Themes, Rates, and Risk of Adverse Events of the Artificial Pancreas in the United States Using MAUDE.

Three manufacturers sell artificial pancreas systems in the United States for management of Type 1 Diabetes. Given the life-saving task required of an artificial pancreas there needs to be a high level of trust and safety in the devices. This evaluation sought to find the adjusted safety event reporting rate and themes along with device-associated risk in events reported utilizing the MAUDE database. We searched device names in the MAUDE database over the period from 2016 until August 2023 (the date of retrieval). Thematic analysis was performed using dual-reviewer examination with a 96% concurrence. Relative risk (RR) was calculated for injury, malfunction, and overall, for each manufacturer, as well as adjusted event rate per manufacturer. Most events reported related to defects in the manufacturing of the casing materials which resulted in non-delivery of therapy. Tandem Diabetes Care, Inc. had an adjusted event rate of 50 per 100,000 units and RR of 0.0225. Insulet had an adjusted event rate of 300 per 100,000 units and RR of 0.1684. Medtronic has an adjusted event rate of 2771.43 per 100,000 units and RR of 20.7857. The newer Medtronic devices show improvements in likely event rate. While the artificial pancreas is still in its infancy, these event rates are not at an acceptable level for a device which can precipitate death from malfunctions. Further exploration into safety events and much more research and development is needed for devices to reduce the event rates. Improved manufacturing practices, especially the casing materials, are highly recommended. The artificial pancreas holds promise for millions but must be improved before it becomes a true life-saving device that it has the potential to become.

Integration of a Safety Module to Prevent Rebound Hypoglycemia in Closed-Loop Artificial Pancreas Systems.

BACKGROUND: With automated insulin delivery (AID) systems becoming widely adopted in the management of type 1 diabetes, we have seen an increase in occurrences of rebound hypoglycemia or generated hypoglycemia induced by the controller's response to rapid glucose rises following rescue carbohydrates. Furthermore, as AID systems aim to enable complete automation of prandial control, algorithms are designed to react even more strongly to glycemic rises. This work introduces a rebound hypoglycemia prevention layer (HypoSafe) that can be easily integrated into any AID system. METHODS: HypoSafe constrains the maximum permissible insulin delivery dose based on the minimum glucose reading from the previous hour and the current glucose level. To demonstrate its efficacy, we integrated HypoSafe into the latest University of Virginia (UVA) AID system and simulated two scenarios using the 100-adult cohort of the UVA/Padova T1D simulator: a nominal case including three unannounced meals, and another case where hypoglycemia was purposely induced by an overestimated manual bolus. RESULTS: In both simulation scenarios, rebound hypoglycemia events were reduced with HypoSafe (nominal: from 39 to 0, hypo-induced: from 55 to 7) by attenuating the commanded basal (nominal: 0.27U vs. 0.04U, hypo-induced: 0.27U vs. 0.03U) and bolus (nominal: 1.02U vs. 0.05U, hypo-induced: 0.43U vs. 0.02U) within the 30-minute interval after treating a hypoglycemia event. No clinically significant changes resulted for time in the range of 70 to 180 mg/dL or above 180 mg/dL. CONCLUSION: HypoSafe was shown to be effective in reducing rebound hypoglycemia events without affecting achieved time in range when combined with an advanced AID system.

What is the optimal range of glycemic control for non-diabetic patients undergoing gastroenterological surgery? A single-center randomized controlled trial using an artificial pancreas.

