Technologies in the management of type 1 diabetes
Authors: Jennifer R Snaith and D Jane Holmes‐Walker
Published online: 1 March 2021
Technology is changing the way that people with type 1 diabetes are monitoring and managing their blood glucose levels
Diabetes technologies have transformed management options in type 1 diabetes. The most notable innovations include the commercialisation of insulin pumps, advancements in glucose monitoring and the capacity for these technologies to interact. New technologies offer enhanced flexibility in insulin delivery and opportunities to improve glucose levels and enhance quality of life. Recognising these benefits, the uptake of advanced technologies in Australians with type 1 diabetes has increased. In 2018–2019, 41% of children and 26% of adults attending hospital diabetes clinics managed their type 1 diabetes with insulin pumps, and 55% of children and 13% of adults newly commenced continuous glucose monitoring (CGM).1 In this article, we provide a guide to current diabetes technologies available in Australia, describe their benefits and discuss important factors in assessing an individual’s suitability.
Continuous glucose monitoring
Accurate and accessible glucose monitoring is key to effective diabetes management. Finger‐prick testing of capillary blood for self‐monitoring of blood glucose (SMBG) became commercially available in the 1980s, and CGM since 1999. CGM is distinguished from SMBG by the measurement of glucose concentration within interstitial fluid by a small subcutaneous glucose‐sensing electrode. Data are transmitted to a receiving device (eg, insulin pump or smartphone) and converted into a continuous graphic display. Interstitial glucose concentrations correlate with plasma glucose, albeit with an average 7–8 minute time lag for equilibration of glucose between blood and the interstitial compartment. This delay is exaggerated at times of rapidly changing glucose.
CGM systems come in different forms, with the main distinguishing features being the capacity to alert users and/or carers to high and/or low blood glucose levels set to individual preference. Various systems are available (Box 1).2,3 Product selection depends on the desirability of alarm functions, ease of sensor application, need for finger‐prick calibration, cost, and connectivity of the device to existing technologies (insulin pumps, Apple v Android systems).
Modern CGM systems are reliable. Their performance is assessed by the mean absolute relative difference, an accuracy metric expressed as the percentage difference relative to a reference glucose concentration. CGM devices with a mean absolute relative difference < 10% are appropriate for treatment decisions.2,4 To optimise sensor performance, SMBG testing is still required to calibrate a number of real‐time CGM devices, yet devices are increasingly reliable such that newer factory calibrated devices no longer require user calibrations5 — a welcome feature for convenience and reduced finger‐prick burden.
CGM offers several benefits to users, including on‐demand glucose testing, trend arrows, alarm functions and easy detection of out‐of‐range glucose levels. For clinicians, CGM offers additional data beyond glycated haemoglobin (HbA1c) measurements. HbA1c measurements are point estimates of haemoglobin glycation over 3 months, whereas CGM displays day‐to‐day glucose variability that often challenges people with type 1 diabetes. Consensus statements have attempted to harmonise the various commercially available CGM systems into a common reporting method to aid comparison between devices and also provide clinicians and users with more clinically meaningful data and targets (Box 2).2,6,7
Clinical trials provide evidence that CGM use may improve glycaemia in type 1 diabetes. A recent meta‐analysis of 15 randomised controlled trials comparing CGM with standard care (usually SMBG) in people with either type 1 or type 2 diabetes over 12–36 weeks found that CGM was associated with a slight reduction in HbA1c levels (weighted mean difference, − 0.17%), and increased time in range (TIR; 71 minutes/day).8 Added up over a year the benefit equates to an additional 18 days of TIR. The effect on TIR was independent of diabetes type, or method of insulin delivery (insulin pump v needle injections). Overall, studies favour CGM to improve glucose variability (optimal coefficient of variation in diabetes management, 34%; coefficient of variation reduced by 3.0–6.7%) and reduce hypoglycaemia (0.4–1.2 hours reduction in time spent with glucose levels < 3.9 mmol/L) compared with SMBG.2
The benefits of CGM and flash glucose monitoring for type 1 diabetes management have been recognised by the Australian Government, which first pledged $54 million in 2016 to fully subsidise CGM in people under 21 years of age. In 2019, a further $100 million in subsidies was added. Eligibility criteria were again expanded in March 2020 (Box 3).9
Insulin pumps
An insulin pump delivers short‐acting insulin continuously via a cannula self‐inserted into subcutaneous tissue. In the 1970s, the first insulin pumps were large and bulky and delivered a single basal rate of insulin. Modern pumps are more discrete, the size of a pager.
