Type 2 diabetes accounts for approximately 90% of diagnosed cases of diabetes in the UK (Diabetes UK, 2012), the total number of which passed 3 million earlier this year and continues to rise (Diabetes UK, 2013). Furthermore, a recent study has shown that 50% of those people with type 2 diabetes are obese (Haslam, 2011). This means there are probably in excess of 1.3 million people in the UK diagnosed with type 2 diabetes and obesity – conditions described, when occurring in combination, as “diabesity”.
Weight loss is considered to be the primary nutritional strategy for managing glucose control in type 2 diabetes for people who are overweight (Diabetes UK, 2011). The past decade has seen the introduction of a number of drug therapies that aim to control blood glucose by treating the complex glucose-regulating mechanisms and promoting weight loss. Newer therapies require careful consideration by clinicians and formulary decision-makers with regard to suitability within the treatment pathway and the decision of whether the additional acquisition cost, relative to older glucose-lowering therapies, is justified.
In this article, we explore the question of whether a weight management pathway for people with type 2 diabetes meeting NICE (2009; 2010; 2012) guidance criteria for treatment with glucagon-like peptide-1 (GLP-1) receptor agonists could improve self-management behaviours and overall outcomes.
Rationale and guiding principles for change
The UK is faced with not only a growing number of people with diabetes, as mentioned above, but also a limited capacity of healthcare resources (NHS Diabetes, 2010). Thus, the economic case for any new diabetes treatment must be carefully considered. Treatment with GLP-1 receptor agonists has been shown to reduce HbA1c and promote weight loss, as reflected in clinical guidelines and technology appraisals (NICE, 2009; 2010; 2012). Such documentation from NICE endorses the cost-effectiveness of these agents in appropriate circumstances. As such, the initiation and continuation of treatment require certain criteria to be met (described later).
Results from an audit that took place in 2009 in our NHS trust led to recommendations that a pathway of care be established for add-on GLP-1 receptor agonist therapy to target and support motivated individuals, with the goal of improving overall therapeutic outcomes.
Innovative ways of working, such as a new clinical pathway, have the potential to generate efficiencies for organisations, and it is important that they are underpinned by audit and research (Royal College of Nursing, 2010). Therefore, following the above recommendation, a pilot study was conducted to trial and collect data on a new patient pathway (Figure 1). The aims of implementing the pathway, and associated means of support, were as follows:
- To incorporate an evidence-based approach to structured education.
- To promote self-management.
- To empower individuals to improve achievement of therapeutic targets and promote the likelihood of successful outcomes.
- To enhance adherence to NICE (2009; 2010; 2012) guidance regarding the use of GLP-1 receptor agonists.
We took an approach that would use motivational interviewing techniques to engage individuals and would work to the philosophy of “no decision about me, without me”.
The pathway was designed to meet components of the NICE (2011) Quality Standard on diabetes in adults, including structured education, lifestyle modification and the agreement of personal targets.
Considering these intended qualities of the pathway further, it is well established that structured education is a cornerstone of the therapeutic package for people with type 2 diabetes, and should be available at diagnosis and then as required (Department of Health, 2003; NICE, 2011). Such education should promote self-care and empowerment, rather than being delivered passively in a manner likely to lead to dependence (Funnell, 2004). There is much evidence to suggest that self-management improves psychological health, empowers people and enhances self-efficacy (Anderson, 2012). Various healthcare roles can help support this in the context of diabetes.
Evolving government strategy has reflected a growing acknowledgement of the importance of the nurse’s role in promoting lifestyle choices and self-care (Department of Health, 2006). Additionally, there are recommendations for specialist dietitians to take a major role in nutritional care (Diabetes UK, 2011). Various other groups of healthcare professionals, of course, have a role to play, but the importance of self-management should not be neglected. Indeed, it should be an ongoing and integral part of diabetes care, including its pharmacological management.
Implementing the pathway
Agreement to pilot the pathway for a period of 12 months was sought from our colleagues in primary care, with a view to introducing it as a management approach across the clinical commissioning group, if results were persuasive.
Suitable individuals were identified in primary care as those meeting NICE (2009; 2010; 2012) criteria for the initiation of add-on GLP-1 receptor agonist treatment in the third-line setting (Figure 1). Individuals attended an appointment with their practice nurse and diabetes specialist nurse to discuss the importance of lifestyle modification and to agree targets for change to strive towards during the next month. After 1 month, targets were reviewed and in individuals displaying motivation to change (evidence of weight loss or
positive self-management behaviours [i.e. self-reported positive lifestyle changes during the month]), add-on GLP-1 receptor agonist treatment was initiated.
During the first 6 months of treatment, people for whom the treatment was initiated attended monthly review appointments with their practice nurse and four group education sessions led by a specialist dietitian. The curriculum included calorie awareness, understanding of food groups, peer review of food diaries, the behaviour-change cycle and understanding of GLP-1 receptor agonist action. The philosophy guiding the group education sessions was to take a patient-centred approach and to encourage active goal-setting.
People entering the pathway kept their own record sheet for weight, HbA1c and goal-setting throughout, in order to facilitate shared decision-making.