BACKGROUND: This study aimed to determine the optimal target range of perioperative glycemic control for gastroenterological surgery. A closed-loop-type artificial pancreas (AP) was used to diminish the negative impact of hypoglycemia and glycemic variability during tight glycemic control. METHODS: In this single-center randomized trial, non-diabetic patients were assigned to tight (80-110 mg/dL) or moderate glycemic control (110-140 mg/dL) groups between August 2017 and May 2021. AP was used from the intraoperative period until discharge from the intensive care unit. The primary endpoint was the serum interleukin (IL)-6 level on the third postoperative day (3POD), and the secondary endpoints included clinical outcomes. RESULTS: Recruitment was closed before reaching the planned number of patients due to slow enrollment. Tight glycemic control (n = 62) resulted in lower mean glucose levels than moderate glycemic control (n = 66) (121.3 ± 10.8 mg/dL vs. 133.5 ± 12.0 mg/dL, p < 0.001). Insulin was administered at a 65% higher rate for tight glycemic control, achieving appropriate glucose control more than 70% of the treatment time. No hypoglycemia occurred during the AP treatment. No significant difference was observed in serum IL-6 levels on 3POD (23.4 ± 31.1 vs. 32.1 ± 131.0 pg/mL, p = 0.64), morbidity rate, surgical mortality rate, or length of hospital stay between the two groups. CONCLUSIONS: Clinically relevant short-term results did not differ, implying that 80-110 and 110-140 mg/dL are permissible glycemic control ranges when using AP in non-diabetic patients undergoing gastroenterological surgery. (Registered in UMIN; UMIN000028036).

Effect of intensive insulin therapy on inflammatory response after cardiac surgery using bedside artificial pancreas: A propensity score-matched analysis.

BACKGROUND: Perioperative hyperglycemia leads to poor postoperative clinical outcomes, including compromised immune function, cardiovascular events, and mortality. The optimal perioperative blood glucose levels during cardiac surgery remain unclear. A closed-loop glycemic control system (artificial pancreas, target blood glucose range:120-150 mg/dl) prevents postoperative inflammatory response more effectively than conventional insulin therapy (<200 mg/dl). However, the clinical effects of intensive insulin therapy with strict glycemic control (80-110 mg/dl) are controversial. This study aimed to determine whether intensive insulin therapy would further suppress postoperative inflammatory reactions. METHODS: This study analyzed 262 patients who underwent cardiovascular surgery with cardiopulmonary bypass. The patients were divided into two groups according to their target blood glucose range: 80-110 mg/dl and 120-150 mg/dl. The primary outcome was the difference in the C-reactive protein levels between the two groups. RESULTS: Propensity score matching resulted in 95 patients in each group based on their covariates. There was no difference in the postoperative maximum C-reactive protein levels between the two groups (14.81 ± 5.93 mg/dl vs. 14.34 ± 5.52 mg/dl; p = 0.571) following propensity score matching. Hypoglycemia did not occur during intensive insulin therapy. CONCLUSIONS: Intensive insulin therapy following cardiac surgery with cardiopulmonary bypass did not demonstrate significant advantages in the suppression of postoperative inflammatory reactions compared to that with mild glycemic control. However, intensive insulin therapy using an artificial pancreas was found to be safe, with no hypoglycemic events.

Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy: A Randomized Clinical Trial.

Importance: Glucose control in patients after total pancreatectomy is problematic because of the complete absence of α- and ß-cells, leading to impaired quality of life. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking. Objective: To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy. Design, Setting, and Participants: This randomized crossover clinical trial compared the fully closed-loop BIHAP with current diabetes care (ie, insulin pump or pen therapy) in 12 adult outpatients after total pancreatectomy. Patients were recruited between August 21 and November 16, 2020. This first-in-patient study began with a feasibility phase in 2 patients. Subsequently, 12 patients were randomly assigned to 7-day treatment with the BIHAP (preceded by a 5-day training period) followed by 7-day treatment with current diabetes care, or the same treatments in reverse order. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P < .05. Main Outcomes and Measures: The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL [3.9-10 mmol/L]) as assessed by continuous glucose monitoring. Results: In total, 12 patients (7 men and 3 women; median [IQR] age, 62.5 [43.1-74.0] years) were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced. The time spent in euglycemia was significantly higher during treatment with the BIHAP (median, 78.30%; IQR, 71.05%-82.61%) than current diabetes care (median, 57.38%; IQR, 52.38%-81.35%; P = .03). In addition, the time spent in hypoglycemia (<70 mg/dL [3.9 mmol/L]) was lower with the BIHAP (median, 0.00% [IQR, 0.00%-0.07%] vs 1.61% [IQR, 0.80%-3.81%]; P = .004). No serious adverse events occurred. Conclusions and Relevance: Patients using the BIHAP after total pancreatectomy experienced an increased percentage of time in euglycemia and a reduced percentage of time in hypoglycemia compared with current diabetes care, without apparent safety risks. Larger randomized trials, including longer periods of treatment and an assessment of quality of life, should confirm these findings. Trial Registration: trialregister.nl Identifier: NL8871.

