Recommendations on treatment simplification of complex insulin regimens to improve clinical outcomes in patients with T2DM

Key takeaway

Based on the conclusions from a consensus group meeting (involving expert, multidisciplinary panel), this narrative review provides HCPs with practical recommendations on several areas* for treatment simplification

Treatment simplification^† in patients with T2D, when suitable, eases disease and treatment burden

• Can be achieved^‡with clear guidance, a personalized approach and open communication between HCPs, individuals with T2D and caregivers

• Overall, there is a need to raise awareness on treatment simplification and, change the “mindset” of not modifying treatment plan or considering complex insulin treatments as the best, final option

• Tools and solutions to help HCPs address the unmet need of simplifying complex

  • Telemedicine and virtual consultations

  • Continuous glucose monitoring

  • Use of digital application

  • Patient support programs

Why this matters

T2D, often requires treatment intensification over time to maintain glycemic control and to prevent or delay longterm complications

Treatment intensification represents complex treatment regimen which often is challenging and has:

• Negative impact on QoL

• Difficulties in adherence

Current clinical guidelines are mostly focused on the elderly patients and treatment intensification

• But lack in clear guidance on treatment simplification

Consensus statement by an expert, multidisciplinary panel provided HCPs with practical recommendations on simplifying complex insulin treatment strategies in people with T2D.

Key highlights

Multidisciplinary consensus method for developing recommendations

• Expert multidisciplinary group convened to identify and address the unmet need to simplify T2D treatment
• Literature review conducted on complex insulin treatment simplification
• Considered practical recommendations to simplify unnecessarily complex insulin regimen^§
• 2-day expert consensus group discussion on treatment simplification^¶

Recommendations following the discussions of the consensus group

Terminology

• Number of terms are used interchangeably in the published literature

• It is important to define common terminologies to aid HCP understanding and enable clear peer-to-peer communication with the person receiving treatment

Recommendations

• Simplification is considered the most appropriate terminology to describe reducing the number of insulin injections (including discontinuation) and adapting the treatment strategy to take into account each person’s circumstances
• HCPs should make efforts to use this terminology consistently in conversations with individuals with T2D and/or their carers, as well as other HCPs, to avoid confusion

Current evidence and treatment landscape

• FRCs and premixed insulins can provide an avenue for treatment simplification
• ADA guidelines^# recommend the use of an FRC of basal insulin and a GLP-1 RA, in addition to OADs
• 2^nd generation insulin analog is preferred because of an improved safety profile vs 1st generation analog

Recommendations

• Current clinical guidelines should be developed further to provide clear and specific guidance on simplifying treatment
• They should aid in identifying clinical situations where simplification would be appropriate, and if possible, how it can be achieved

Personalization of t2d care and psychological aspects

• Complex treatment regimen frequently compromises individual QoL

• It is important to consider psychological impact of complex therapy

Recommendations

• HCPs should consider simplification as a means of personalizing therapeutic choices using a shared decision-making approach, decision aids and open communication with individuals and/or caregivers
• Cognitive capabilities and emotional well-being, alongside overall QoL, treatment burden and satisfaction with the current treatment plan should also be evaluated
• PROMs may also provide a useful tool for considering a person’s experience of T2D therapy and estimating treatment burden. Once treatment has commenced, re-assessment and communication should be conducted on an ongoing basis
• These evaluations and discussions should be individualized and occur no less than twice a year. The individual with T2D and their caregivers should be involved in all decision-making and setting of therapeutic goals

Candidates for treatment simplification

• Treatment simplification should be considered for the people with T2D to improve health outcomes or QoL
• There is list of triggers for considering treatment simplification

Recommendations

• Where possible, treatment simplification should be considered for all individuals with T2D receiving a complex insulin therapy regimen

• Triggers for considering simplification should include people who are experiencing poor glycemic control, difficulties with adherence and self-management, severe or frequent hypoglycemic episodes or substantial weight gain
• Individuals with comorbidities, those with cognitive impairments, the frail, those with limited life expectancies, those with a history of falls and instances where current treatment plans negatively impact on QoL should also be considered for simplification

Simplification of complex insulin regimens

• Key consideration when simplifying regimen is safely balancing:
  • Risk of developing long-term complications
  • Symptom burden or severe hyperglycemia
  • QoL and convenience**

Recommendations

• In line with ADA recommendations, treatment modifications should be conducted in a stepwise manner. GLP-1 RAs should be considered an integral part of simplified treatment models
• If OADs, a GLP-1 RA or basal insulin alone have been insufficient in providing adequate glycemic control, a GLP- 1 RA and basal insulin combination should be administered in an FRC or as a free combination

Clinical situations–simplification may be difficult to impliment

• Simplifying treatment may be difficult in some circumstances such as:

  • OADs and non-insulin-based injectable therapies can be contraindicated in certain people or individual may be intolerant to such therapies

Recommendations

• All individuals should be assessed periodically for suitability for treatment simplification. However, in some instances complex insulin regimens may still be the most appropriate form of treatment

  • For such individuals, complex treatment plans need to be followed in line with current clinical guidance and supported by appropriate follow-up

• These individuals should still be regularly reconsidered for simplification and guidelines should be referred to frequently to determine if simplification has become possible for an individual

• Additionally, educational support programs and telehealth services can be utilized to ease the burden of complicated therapy strategies by providing information about self-management

* Confusing terminologies, current evidence and treatment landscape, personalized care and psychological aspects, candidates for treatment simplification, simplification of complex insulin regimens, clinical situation where simplification may be difficult to implement
^† Without compromising therapeutic efficacy and safety
^‡ Although, not always implemented in clinical practice
^§ With the aim of achieving individualized glycemic goals, reducing frequency of hypoglycemia, weight gain prevention and an improvement in QoL
^¶ Evaluated terminology used, current evidence and treatment landscape and personalization of T2D care and psychological aspects
^# When individual require an injectable therapy ** With respect to incorporating the treatment plan into their daily routine

For additional details, refer the source publication (Jude EB, et al.)

MAT-BH-2300284/v1/April2023