An insulin pump set‐up includes two major components (Box 4):
- Insulin pump — case with display, battery and an insulin reservoir connected to a plunger that controls the passage of insulin into the line tubing. The insulin pump is programmed to deliver continuous quick‐acting insulin in equal aliquots (0.01–0.025 mL) across an hour depending on the pre‐set rate to replicate basal insulin. Programmed rates can be customised to vary across a 24‐hour period, distinguishing delivery from long‐acting insulin delivered at an inflexible basal rate. The user must initiate bolus doses for meals or for correction of an elevated glucose reading, but pre‐programmed settings provide dose calculations (insulin‐to-carbohydrate ratio for meals, and insulin sensitivity factor for correction doses).
- Line tubing and infusion set — up to 60 cm of thin plastic tubing connects the insulin reservoir to a subcutaneous teflon cannula (tubeless insulin patch pumps with variable hourly rates are not currently available in Australia).
- Potential benefits of insulin pumps include:
- ► Flexibility in dosing — useful for extreme insulin sensitivity, erratic schedules, more convenient and frequent bolusing, to accommodate exercise, or to manage the dawn phenomenon (increased insulin requirements in the early morning period due to counter‐regulatory hormone secretion).
- ► Bolus calculation capacity.
- ► Less frequent insertion events (about every 3 days) — favourable for individuals with needle phobia.
- ► Insulin delivery and glucose data can be generated electronically and remotely for review.
As only quick‐acting insulin is used in insulin pumps, insulin deficiency (leading to possible diabetic ketoacidosis) may occur within 2–3 hours of discontinuation of the insulin pump, or in the event of set occlusion. Set occlusion is one of the leading causes of ketoacidosis in insulin pump‐treated individuals but is rapidly corrected with recommencement of insulin in the absence of intercurrent infection (Box 5). However, insulin pump use has not resulted in the increased diabetic ketoacidosis events anticipated when first introduced, aided by appropriate education.10
There are out‐of‐pocket costs, especially for individuals without private health insurance, and running costs are higher than with insulin injection. Wearing an externally attached device to the body 24 hours a day is a deterrent to some, but a convenience for others who dislike carrying needle tips and insulin pens.
Insulin pumps can be used either as a stand‐alone device or in conjunction with CGM sensors (Box 6). Sensor‐augmented insulin pumps have the added benefits of suspended insulin delivery for predicted low glucose (predictive low glucose suspend), or at the threshold of hypoglycaemia (low glucose suspend) to reduce the frequency and duration of hypoglycaemia. In a study of individuals with documented nocturnal hypoglycaemia, those randomised to insulin pumps with low glucose suspend function for 3 months had 32% less frequent hypoglycaemia than without suspend function.11 Other trials have also demonstrated reduced time in hypoglycaemia without increase in time in hyperglycaemia.12
The latest insulin pump systems (hybrid closed loop; HCL) can provide a further degree of automation of insulin delivery. HCL pumps provide real‐time adjustment of insulin delivery in response to ambient glucose levels detected by a CGM sensor, via an inbuilt control algorithm. The user is still required to manually deliver boluses for meals or adjust insulin for exercise. A recent study comparing HCL to sensor‐augmented insulin pump therapy reported improved TIR during daytime hours as well as overnight, and a small reduction in time in hypoglycaemia over 6 months.13 There is currently only one registered HCL insulin pump in Australia. Future technologies may provide further integration of CGM and insulin pump devices via phone‐based applications.