Experience with intraoperative use of artificial pancreas during local resection of insulinoma.

A 50-year-old woman was hospitalized for fainting caused by hypoglycemia. Her blood glucose level was low (40 mg/dL), immunoreactive insulin was 16.9 µU/mL, and C-peptide level was high (4.8 ng/mL). Computed tomography and magnetic resonance imaging revealed a 7-mm tumor in the uncinate process of the pancreas. A selective arterial calcium injection test indicated an increase in the superior mesenteric artery. Insulinoma of the uncinate process of the pancreas was diagnosed, and tumor enucleation was planned using an artificial pancreas for intraoperative and postoperative blood glucose control. Hypoglycemia (blood glucose, 38 mg/dL) was observed from the onset of surgery. An artificial pancreas cannot be used if the blood glucose level is ≤ 70 mg/dL; thus, continuous glucose infusion was administered. The sudden rise in blood glucose prompted insulin infusion from the device, causing hypoglycemia. Controlling blood glucose levels is challenging when introducing the artificial pancreas. However, altering the device's blood glucose control algorithm controlled the fluctuating blood glucose level, and, intraoperative average blood glucose was raised to 94.8 ± 21.1 mg/dL, thereby avoiding hypoglycemia, that is, a blood glucose level of ≤ 70 mg/dL. We report a case in which an artificial pancreas was used for glycemic control during surgery for an insulinoma.

Dual-hormone artificial pancreas for glucose control in type 1 diabetes: A meta-analysis.

AIM: To evaluate the efficacy and safety of a dual-hormone artificial pancreas (DH) in type 1 diabetes. MATERIAL AND METHODS: PubMed, Embase, the Cochrane Library and ClinicalTrials.gov were searched for studies published up to February 16, 2022. We included randomized controlled trials that compared DH with single-hormone artificial pancreas (SH), continuous subcutaneous insulin infusion (CSII) or sensor-augmented pumps (SAP), and predictive low glucose suspend systems (PLGS) in type 1 diabetes. The primary outcome was percent time in target (3.9-10 mmol/L [70-180 mg/dL]). Data were summarized as mean differences (MDs) or risk differences (RDs). RESULTS: A total of 17 randomized crossover trials (438 participants) were included. There were nine trials of DH versus SH, 13 trials of DH versus SAP/CSII, and two trials of DH versus PLGS. For time in target, DH showed no significant difference in time in target compared with SH (MD 2.69%, 95% confidence interval [CI] -0.38 to 5.76) but resulted in 16.05% (95% CI 12.06 to 20.05) and 6.89% (95% CI 2.63 to 11.14) more time in target range compared with SAP/CSII and PLGS, respectively. DH slightly reduced time in hypoglycaemia (MD -1.20%, 95% CI -1.85 to -0.56) but increased the risk of gastrointestinal symptoms (RD 0.18, 95% CI 0.08 to 0.27) compared with SH. CONCLUSIONS: The results of this study suggest that DH has a comparable effect on time in target compared with SH, but is associated with a longer time in target range compared with SAP/CSII and PLGS. The DH slightly reduced time in hypoglycaemia but may increase the risk of gastrointestinal symptoms compared with the SH. PROSPERO registration number: CRD42022314015.

Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm.

