Novel glucose-sensing technology, tight blood-glucose control, and hypoglycemia

Ben Uphouse, Mercer University College of Pharmacy

According to the American Diabetes Association (ADA), tight blood glucose control is defined as maintaining a level as close to normal (nondiabetic) as possible.  Specifically, this means aiming for blood glucose (BG) levels between 70 – 130 mg/dL before meals, less than 180 mg/dL after a meal, and a glycated hemoglobin (A1C) of less than 7%. [1] Tight control is stated to be advantageous for diabetics because it delays onset of macrovascular and microvascular diabetic complications. [2] However, according to the American Diabetes Association (ADA), tight BG levels may be difficult to maintain due to two major problems: potential for hypoglycemia and weight gain. [3]

Novel glucose-sensing technology and hypoglycemia in type 1 diabetes: a multicenter, non-masked, randomized controlled trial [2]
Design Multicenter, prospective, non-masked, randomized, controlled trial; N= 241
Objective To assess whether a flash glucose-monitoring system reduces incidences of hypoglycemia in patients with type 1 diabetes
Study Groups Flash sensor-based glucose monitoring (n= 120); capillary strip monitoring (n= 121)
Methods All patients wore a blinded sensor for 2 weeks, and those with readings for at least 50% of the period were randomly assigned to flash sensor-based glucose monitoring or to self-monitoring of blood glucose (BG) with capillary strips.  Those in the flash sensor group utilized a flash, factory-calibrated, sensor-based, glucose monitoring system.
Duration September 4, 2014 to February 12, 2015
Primary Outcome Measure Change in time in hypoglycemia (70mg/dL) between baseline and 6 months
Baseline Characteristics
Intervention Control
Men: Women, n (%) 77 (65%): 42 (35%) 59 (49%): 61 (51%)
Race, n (%)
White  119 (100%) 119 (99%)
Black 0 1 (1%)
Median age, years (range) 42 (33-51) 45 (33-57)
Median BMI (kg/m2), (%) 25.2 (3.6) 24.8 (3.5)
Screening of A1C (%; mmol/mol) 6.7; 50.1 6.7; 50.2
Insulin administration method, n (%)
Multiple daily injections 81 (68%) 80 (67%)
Continuous subcutaneous insulin infusion 38 (32%) 40 (33%)
Insulin, total daily dose (units), median
Basal 25.7 20.9
Bolus 24.2 22.2
Continuous subcutaneous insulin infusion 41.4 35.9
Results
Time in hypoglycemia at baseline, hours/day (p<0.0001) Time in hypoglycemia at end of study, hours/day (p<0.0001) Net change, hours
Intervention group 3.38 2.03 -1.39
Control group 3.44 3.27 -0.14
Adverse Events Common Adverse Events: Allergic reaction (n= 4), insertion-site symptom (n= 4)
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Novel flash glucose testing reduced the time that type 1 diabetics spent in hypoglycemia.  Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes.

 

Overall, this study is quite useful as it is helping to determine the quality and safety of new blood-glucose monitoring technology.  However, this study only used patients that were well-controlled and were compliant with testing.  I agree with the study authors in that future studies need to be done to assess the technology with patients that are not described as “well-controlled.”

 

References

  1. American Diabetes Association. Tight diabetes control.  http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/tight-diabetes-control.html. Accessed August 22, 2016.
  2. Bolinder J, Antuna R, Geelhoed-duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016.
  3. Available at: http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/tight-diabetes-control.html. Accessed August 22, 2016.

 

 

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