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• Endocrine Reviews, 2023, 44, 254–280 

https://doi.org/10.1210/endrev/bnac022

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice

ABSTRACT

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. 

While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. 

During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. 

Thus, AID systems have recently become an integral part of diabetes management. 

However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations  are critical  for  AID success  and  acceptance. 

All clinicians  working  with PwD  need  to become  familiar  with the  available systems  in order  to  eliminate disparities  in  diabetes quality  of  care.  

This report  provides  much-needed guidance  for  clinicians who  are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

 

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ESSENTIAL POINTS

• AID therapy increases time in target glucose range with either no increase or a reduction in hypogly-cemia compared with other diabetes therapies; AID therapy should therefore be considered for all popu-lations with type 1 diabetes as it increases the likeli-hood of reaching recommended glycemic targets

• Healthcare providers need to be aware of the differ-ent AID systems available, their benefits, and their limitations, to be able to advise and support people with diabetes to increase the likelihood that the clin-ical benefits of AID are realized

• Commercially available AID systems still require ba-sic diabetes management skills, including carbohy-dratecounting,for  optimal  glycemic control; opportunities  to  review and  refresh  these skills, where needed, should be sought 

• SpecificAIDtraining  and support  for  users and healthcare providers are important to maximize clin-ical benefits of AID therapy

• AID therapy is associated with significant improve-ments in quality of life and reduced burden of dia-betesmanagementfor  people  with diabetes  and their families

• Since clinical outcomes with AID therapy depend on high AID usage, consideration should be given to the usability of available AID systems; optimal AID sys-tems require low user input to achieve excellent gly-cemic outcomes

• There are well documented and multifactorial racial and ethnic disparities in prescribing AID system technologies; healthcare provider preconceptions and unconsciousbiasesabout  individual, family,  and psychological attributes required to use AID technol-ogy effectively should be recognized and mitigated to ensure fair and equitable access to AID systems

Introduction

Diabetes is a chronic, demanding condition that poses a con-stant burden both on people with diabetes and on healthcare systems. 

Only a minority of persons with type 1 diabetes (T1D) meet widely accepted glycemic goals (1), demonstrating that there is an unmet need for better methods to achieve these goals. 

During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies.  Studies with  various  AID systems  unequivocally demonstrate improvement in glycemic outcomes in people with T1D across all age groups, in all genders, and regardless of diabetes duration, prior insulin delivery modality, or base-line glycated hemoglobin (HbA1c) levels (2– 6). 

Studies have also suggested cost-effectiveness of these systems (7–10). 

Yet despite the success of AIDs in improving glycemic control, guidance for integrating AID systems into clinical practice is limited. Moreover, as with all new technologies, negotiating insurance coverage for AID has been protracted.

In 2021, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress organized an international panel of clinicians, researchers, and patient advocates with expertise in AID to develop clinical guidelines for initiating AID for individuals with T1D. The panel was divided into 9 working groups to address the various aspects of AID therapy, including evolution of AID; clinical evidence; determining the target population for AID use; initiation of AID; education and training; utilization of AID; AID data reporting; psychological issues/user perspective; and the future of AID.

Recommendations from each working group were presented to the full panel and voted upon. This article summarizes the consensus recommendations from the panel

Summary of Clinical Evidence

Clinical evidence supporting the efficacy and safety of AID systems has grown over the last 5 years with the introduction of multiple commercially available, and soon to become avail-able, AID systems. As of March 2022, the U.S. Food & Drug Administration (FDA) has approved the Medtronic 670G/ 770G (4,  17,  18), the Control-IQ (2, 19,   20), and recently cleared the first tubeless AID system, the Insulet Omnipod 5 (21).

Conformite Europeenne (CE) approval has been granted to  the Medtronic  780G  (5, 22,  23);  CamAPS  FX (6); Diabeloop (24, 25); Inreda (26); Control-IQ, and Medtronic 670G. Some systems are currently under FDA review, includ-ing the Medtronic 780G (5,  22,  23) and Tidepool Loop (27).

Randomized Controlled Trials

Randomized controlled trials (RCTs) and single-arm studies with interventions of 3 months or longer, including children as young as 2 years and adults up to 75 years of age with T1D have been conducted (Tables 3and 4). 

Some RCTs provide separate analyses for adolescents and adults allowing evaluation in specific age groups. Study designs vary from single-arm trials without a concurrent comparator to parallel-group studies and crossover randomized trials. The lack of a control group in single-arm studies limits the ability to determine how much of this achievement is attributed to AID use, as opposed to a study effect. 

Furthermore, some of the populations studied differ in baseline time in range (TIR; 70–180 mg/dL). Lower baseline TIR was found to be associated with a greater improvement in TIR on AID (33). These differences in study design impair the ability to do cross-study comparisons.

In general, all the AID systems have uniformly demonstrated an increase in TIR and a reduction in mean glucose, time in hyperglycemia, and HbA1c. Overall improvement in glycemic control was similar across all age groups and was evident during both day and night. 

Yet even with AID use, TIR improves more overnight than during the day. TIR increased by 9% to 16% for most systems while HbA1c levels decreased by 0.3% to 0.5%, with either no change or a reduction in time in hypoglycemia. 