Objective: Evaluating the feasibility of closed-loop insulin delivery with a zone model predictive control (zone-MPC) algorithm designed for pregnancy complicated by type 1 diabetes (T1D). Research Design and Methods: Pregnant women with T1D from 14 to 32 weeks gestation already using continuous glucose monitor (CGM) augmented pump therapy were enrolled in a 2-day multicenter supervised outpatient study evaluating pregnancy-specific zone-MPC based closed-loop control (CLC) with the interoperable artificial pancreas system (iAPS) running on an unlocked smartphone. Meals and activities were unrestricted. The primary outcome was the CGM percentage of time between 63 and 140 mg/dL compared with participants' 1-week run-in period. Early (2-h) postprandial glucose control was also evaluated. Results: Eleven participants completed the study (age: 30.6 ± 4.1 years; gestational age: 20.7 ± 3.5 weeks; weight: 76.5 ± 15.3 kg; hemoglobin A1c: 5.6% ± 0.5% at enrollment). No serious adverse events occurred. Compared with the 1-week run-in, there was an increased percentage of time in 63-140 mg/dL during supervised CLC (CLC: 81.5%, run-in: 64%, P = 0.007) with less time >140 mg/dL (CLC: 16.5%, run-in: 30.8%, P = 0.029) and time <63 mg/dL (CLC: 2.0%, run-in:5.2%, P = 0.039). There was also less time <54 mg/dL (CLC: 0.7%, run-in:1.6%, P = 0.030) and >180 mg/dL (CLC: 4.9%, run-in: 13.1%, P = 0.032). Overnight glucose control was comparable, except for less time >250 mg/dL (CLC: 0%, run-in:3.9%, P = 0.030) and lower glucose standard deviation (CLC: 23.8 mg/dL, run-in:42.8 mg/dL, P = 0.007) during CLC. Conclusion: In this pilot study, use of the pregnancy-specific zone-MPC was feasible in pregnant women with T1D. Although the duration of our study was short and the number of participants was small, our findings add to the limited data available on the use of CLC systems during pregnancy (NCT04492566).

Perceptions and expectations of adults with type 1 diabetes for the use of artificial pancreas systems with and without glucagon addition: Results of an online survey.

BACKGROUND AND AIMS: The first hybrid artificial pancreas (AP) systems with insulin only (mono-hormonal) have recently reached the market while next generations systems are under development including those with glucagon addition (bi-hormonal). Understanding the expectations and impressions of future potential users about AP systems is important for optimal use of this clinically effective emerging technology. METHODS AND RESULTS: An online survey about AP systems which consisted of 50 questions was addressed to people with type 1 diabetes in the province of Quebec, Canada. Surveys were completed by 123 respondents with type 1 diabetes (54% women, mean (SD) age 40.2 (14.4) y.o., diabetes duration 23.7 (14.1) years, 58% insulin pump users and 43% glucose sensor users). Of the respondents, 91% understood how AP systems work, 79% trusted them with correct insulin dosing, 73% were willing to replace their current treatment with AP and 80% expected improvement in quality of life. Anxiety about letting an algorithm control their glucose levels was expressed by 18% while the option of ignoring or modifying AP instructions was favoured by 88%. As for bi-hormonal AP systems, 83% of respondents thought they would be useful to further reduce hypoglycemic risks. CONCLUSIONS: Overall, respondents expressed positive views about AP systems use and high expectations for a better quality of life, glycemic control and hypoglycemia reduction. Data from this survey could be useful to health care professionals and developers of AP systems.

Utility of bedside artificial pancreas for postoperative glycemic control in cardiac surgery.

Perioperative hyperglycemia, hypoglycemia, and high glycemic variability are independent risk factors for mortality in critically ill patients. After cardiac surgery, intensive glycemic control without hypoglycemia may help to reduce the number of adverse events; however, postoperative glycemic control is difficult in many cases. In this study, we investigated whether the bedside artificial pancreas STG-55 is useful for postoperative glycemic control in cardiac surgery. METHODS: In the present single-center retrospective study, we analyzed arterial blood glucose levels for 15 h after surgery in 69 patients treated using the bedside artificial pancreas and in 160 patients treated with continuous intravenous insulin infusion using a scale that adjusts for current blood glucose level, glycemic fluctuation, and insulin dose. RESULTS: Hypoglycemia (arterial blood glucose level < 70 mg/dL) was not observed in any case. Patients in the group treated using the bedside artificial pancreas showed lower mean, maximum, and minimum blood glucose levels and glycemic variability and shorter treatment duration in the intensive care unit than patients treated with continuous intravenous insulin infusion. Notably, these results were not affected by diabetes status or differences in operative procedures. Analysis of patients undergoing isolated coronary artery bypass grafting surgery revealed that the incidence of surgical site complications composite with infection and dehiscence was lower. CONCLUSIONS: In cardiac surgery, postoperative treatment using bedside artificial pancreas is a novel therapy that improves hyperglycemia and glycemic variability, without hypoglycemia, and is, therefore, an attractive strategy for future surgeries.

