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Use of artificial pancreas, pump therapy result in similar patient-reported outcomes

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November 1, 2016

Patients with type 1 diabetes assigned to use both an evening and nighttime artificial pancreas and sensor-augmented pump therapy reported a similar decrease in fear of hypoglycemia and increase in treatment satisfaction after using both technologies, according to results from a randomized crossover study.

“Reduced ‘intention to use’ and no improvement over sensor-augmented pump therapy might be a consequence of the developmental stage of the product, including frequent technical errors and reduced ease of use compared with the [continuous glucose monitor] and insulin pump used in this study, which were at the grade of commercial products,” Jort Kropff, MD, of the Academic Medical Center in Amsterdam, and colleagues wrote. “Participants appear to appreciate the positive effects of the artificial pancreas on glucose regulation, but technical errors and reduced usability diminish their appreciation for the system.”

Kropff and colleagues analyzed patient-reported outcomes from 32 patients with type 1 diabetes and an HbA1c of at least 7.5% randomly assigned to 8 weeks of evening and night closed-loop glucose control using an artificial pancreas, followed by 8 weeks of sensor-augmented pump therapy with continuous glucose monitoring (CGM), or vice versa (18 women; mean age, 47 years; mean diabetes duration, 29 years). Intervention periods were separated by a 4-week washout period to minimize carryover effects. Patients completed three self-report questionnaires at baseline and end of treatment periods: the Hypoglycemia Fear Survey-II (HFS-II); the Diabetes Treatment Satisfaction Questionnaire (DTSQ); and the artificial pancreas acceptance questionnaire. A subset of patients (n = 6) participated in in-person interviews after completion of both study arms. Researchers used a repeated-measures analysis of variance (ANOVA) model or paired t test to compare outcomes. Before the present study, 14 participants reported taking part in one or more previous artificial pancreas studies.

Total artificial pancreas acceptance questionnaire score at the end of the artificial pancreas period was 69.1 (95% CI, 63.5-74.7), indicating a positive attitude toward the artificial pancreas. Researchers observed no between-treatment differences among scores at baseline, end of sensor-augmented pump therapy period or end of the artificial pancreas period for fear of hypoglycemia (mean baseline score, 28.2; mean sensor therapy score, 23.5; mean artificial pancreas score, 23.5; P = .099), or diabetes treatment satisfaction (mean baseline score, 29, mean pump therapy score, 28.2; mean artificial pancreas score, 28; P = .43).

In in-person interviews, patients reported “positive effects at work,” “improved blood glucose” and “fewer worries about blood glucose;” however, patients also spoke of frequent alarms, technologic issues and demand for an all-in-one device.

“We can conclude that the artificial pancreas is ready for real-life testing, but technological issues need to be fixed and further development [must] take place before it will be fully acceptable for people with diabetes and thus can be commercialized,” the researchers wrote. “Psychosocial factors of insulin automation technology should again be studied in the next-generation artificial pancreas systems in a more diverse population to evaluate device trust and to obtain an understanding of the implications of letting the device manage the disease, as these were currently difficult to investigate.” – by Regina Schaffer

Disclosure: Two of the study authors hold patent applications related to the study control algorithms. Please see the full study for the other authors’ relevant financial disclosures.