The greatest improvement in glycemic control is seen in those who have the lowest baseline TIR or highest HbA1c (33, 34). 

The effect on hypoglycemia has varied, also depending on the comparison group features and the amount of hypoglycemia present at baseline. In some studies, use of AID has been shown to  reduce hypoglycemia  even  when compared  to  sensor- augmented pump (SAP) therapy with predictive low glucose sus-pend (PLGS) (5, 35). 

Of note, AID use resulted in reduced rates of both hypoglycemia and hyperglycemia, thus increasing TIR. This contradicts the paradigm that improving glycemic control necessarily leads to an increase in hypoglycemia (36).

Real-World Studies

Real-world data are now also available, shedding light on true AID acceptance and performance. 

It is reassuring to find that 261outcomes are similar to those of the pivotal studies in the means of TIR and time below range (TBR), with a modest re-duction in HbA1c of 0.3% to 0.4% (35,   37–40). (Table 5). 

Current data also supports improved quality of life and users’ reported outcomes (42–44). 

However, several publications on real-world use of the Medtronic 670G revealed that approxi-mately one-third of youth starting on the 670G system discon-tinue  use  within 1  year  (45,  46).  

Recent studies  showed increased  use of  auto-mode  on Medtronic’s  Advanced Hybrid AID compared to 670G (86% vs 75%, respectively) (23)  and the  real-world  data of  the  use of  Tandem’s Control-IQ which reported 94% use of auto-mode (35).Altogether, the data gathered provide solid evidence for the safety and efficacy of AID system use for a broad age range of PwD. 

Rates of acute complications such as severe hypogly-cemia (SH) and diabetic ketoacidosis (DKA) were low. Of note, almost all pivotal trials exclude (or have very few) par-ticipants with a recent history of DKA or SH, thereby substan-tially lowering the risk of such complications. 

Real-world observational trials show lower rates of DKA/SH than those published in the US T1D Exchange Registry (1). Several studies also suggested improved quality of life, reduced diabetes burden, reduced fear of hypoglycemia and a return to restful sleep for PwD and family (44,  47–53), while few studies failed to find improvements in patient-reported outcomes (43, 54) (see “Psychological  Issues and  PwD  Perspectives on  AID Systems”).

Knowledge Gaps

An analysis of the MiniMed 670G AID system vs continuous  subcutaneous  insulin delivery  (CSII),  showed that the higher acquisition costs of the AID system were offset by clinical benefits, reduced complication costs, and quality of life improvements, which represented an overall cost-effective treatment option for people with T1D (8). 

Similar results were reported for the MiniMed 670G AID system vs multiple daily injections (MDI) and intermittent scanned CGM (isCGM) (10). Additional data on other systems will be valuable.

Another knowledge gap is the use of AID systems in special populations. Data are accumulating on AID use in young chil-dren (< 6 years) with T1D (55–57). Several feasibility studies describe AID use in other populations, such as pregnant wom-en with T1D (58,   59) and people with T2D (60, 61). 

To support AID implementation in these populations, larger and longer randomized controlled studies are needed. In addition, both RCTs and real-world studies lack racial and ethnic diver-sity, thereby limiting universal AID adoption (62)

Summary of recommendations: target populations

• Strongly consider recommending AID systems to all people with T1D to improve glycemic control 

• School-aged children (7–14 years) (2, 3,5,20,   46,   63–67) A• Adolescents/Adults (3, 6,  68) A

• Consider recommending to:
• Older adults (above 65 years) (2, 29,68,69) B

• Preschool children (<7 years) (31, 32,56,57,   70–73) B• People with moderate/severe hypoglycemia and hypoglycemia unawareness (74–77) C

• Pregnancy complicated with T1D (58, 60,78–81) C•

 People with comorbidities: chronic renal failure and gastroparesis (82–84) C

• Consider recommending appropriate AID systems to people with other types of diabetes treated with intensive insulin therapy (multiple daily injections or pump therapy): 
• People with type 2 diabetes (60, 61) C

• People after pancreatectomy E
• People with cystic fibrosis–related diabetes (85, 86) C•

 Use of AID under supervision should be allowed in hospital settings if not contraindicated by clinical status or treatment needs E

Summary

Given the associated improvements in glycemic control and quality of life measures, clinicians should strongly consider use of AID systems in PwD who would benefit from this technological option. 

We recommend that payers support usage of AID systems and other emerging technologies that reduce diabetes  burden  and improve  patient-reported outcomes.  Furthermore, studies  have  suggested long-term cost  saving  for health  care  systems using  these  systems. 

Therefore, we strongly recommend that all payers (government and private) should reimburse/cover AID systems along with initial and ongoing AID education and training to sup-port the management of people with T1D. 

Failure to reim-urse diabetes technologies such as AID systems will deprive many individuals with T1D who would benefit from this valu-able technology and may result in increased disparities in dia-betes outcomes due to racial and social inequities (149,   15)

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https://academic.oup.com/edrv/article/44/2/254/6692818

 

• ADA/EASD konsensus rek kring AID

är också läsvärd, Diabetologia 2023; 66, 3-22

som pdf free utan lösenord, högst läsvärd

https://link.springer.com/article/10.1007/s00125-022-05744-z

Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association

 

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