Efficacy, safety, and user experience of DIY or open-source artificial pancreas systems: a systematic review.

The do-it-yourself artificial pancreas system (DIYAPS) is a patient-driven initiative with the potential to revolutionise diabetes management, automating insulin delivery with existing pumps and CGM combined with open-source algorithms. Given the considerable interest in this topic within the diabetes community, we have conducted a systematic review of DIYAPS efficacy, safety, and user experience. Following recognised procedures and reporting standards, we identified 10 eligible publications of 730 participants within the peer-reviewed literature. Overall, studies reported improvements in time in range, HbA1c (glycated haemoglobin), reduced hypoglycaemia, and improved quality of life with DIYAPS use. While results were positive, the identified studies were small, and the majority were observational and at high risk of bias. Further research including well-designed randomised trials comparing DIYAPS with appropriate comparators is recommended.

Using a Do-It-Yourself Artificial Pancreas: Perspectives from Patients and Diabetes Providers.

BACKGROUND: A growing number of people with diabetes are choosing to adopt do-it-yourself artificial pancreas system (DIYAPS) despite a lack of approval from the US Food and Drug Administration.We describe patients' experiences using DIYAPS, and patient and diabetes providers' perspectives on the use of such technology. METHODS: We distributed surveys to patients and diabetes providers to assess each group's perspectives on the use of DIYAPS. The patient survey also assessed glycemic control and impact on sleep. The patient survey was distributed in February 2019 via Facebook and Twitter (n = 101). The provider survey was distributed via the American Association of Diabetes Educators' e-mail newsletter in April 2019 and the Pediatric Endocrine Society membership e-mail list in May 2019 (n = 152). RESULTS: Patients overwhelmingly described improvements in glycemic control and sleep quality: 94% reported improvement in time in range, and 64% reported improvement in all five areas assessed. Eighty-nine percent of patients described DIYAPS as "Safe" or "Very Safe," compared to only 27% of providers. Most felt encouraged by their diabetes provider to continue using DIYAPS, but few described providers as knowledgeable regarding its use. Providers cited a lack of experience with such systems and an inability to troubleshoot them as their most significant challenges. CONCLUSIONS: Despite evidence that DIYAPS usage is increasing, our surveys suggest that patients' adoption of this technology and trust in it is outpacing that of diabetes providers. Providers must be aware of this growing population of patients and familiarize themselves with DIYAPS to support patients using this technology.

Do-It-Yourself (DIY) Systems in Diabetes: A Family and Provider Perspective.

Type 1 diabetes is a unique disorder, requiring constant and vigilant assessment of glucose levels, food/snacks consumed, activities and exercise, emotions and stress, hormonal influence, and illness. No other diagnosis is as intensive in terms of the "burden" of care that impacts the patient/family physiologically, cognitively, and psychologically. Several Do-It-Yourself (DIY) closed-loop systems currently exist and can provide options for patients and families looking to reduce the burden of type 1 diabetes. However, as the systems are not Food and Drug Administration approved, healthcare providers are faced with the decision of whether to support patients using DIY systems. This manuscript discusses the ethics of choice and patient autonomy from the perspective of patient/family and healthcare provider. A set of proposed guidelines for healthcare providers are also presented for consideration when interacting with a patient or family who desires to use a DIY system to help manage type 1 diabetes.

A Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas for Type 1 Diabetes: A Randomized Controlled Crossover Trial.

