduce Nocturnal Hypoglycemia in Type 1 Diabetes

Abstract

OBJECTIVEOvernight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels.RESEARCH DESIGN AND METHODSFollowing an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15–45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which ≥1 CGM glucose values ≤60 mg/dL occurred.RESULTSOvernight hypoglycemia with at least one CGM value ≤60 mg/dL occurred on 196 of 942 (21%) intervention nights versus 322 of 970 (33%) control nights (odds ratio 0.52 [95% CI 0.43–0.64]; P < 0.001). Median hypoglycemia area under the curve was reduced by 81%, and hypoglycemia lasting >2 h was reduced by 74%. Overnight sensor glucose was >180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was >180 mg/dL following 21% and 27% of nights, respectively (P < 0.001), and >250 mg/dL following 6% and 6%, respectively. Morning ketosis was present <1% of the time in each arm.CONCLUSIONSUse of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis.

Efficacy of an Overnight Predictive Low-Glucose Suspend System in Relation to Hypoglycemia Risk Factors in Youth and Adults With Type 1 Diabetes

“…The protocol was approved by each Institutional Review Board and informed consent and assent was obtained as appropriate. The study has been described elsewhere 1,2 and listed on the ClinicalTrials.gov website (clinical trial registration numbers NCT01823341 and NCT01591681); key aspects of the study protocols are described below.…”

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

“…These benefits might be achieved at the expense of mildly elevated overnight and morning mean glucose levels [24,25] and a slightly increased time in mild hyperglycemia depending on the algorithmic approach [24]. …”

“…We identified two randomized controlled trials assessing the effectiveness and safety of overnight use of predictive low glucose suspend in outpatient home settings in children aged 1-14years [24] and adolescents and adults aged 15-45years [25]. An algorithm different from that used by 640G pump was used.…”

De la bomba de insulina y el monitoreo continuo de glucosa al páncreas artificial

“…Los umbrales de glicemia para dicha suspensión son programados individualmente para cada paciente. La auto-suspensión por parte de estos equipos ha demostrado ser segura [12][13][14] .…”

“…El uso de MCG-TR en el contexto de SAPT con suspensión automática de la infusión de insulina reduce de forma significativa la tasa, duración y severidad de los episodios de hipoglicemia, sin deterioro del control glicémico [12][13][14][27][28][29] .…”