Return to Parkview Dashboard Blog Share Print. What is an insulin pump? The first insulin pumps were developed in the s. Over time, they have become more discreet. What does it do? What are the benefits of an insulin pump?

There are a number of benefits derived from insulin pumps. The pump, and hence, the insulin, is always attached to the body. This eliminates the need to walk to the refrigerator or another room to grab an insulin pen for injections. No daily injections, just a site change every three days.

The pump can deliver tiny doses of insulin, which is very useful for small children and babies. The pump can deliver a different amount of background insulin at different times of the day and night, which can keep the blood glucose levels more stable than we see with injected long-acting insulin.

The pump can communicate with a continuous glucose monitoring system. The pump, together with a glucose sensor and an appropriate closed loop algorithm, is the closest we can get to an artificial pancreas. Creating a glucose set point setting a target glucose level.

Actively managing insulin delivery to maintain the blood glucose around this set point. The pump can increase insulin delivery on its own if the blood glucose is rising above target and reduce the insulin if the blood glucose is trending toward a low.

What should caregivers consider when choosing an insulin pump for their child? What expectations should caregivers have? Expect life with diabetes to be better! The child will wake up with perfect blood glucose levels every day, less to no severe lows, shorter durations of highs, and greater time with blood glucose levels within the target range Better sleep for the pump user and the caregivers Lower burden of care — no injections, and greater margin of error with carbohydrate counting accuracy Be prepared to troubleshoot high blood glucose readings Be prepared to manage ketones Be prepared to go back onto injections temporarily to fix high blood glucose levels with ketones How much time and effort does a pump require?

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Initial acquisition and total annual costs are high for pump therapy compared with MDI [ 80 ]. These can function independently or can be integrated into pumps to calculate the accurate insulin dose by incorporating expected carbohydrate intake, measured blood glucose values, and previous insulin doses [ 81 ].

Carbohydrate counting using bolus calculator apps has been found to improve glycemic control in MDI-treated diabetes patients [ 82 ]. Diabetes: M, mySugr Roche , and PredictBGL are some of the most used bolus calculator apps.

Bolus wizards are built-in automated bolus calculators specific to insulin pumps for insulin dose recommendations. The use of bolus wizards has been associated with better glycemic control and treatment satisfaction [ 83 ].

The Endocrine Society Clinical Practice Guidelines have strongly encouraged patients to use suitably adjusted built-in bolus calculators in CSII to enhance glycemic control [ 52 ]. Since the conception of CSII, the prime motive has been to design an artificial pancreas that mimics exquisite sugar control with minimal human interference.

Generally, AP links three devices: 1 a sensor like CGM that measures BG and sends data to a computer algorithm, 2 a control algorithm to analyze the data and calculate the required insulin dose, and 3 an insulin infusion pump to deliver insulin as per the computer instructions [ 84 ].

MiniMed G with an Enlite sensor has been recognized as a first-generation artificial pancreas device system with Threshold Suspend automation. Medtronic introduced the MiniMed G system in , taking one step closer to the artificial pancreas system.

This system has integrated smart features such as active insulin tracking, a bolus progress bar, and predictive battery life [ 79 , 85 ]. Recent studies suggested that sensor-augmented pump therapy with the predictive low-glucose suspension algorithm SAPT-PLGM leads to a potential reduction in the metrics of hypoglycemia and post-exercise nocturnal hypoglycemia compared with SAP therapy alone [ 87 , 88 , 89 ].

In , the first hybrid closed-loop system, the MiniMed G insulin pump with a Guardian 3 sensor, was licensed by the FDA for T1D therapy of children 7 years and older. When in auto mode, it functions as a hybrid closed-loop system that automatically controls basal insulin delivery every 5 min based on the CGM values to hold BG levels tightly to the specific target [ 8 ].

