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

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