High discontinuation rate for artificial pancreas among youths with type 1 diabetes
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Approximately half of children and young adults with type 1 diabetes who initiated use of a hybrid closed-loop insulin delivery system, also known as an artificial pancreas, were still using the device in auto mode after 6 months, with 30% of youths discontinuing use of the system altogether, according to findings from a real-world study published in Pediatric Diabetes.
“The Medtronic 670G hybrid closed-loop system has potential to improve glycemic control in youths with type 1 diabetes; however, sustained use of hybrid closed-loop may be a challenge for many youth due to the perceived high workload required,” Cari Berget, RN, MPH, CDE, pediatric artificial pancreas research team manager at the Barbara Davis Center for Diabetes in Aurora, Colorado, told Healio. “As hybrid closed-loop systems continue to evolve, it is important to reduce system burdens to ensure sustainability of hybrid closed-loop use long term.”
In an observational study, Berget and colleagues analyzed data from 92 children and young adults with type 1 diabetes who initiated use of the Medtronic 670G hybrid closed-loop system between September 2017 and May 2018 (mean age, 16 years; 50% females; mean HbA1c, 8.8%). Standard training consisted of 1 to 2 weeks using the 670G system in manual mode, followed by training in use of auto mode and follow-up via phone after starting auto mode. Researchers collected prospective data during manual mode use (up to 14 days before starting auto mode), 1 month after starting auto mode (during a training follow-up call) and during routine clinic visits, occurring approximately every 3 months, during the first 6 months of auto mode use. In auto mode, the system automatically controls basal insulin delivery based on continuous glucose monitoring data, but requires users to enter carbohydrate and blood glucose numbers for boluses. Researchers assessed glycemic variables (sensor time in recommended glucose range, HbA1c) and psychosocial variables (Hypoglycemia Fear Survey; Problem Areas in Diabetes survey). Mixed models were used to analyze changes across time.
Within the cohort, participants used auto mode for 65.5% of the time during month 1, with auto mode use decreasing to 56.2% at 3 months and 51.2% at 6 months (P = .001). CGM use also declined from 80.2% at baseline to 72.4% at 3 months and 68.1% at 6 months (P = .001).
“Ten youth discontinued auto mode within the first 3 months of use,” the researchers wrote. “By 6 months, an additional 18 youth discontinued auto mode, resulting in a total of 28 youth (30% of participants) discontinuing auto mode in the first 6 months of use. Of the 28 youth who discontinued auto mode, 21 also stopped using CGM.”
Sensor time in range increased for the cohort from 50.7% at baseline to 56.9% at 6 months (P = .007). HbA1c decreased from 8.7% at baseline to 8.4% at 6 months (P < .0001), with the greatest HbA1c decline observed among participants with a high baseline HbA1c, according to researchers.
Researchers also found that an increased percent time in auto mode was associated with lower HbA1c (P = .02).
Researchers did not observe changes in psychosocial variables during the observation period.
The researchers noted that the findings present a “mixed picture” of opportunities and challenges for artificial pancreas use among youths, and identified issues for consideration in future studies and clinical practice.
“In our study, 75% of youths who discontinued hybrid closed-loop use also stopped using the CGM, suggesting that CGM use may be the rate limiting factor in ensuring success with hybrid closed-loop therapy,” Berget said. “It is important that clinicians assess individual barriers to CGM use and provide psychosocial and educational support to assist youth in overcoming these barriers to ensure success with hybrid closed-loop therapy.” – by Regina Schaffer
For more information:
Cari Berget, RN, MPH, CDE, can be reached at the Barbara Davis Center for Diabetes, 1775 Aurora Court, Aurora, CO 80045; email: cari.berget@cuanschutz.edu.
Disclosures: The authors report no relevant financial disclosures.
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Gregory Goodwin, MD
This study by the Barbara Davis group was very well done. I am amazed at how similar the data are between our two studies (Goodwin G, et al. OR14-5: Challenges in implementing hybrid closed-loop insulin pump therapy [Medtronic 670g] in a ‘real world’ clinical setting. Presented at: The Endocrine Society Annual Meeting; March 23-26, 2019; New Orleans). For both studies, there are similar dropout rates and similar data on improvement in HbA1c, with the caveat that our study showed that beyond 6 months, the differences in HbA1 were no longer statistically significant. Our data also demonstrated that, with longer follow-up, the “drop rate” increases even further, whereas improvement in HbA1c decreases even further. We even have near identical reports of average time spent in auto mode at 6 months (averaging 50%).
The authors included questionnaires on perception of disease burden and concerns about hypoglycemia and found no change in these quality of life indicators before and after implementation of hybrid closed-loop. The authors also point out that problems with calibrating the sensor and difficulties in staying in auto mode were major obstacles for many patients. The authors also show data indicating that patients with the poorest control at the start of the study showed the greatest improvements in HbA1c.
In my experience, although we have had a few long-term successes with the 670G hybrid closed-loop system, we have had almost no new startups using this system during the past year. This is a reflection of the excessive demands of 670G. The remarkable ease of use of the Dexcom G6 sensor has made this sensor technology a clear favorite among patients, diabetes educators and endocrinologists in our clinic.
A recent presentation at the International Society of Pediatric and Adolescent Diabetes in Boston in October showed outcome data using the Tandem pump/G6 hybrid closed-loop system. This study also showed very modest improvements in HbA1coverall and that the greatest improvements in glycemic control occurred during the overnight period.
Hybrid closed-loop technology struggles with achieving postprandial glycemic control. We see significant hyperglycemic spikes after meals, even when appropriate premeal bolus times are implemented.
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