OBJECTIVE: The rapid insulin-alone artificial pancreas improves glycemia in type 1 diabetes but daytime control remains suboptimal. We propose two novel dual-hormone artificial pancreas systems. RESEARCH DESIGN AND METHODS: We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes. Participants were assigned to the interventions in random order during three 24-h inpatient visits. Each visit was preceded by an outpatient hormonal open-loop run-in period of 10-14 days. The dual-hormone artificial pancreas delivered pramlintide in a basal-bolus manner, using a novel dosing algorithm, with a fixed ratio relative to insulin. The primary outcome was time in the range 3.9-10.0 mmol/L. RESULTS: Compared with the rapid insulin-alone artificial pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18%) to 84% (13%) (P = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19%]; P = 0.22). The increased time in range with the rapid insulin-and-pramlintide system was due to improved daytime control (daytime time in range increased from 63% [23%] to 78% [16%], P = 0.0004). There were 11 (1 per 2.5 days) hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) with the rapid insulin-alone system, compared with 12 (1 per 2.3 days) and 18 (1 per 1.4 days) with the rapid and regular insulin-and-pramlintide systems, respectively. Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe. CONCLUSIONS: A novel rapid insulin-and-pramlintide artificial pancreas improves glucose control compared with a rapid insulin-alone artificial pancreas (ClinicalTrials.gov number NCT02814123).

Do-It-Yourself Artificial Pancreas Systems: A Review of the Emerging Evidence and Insights for Healthcare Professionals.

Application of artificial pancreas systems in type 1 diabetes (T1D) represents a change in approach to managing complex glucose and insulin dynamics using automated features with higher levels of safety, precision, and reliability than those afforded by manual adjustments. To date, limited commercial systems and more widely used open-source, hybrid closed loop, Do-It-Yourself Artificial Pancreas Systems (DIY APS) have been used in nontrial real-world management of T1D. The aims of this article are twofold. First, itsynthesizes the emerging literature on DIY APS and identifies a range of evidence including research, reviews, commentaries, and opinion pieces written by DIY APS users, healthcare professionals (HCPs), and researchers. It summarizes the emerging clinical evidence for DIY APS and provide insight into how the DIY APS movement began, has been disseminated throughout diabetes online communities, and is reshaping self-management of T1D in real-world settings. Second, the article provides commentaries that explore implications of DIY APS to healthcare practice. DIY APS are radically changing T1D management. Automating the process of frequently analyzing glucose readings and appropriately titrating insulin delivery is liberating people with T1D (PWD) from some of the demands of intensive management. Within this super-specialized area of T1D management, the expertise of DIY APS users has outstripped that of many HCPs. While educational, ethical, and legal constraints need to be resolved, HCPs still need to stay abreast of this rapidly developing area. Further research is needed to inform policy and practice relating to DIY APS. Meanwhile, HCPs continue to learn from PWD's real-world experiences of building and using DIY APS to improve metabolic and psychological outcomes.

Do-It-Yourself (DIY) Closed Loop Systems: Perspectives of an Endocrinologist.

Do-It-Yourself closed loop systems are becoming increasingly popular as an alternative choice for managing type 1 diabetes. In this commentary, the issues that are faced by both the clinician and the person with diabetes are discussed from my perspective.

"Do It Yourself" (DIY)-Automated Insulin Delivery (AID) Systems: Current Status From a German Point of View.

A group of dedicated people with a high affinity for technology and good understanding of how to treat their type 1 diabetes have developed systems that enable automated insulin delivery (AID). These persons build these AID systems only for themselves (do it yourself [DIY]) and the quality of glucose control achieved with DIY AID systems is impressively good. This overview presents the current status of this development from a German point of view. A high degree of efforts is required to start and maintain this type of therapy and the user must always remain aware of what she/he is doing in everyday life. One main obstacle is liability, because the medicinal products used by persons with diabetes for DIY AID systems are not approved for this indication. They must be regarded as experimental systems. As long as persons with diabetes build and use these systems for themselves and not for other people, they act at their own risk. If a person with diabetes expresses interest in such a system or is already using it, the diabetologist should inform him about the improper use of the medical devices and about the associated risks. The physician should document this information accordingly.