Tailoring treatments to individual needs
The optimal approach for the management of type 1 diabetes depends on individual and practical considerations. Initiation of insulin pump therapy requires extended consultation to discuss device selection and cannula insertion technique, and review carbohydrate counting and troubleshooting (including diabetic ketoacidosis risk mitigation). It also requires a multidisciplinary approach involving an endocrinologist, credentialled diabetes educator and dietitian.14 In concert with the individual with diabetes, factors to discuss include:
- the need for alerts and alarms: presence of hypoglycaemia unawareness and susceptibility to alarm fatigue;
- affordability and eligibility for CGM supplied under the National Diabetes Services Scheme (Box 3);
- access to training and education;
- customisation of glucose targets for pregnancy, age and comorbidities;
- ability to use software to upload data and share reports with health professionals; and
- allergies to cannula or CGM site adhesives.
Conclusion
Diabetes technologies are being increasingly adopted by people with type 1 diabetes, and clinicians should familiarise themselves with the spectrum of devices. These advancements offer potential benefits for people with diabetes, although prescribing these devices requires evaluation of cost and benefit for the individual. Human factors are the main determinant of success and satisfaction, highlighting the importance of consideration of the needs of the individual.
Box 1 – Types of continuous glucose monitoring (CGM) systems2,3
- Professional (retrospective): professional CGMs were the first CGM systems approved by the United States Food and Drug Administration in 1999. They provide blinded glucose data for review by a health care provider. The iPro (Medtronic) and Freestyle Libre Pro (Abbott) are currently available systems in Australia.
- Real‐time CGM: patient‐inserted systems include Guardian (Medtronic), Guardian Connect (Medtronic) and G6 (Dexcom). The Eversense (Senseonics) CGM implantable system is inserted subcutaneously by a physician and worn for 90–180 days with a transmitter adherent to the overlying skin with alert capacity (not currently available in Australia).
- Intermittently viewed CGM or flash glucose monitoring: Freestyle Libre for continuous glucose measurements shown retrospectively at the time of physical scanning of the sensor does not have alert capacity. Freestyle Libre 2 will have optional alerts but is not yet available in Australia.
Box 2 – Internationally accepted continuous glucose monitoring (CGM) metrics for clinical use and comparison between devices (adapted from guidelines)2,6,7
- Percentage sensor wear and data captured — to gauge completeness of data capture (optimal wear time assessed as > 70% capture across a 14‐day time period)
- Mean glucose — the sum of all glucose levels, divided by number of measurements; a surrogate of overall glucose control, with reasonable correlation with glycated haemoglobin
- Glucose variability — standard deviation of glucose/mean glucose × 100 = coefficient of variation (CV); goal is CV < 36% in type 1 diabetes
- Time in range (3.9–10.0 mmol/L) — aim > 70%; the ranges can be tailored to the individual depending on their age and comorbidities (eg, older individuals or pregnancy) and provide an estimate of level of current glycaemic control otherwise not reflected in a glycated haemoglobin measurement
- Time in hypoglycaemia:
- ► < 3.9 mmol/L — goal < 4% (includes proportion values < 3.0 mmol/L)
- ► < 3.0 mmol/L — goal < 1%
- ► number of CGM events < 3.0 mmol/L for 15 minutes or more in previous 2 weeks — focuses on the importance of moderate hypoglycaemia
- Time in hyperglycaemia:
- ► 10 mmol/L — goal < 25% (including time > 13.9 mmol/L)
- ► 13.9 mmol/L — goal < 5%.