These systems have been reported to improve glycemic targets [BG, HbA1c, time-in-range TIR ] and reduce the incidence of nocturnal hypoglycemia to ensure better safety, treatment satisfaction, sleep quality, and cognition in T1D patients [ 88 , 90 , 91 ]. This has been recognized as the only insulin pump certified for cyber and information security.

This system is expected to be expanded as the Omnipod Horizon hybrid closed-loop system in the near future [ 92 ]. A study by Benhamou et al. reported that the use of the DBLG1 system was associated with an increase in TIR Procedures required for the FDA clearance and commercial rollout of this system are on track [ 93 , 94 ].

In , Medtronic started the clinical trials on the MiniMed G system, which has novel features including automatic correction boluses, Bluetooth connectivity, and remote software updates. Another recent technology in this area has been the emergence of alternate controller-enabled ACE infusion pumps.

Unlike the conventional stand-alone pumps, ACE pumps can be interoperable: used jointly with different components of diabetes technologies, permitting custom-made diabetes management for patients according to individual device preferences.

The ACE insulin pump can be combined with automated insulin dosing AID systems, CGMs, BG meters, and other electronics. The FDA authorized the first interoperable t:Slim X2 insulin pump in for subcutaneous insulin delivery for children and adults with diabetes [ 96 ].

In , the FDA approved a new-generation, interoperable, control-IQ artificial pancreas system tandem diabetes. A clinical trial that reported that the use of the control-IQ AP system was associated with a greater percentage of TIR, over the use of SAP, paved way for this approval [ 91 ].

The slow pace of innovations and highly unaffordable cost have been considered the major limitations of these technologies. The emergence of closed-loop systems has been a breakthrough development in diabetes treatment. However, the clinical trials and regulatory procedures mandatory for the commercialization of the AP systems are very complex and time-consuming.

This event marked the beginning of the DIY-APS movement. There are three types of DIY-APS: OpenAPS, AndroidAPS, and Loop. The diabetes community shared DIY diabetes device-related projects on digital and social media platforms such as Facebook, Twitter, NightScout, and GitHub, which led to the convergence of these projects.

In , Dana Lewis, Scott Leibrand, and Ben West launched the OpenAPS project, the first DIY-APS that provided the instructions and outline of a DIY patient-built APS [ 99 ]. DIY-APS uses individually made unauthorized algorithms to convert CGM data and calculate insulin doses, FDA approved communication devices, and insulin pumps.

Since it involves the use of unauthorized algorithms, these systems are not FDA approved, commercialized, or regularized. It is a translator device that enables easy communication between the insulin pump and iPhone. This device is considered more user-friendly, and it is easy to set up and to maintain the procedures [ ].

Real-life experiences from patients and caregivers, anecdotal data, and published reports from selected cohorts have highlighted the clinal benefits and reductions in self-management burden with DIY-APS [ ]. Edward Damiano in In this system, automated dosing assessments of insulin and glucagon levels are made every 5 min based on the appraised CGM data.

These data are transmitted to pumps to regulate insulin or glucagon delivery [ ]. Previous studies in home-use and outpatient settings indicated better glycemic regulation and positive psychosocial impacts associated with the use of the bionic pancreas [ , ]. Another study noted that the insulin-only mode of the iLet significantly increased TIR in adults with type 1 diabetes to Ekhlaspour et al.

Making use of their first-hand experiences with the triumphs and challenges of diabetes management, many D-Dads, parents of children with diabetes, have become the flagbearers of patient-led innovations and movements in the arena.

The credit for the invention of the bionic pancreas goes to Dr. Edward R. Damiano, a professor of biomedical engineering at Boston University.

He designed a BP to achieve automation for constant monitoring and adjustments of BG levels for his son, David, who was diagnosed with T1D at 11 months.

He is the founder and CEO of the Beta Bionics firm, conducting research trials on iLet BP [ ]. Pete Schwamb, a software engineer, made path-breaking contributions in the field of diabetes technologies.