Health Care Provider Knowledge and Perceptions of FDA-Approved and Do-It-Yourself Automated Insulin Delivery.

BACKGROUND: Automated insulin delivery (AID) technology may reduce variability in blood glucose, resulting in lower risk for hypoglycemia and associated complications, and by extension improve quality of life. While clinical trials, research, and patient experience have consistently demonstrated the value of AID, this technology is still inaccessible to many patients. Patient-driven innovation has resulted in alternative do-it-yourself (DIY) solutions to available off-the-shelf AID devices. METHOD: This two-phase cross-sectional observational study addressed health care provider (HCP) perceptions of AID as well as the perceived need for, development of, and evaluation of an AID fact sheet comparing the most commonly used Federal Drug Administration approved AID and DIY AID devices. RESULTS: Negative attitudes toward the use of DIY AID were low. The majority of HCPs saw their lack of knowledge about how DIY AID work to be the greatest barrier to answering patient questions about what is available (74.4%). Additionally, the majority of HCPs (64.5%) indicated they were either "likely" or "very likely" to use the fact sheet when answering patient questions about AID options. CONCLUSION: Increased awareness and utilization of AID technology offer hope to further reduce the burden of diabetes, but there is a need to bridge the knowledge gap about DIY AID. A fact sheet provides a way to facilitate discussions of this emerging technology between HCPs and patients. Next steps could investigate additional ways to put needed information in the hands of HCPs.

Do-It-Yourself Automated Insulin Delivery: A Leading Example of the Democratization of Medicine.

Digital innovations have led to an explosion of data in healthcare, driving processes of democratization and foreshadowing the end of the paternalistic era of medicine and the inception of a new epoch characterized by patient-centered care. We illustrate that the "do it yourself" (DIY) automated insulin delivery (AID) innovation of diabetes is a leading example of democratization of medicine as evidenced by its application to the three pillars of democratization in healthcare (intelligent computing; sharing of information; and privacy, security, and safety) outlined by Stanford but also within a broader context of democratization. The heuristic algorithms integral to DIY AID have been developed and refined by human intelligence and demonstrate intelligent computing. We deliver examples of research in artificial pancreas technology which actively pursues the use of machine learning representative of artificial intelligence (AI) and also explore alternate approaches to AI within the DIY AID example. Sharing of information symbolizes the core philosophy behind the success of the DIY AID evolution. We examine data sharing for algorithm development and refinement, for sharing of the open-source algorithm codes online, for peer to peer support, and sharing with medical and scientific communities. Do it yourself AID systems have no regulatory approval raising safety concerns as well as medico-legal and ethical implications for healthcare professionals. Other privacy and security factors are also discussed. Democratization of healthcare promises better health access for all and we recognize the limitations of DIY AID as it exists presently, however, we believe it has great potential.

Peer Mentoring in the Do-it-Yourself Artificial Pancreas System Community.

BACKGROUND: The do-it-yourself (DIY) artificial pancreas system (APS) community is led by people with diabetes (PWD) and their families. In contrast to standard models of care, in which health care professionals are responsible for the education and training of PWD and their families, within the DIY APS, community users are reliant on their peers for education and training. The provision of this support has not previously been studied. This article focuses on the role of mentors within the DIY APS community. METHOD: Semistructured interviews were conducted with mentors (n = 9) who were identified with assistance from the DIY APS community. Thematic analysis was undertaken. Results were presented to select participants who endorsed the results as an accurate description of mentoring in the DIY APS community. RESULTS: Mentors' primary motivation was altruism. An empathetic, process-focused approach was modeled by prominent mentors. The use of online forums as the primary source of user support was perceived to be an effective method for sharing the workload. Key challenges for mentors included the frequency with which users asked questions that were answered in the existing documentation, dealing with conflict and managing workload. Most participants did not perceive mentoring to be risky, but did take steps to ensure that users were taking responsibility for their own systems. CONCLUSION: This study is the first to examine the role of mentors within the DIY APS community and also within the broader diabetes online community. Future research might seek to quantify the empathetic, process-focused approach to mentoring.