- Other reportable data (from insulin pump downloads):
- ► total daily insulin, % basal — a summary of current total insulin delivery, split into dose delivered as basal and bolus insulin; this allows for comparison between visits
Box 3 – Access to subsidised continuous glucose monitoring (CGM) through the National Diabetes Services Scheme (NDSS)*9
The following groups can access CGM or flash glucose monitoring through the NDSS:
- Children and young people under 21 years of age with type 1 diabetes
- Children and young people with conditions very similar to type 1 diabetes, such as cystic fibrosis‐related diabetes or forms of genetic diabetes (including maturity onset diabetes of the young), who require insulin
- Women with type 1 diabetes who are actively planning pregnancy (up to 12 months before conception), pregnant or immediately post‐pregnancy (pregnancy plus 3 months from expected date of confinement)
- People with type 1 diabetes aged 21 years or older who have concessional status
*Criteria valid from 1 March 2020.
Box 5 – Steps in managing ketosis caused by insulin pump line occlusion (in the absence of vomiting)
- Insulin pen injection using pump‐advised correction dose for high blood glucose
- Replace insulin pump cannula set
- Run increased basal insulin rates (200%) temporarily for 2 hours to restore subcutaneous insulin reservoir and missed insulin
- At 2 hours, deliver correction insulin dose with insulin pump
- Monitor blood ketones every 3–4 hours using a ketone meter to ensure ketone levels < 1.5 mmol/L
Competing interests
No relevant disclosures.
References
- Australasian Diabetes Data Network. Research: demographic and clinical characteristics of adult participants, https://www.addn.org.au/research (viewed May 2020).
- Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care 2017; 40: 1631–1640.
- Hirsch IB, Battelino T, Peters AL, et al. Role of continuous glucose monitoring in diabetes treatment. Arlington, VA: American Diabetes Association, 2018. https://professional.diabetes.org/sites/professional.diabetes.org/files/media/final_ada-abbott_cgm_compendium_final.pdf (viewed May 2020).
- Martin CT, Criego AB, Carlson AL, Bergenstal RM. Advanced technology in the management of diabetes: which comes first — continuous glucose monitor or insulin pump? Curr Diab Rep 2019; 19: 50.
- Hoss U, Budiman ES. Factory‐calibrated continuous glucose sensors: the science behind the technology. Diabetes Technol Ther 2017; 19: S44–S50.
- Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care 2019; 42: 1593–1603.
- Twigg S, Cohen N, Wischer N, Andrikopoulos S. Consensus position statement on: utilising the Ambulatory Glucose Profile (AGP) combined with the Glucose Pattern Summary to support clinical decision making in diabetes care. Sydney: Australian Diabetes Scoiety, 2020, https://diabetessociety.com.au/documents/ADSAGPConsensusStatement29022020-FINAL_000.pdf (viewed May 2020).
- Maiorino MI, Signoriello S, Maio A, et al. Effects of continuous glucose monitoring on metrics of glycemic control in diabetes: a systematic review with meta‐analysis of randomized controlled trials. Diab Care 2020; 43: 1146–1156.
- National Diabetes Services Scheme. Continuous and flash glucose monitoring. https://www.ndss.com.au/living-with-diabetes/managing-diabetes/continuous-glucose-monitoring/ (viewed May 2020).
- Pickup JC. Insulin‐pump therapy for type 1 diabetes mellitus. N Engl J Med 2012; 366: 1616–1624.
- Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold‐based insulin‐pump interruption for reduction of hypoglycemia. N Engl J Med 2013; 369: 224–232.
- Forlenza GP, Li Z, Buckingham BA, et al. Predictive low‐glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at‐home randomized crossover study: results of the PROLOG trial. Diab Care 2018; 41: 2155–2161.
- Brown SA, Kovatchev BP, Raghinaru D, et al. Six‐month randomized, multicenter trial of closed‐loop control in type 1 diabetes. N Engl J Med 2019; 381: 1707–1717.
- Alcántara‐Aragón V. Improving patient self‐care using diabetes technologies. Ther Adv Endocrinol Metab 2019; 10: 1–11.
Provenance: Commissioned; externally peer reviewed.
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