Being a hacker by profession, he has been recognized as a standard-bearer for the DIY-APS hacking mission [ ]. Nightscout CGM in the Cloud was co-developed by Lane Desborough, D-Dad of Hayden. He was a chief engineer at Medtronic and was one of the advocates of the WeAreNotWaiting movement.

Lane was the first person to get involved in the DIY-APS movement from the industry and later co-founded Bigfoot Biomedical [ ]. Howard Look and Steve McCanne are D-Dads to their respective daughters with T1D and pursuing a vision to bring about innovations to reduce the management burden of T1D through their cofounded non-profit organization, Tidepool.

Tidepool is currently on a venture to release a regulated version of the DIY-APS in collaboration with Omnipod and Dexcom [ , ]. The implanted artificial pancreas, a fully implantable insulin delivery device, is another novel AP technology under development at De Montfort University. It is a gel-based system that responds to BG variation by altering the insulin delivery rate.

The performance of this system in glycemic control is well tested in a diabetic domestic pig [ ]. Regardless of category, the goal of the AP system is to improve glycemic outcomes with less hypoglycemia.

It reduces hourly management and human interference to enhance user acceptance and quality of life in diabetes patients. The next step of AP would be exploiting engineering integration and validating the prototype systems with subsequent studies in large outpatient settings [ ].

Insulin inhalers allow patients to breathe in fine-inhalable insulin pulmonary insulin either dry powder-based formulations or solution into their lungs. The pulmonary route of insulin administration was closer to physiologic portal delivery and therefore the first substitute for the subcutaneous route of insulin delivery [ 16 ].

When introduced to the market in , inhalable insulin was considered a significant innovation to address needle phobia and incorrect insulin injection techniques pertained to systemic insulin delivery methods. The effectiveness of inhalable insulin in diabetes treatment, especially for postprandial hyperglycemia, has already been proven [ ].

The first inhalable insulin, Exubera Pfizer , was approved by the FDA in for the treatment of T1D and T2D. However, the use of Exubera was associated with an increased risk of hypoglycemia.

The product was withdrawn from the market in because of its high cost and dose inaccuracy [ , ]. The only surviving candidate in this category is Afrezza, a rapid-acting Technosphere insulin powder MannKind Corp. Afrezza got FDA approval for prandial insulin therapy in [ ].

The delivery system of Afrezza is small, handy, and displays the dose in units [ ]. The use of Afrezza has provided significant glycemic control and reduction of hypoglycemia in T1D patients [ , ].

The acceptance of inhalable insulins is further limited by insurance barriers, safety concerns, and competing products [ ]. Another possible entrant to the market could be jet injectors, a type of syringe that dispenses insulin subcutaneously with the aid of a high-pressure air mechanism. Pioneer jet injector technology was introduced in the s.

In , the Ped-O-Jet was discontinued as a result of contamination issues raised with the use of MUNJI [ ]. The new-generation, disposable-syringe jet injectors DSJIs with disposable dose chambers insulin cartridge and nozzles were launched in the s. Even though the idea is not first hand to the market, the wider acceptance of these devices has been stalled by the cost, low absorption with the repeated use, and high contamination rates of the previous systems [ ].

Needless to say, the jet injectors are a solution for patients with needle phobia [ ]. Recent safety and feasibility studies have evaluated the treatment efficiency and pharmacokinetic and pharmacodynamic PK-PD profiles of the insulin administered by the new-generation jet injectors [ , ].

In the past decade, there has been a high-speed evolution in diabetes technologies to improve the quality of life and to extend the longevity of subjects with diabetes. Though there were commendable developments in the currently available devices, many of those were prohibitively expensive.

In addition, there were serious issues associated with cannula blockages, infusion set handling, Bluetooth connectivity, and user-friendliness.

Some of the promising experiences are shared by subjects using DIY-APS. The DIY revolution has prompted all the device manufacturers to introduce ACE pumps and compatible sensors. Although the mission demands enormous commitment and time, it has the potential to transform diabetes therapy.

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