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Diabetes Technol Ther. 2017 May;19(5):288-292. doi: 10.1089/dia.2016.0319. Epub 2017 Feb 16.

Evaluation of a Predictive Low-Glucose Management System In-Clinic.

Author information

1
1 Department of Pediatric Endocrinology, Stanford University , Stanford, California.
2
2 AMCR Institute , Escondido, California.
3
3 Diablo Clinical Research , Walnut Creek, California.
4
4 Barbara Davis Center for Diabetes , Aurora, Colorado.
5
5 Department of Pediatrics, Yale University School of Medicine , New Haven, Connecticut.
6
6 Atlanta Diabetes Center , Atlanta, Georgia .
7
7 UVA Center for Diabetes Technology , Charlottesville, Virginia.
8
8 Rainier Clinical Research Center , Renton, Washington.
9
9 Medtronic, Northridge, California.

Abstract

BACKGROUND:

Predictions based on continuous glucose monitoring (CGM) data are the basis for automatic suspension and resumption of insulin delivery by a predictive low-glucose management feature termed "suspend before low," which is part of the Medtronic MiniMed® 640G combined insulin pump and CGM system. This study assessed the safety and performance characteristics of the system in an in-clinic setting at eight sites.

MATERIALS AND METHODS:

In-clinic standardized increases in basal insulin delivery rates were used to induce nocturnal hypoglycemia in subjects (14-75 years) with type 1 diabetes wearing the MiniMed 640G system. The "suspend before low" feature was set at 65 mg/dL, and as a result, the predictive algorithm suspended insulin delivery when the forecasted glucose was predicted to be ≤85 mg/dL in 30 min (a 20 mg/dL safety buffer). Reference plasma glucose values (Yellow Springs Instruments [YSI], Yellow Springs, OH) were used to establish hypoglycemia and were defined as ≥2 consecutive values ≤65 mg/dL.

RESULTS:

Eighty subjects were screened. Among the 69 successful completers, 27 experienced a hypoglycemic event and 42 did not, a prevention rate of 60%. The mean (±standard deviation) YSI value at the time of pump suspension was 101 ± 18.5 mg/dL, and the mean duration of the 68 "suspend before low" events was 105 ± 27 min. At 120 min after the start of the pump suspension events, the mean YSI value was 102 ± 34.6 mg/dL.

CONCLUSION:

The MiniMed 640G "suspend before low" feature prevented 60% of induced predicted hypoglycemic events without significant rebound hyperglycemia.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02130284.

KEYWORDS:

Artificial pancreas; Hypoglycemia; Sensor-augmented pump

PMID:
28221823
DOI:
10.1089/dia.2016.0319
[Indexed for MEDLINE]

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