Individuals were weighed at baseline during their first appointment at their practice, and then on a monthly basis during practice nurse follow-up and during group education sessions. HbA1c data were collected at baseline and 6 months (or, in some instances, later) after starting the pathway. Results were compared with those of a previous audit of HbA1c and weight loss data in individuals starting GLP-1 receptor agonist treatment in the same geographical area, but without this treatment pathway.
Results
Twenty-eight people started the pathway and attended at least one session and 23 people completed the pathway to 7 months (1 month from the first to the second joint clinic and a further 6 months to the third joint clinic). Data from these are presented below.
HbA1c
HbA1c data at 0 and 7 months were available for 22 individuals. Of these, 82% (n=18) experienced a reduction in HbA1c. The average reduction in HbA1c was 18.6 mmol/mol (1.7 percentage points), with a standard deviation (SD) of 10.5 mmol/mol (1.0 percentage point). Fifty-five per cent (n=12) of individuals achieved the NICE (2009; 2010; 2012) criterion of a reduction of at least 11 mmol/mol (1 percentage point) in HbA1c after 6 months of treatment.
Weight loss
Weight data at 0 and 7 months were available for 16 individuals. Of these, 81% (n=13) lost weight. The average weight loss was 6.2% (SD, 5.1%) of body weight. Seventy-five per cent of individuals (n=12) achieved the NICE (2009; 2010; 2012) criterion of at least 3% body weight loss after 6 months of treatment.
Combined criteria
In some individuals we only had HbA1c data and in others we only had weight data, and thus the proportion achieving both targets could not be meaningfully analysed.
Comparative data
An audit in 2009 within the same NHS trust, which pre-dated the pilot of the patient pathway described here, provides the best available comparative data. At that time, people with diabetes were not selected for add-on GLP-1 receptor agonist treatment on the basis of their motivation to make lifestyle changes. They did not attend group structured education within the first 6 months of their treatment change.
The 2009 data showed that 26% met the NICE criterion for HbA1c reduction (Figure 2) and 48% of individuals met the criterion for weight loss (Figure 3). As can be observed in Figures 2 and 3, a marked improvement in outcomes was seen after implementation of the patient pathway and structured education sessions described above.
Since this was a post hoc comparison, the data are presented numerically only (i.e. without statistical hypothesis testing).
Discussion
It is important that any therapies and education programmes designed to help deliver improvements in glycaemic control or to support weight loss (which can itself help improve glycaemic control in type 2 diabetes [NICE, 2008; Diabetes UK, 2011]) are evidence-based and cost-effective.
An audit carried out in the same NHS trust prior to this pathway being introduced demonstrated that a smaller proportion of people with diabetes initiated on add-on GLP-1 receptor agonist treatment met NICE (2009; 2010; 2012) criteria for continuing the therapy at 6 months. Based on the improved results for HbA1c reduction and weight loss noted in our pilot study, we tentatively suggest that the use of a structured pathway and patient-centred group education programme can be effective as a method of improving outcomes in people taking GLP-1 receptor agonists and increasing the proportion of individuals who meet individual components of the NICE (2009; 2010; 2012) criteria to continue treatment after 6 months.
Contributors to success
On reflecting on the study, we believe that the following elements of the approach are likely to be potential contributors to such a success.
Targeting treatment to motivated patients
As described earlier, GLP-1 receptor agonists can improve glycaemic control and promote weight loss in people with type 2 diabetes. Dietary and other lifestyle changes can also have a clinically significant effect on both weight and glycaemia (Diabetes UK, 2011). As such, particularly successful outcomes might intuitively be expected when using GLP-1 receptor agonists in individuals who are more willing to make lifestyle changes.
Use of structured education
Structured education is recommended by NICE as a means of providing people with diabetes with information needed to manage their own condition, and it has also been recognised as an effective means of promoting a partnership approach between healthcare professionals and patients (NICE, 2008; 2009).
The patient pathway reported here incorporated a four-part structured education programme to provide individuals with the necessary information to make appropriate lifestyle choices. Dietary information discussed was evidence-based in accordance with current nutritional guidelines (Diabetes UK, 2011).
In addition, the approach was one of allowing individuals time to discuss information, review their own dietary patterns, ask questions and set their own goals. Thus, the structured education promoted patient empowerment and systematic processing of information, which has previously been linked to improved behaviour change (Anderson et al, 1995).
Feedback following the group sessions demonstrated patient-perceived value of the above approach. When asked what the most useful part of the sessions was, responses included:
“Group discussions, individual stories and ideas.”
“It helps to talk to others and their experience.”
“Listening to other people as well as to the dietitian.”
Autonomous decision-making
The promotion among patients of autonomous decision-making and self-management has previously been linked to improved glycaemic control (Williams et al 1998). Our approach encouraged self-management through the use of hand-held records that people entering the pathway could use to monitor their weight and HbA1c level and to set appropriate goals.
Regular support
While autonomous decision-making was promoted throughout, ongoing support was available to facilitate and encourage appropriate changes. Individuals were invited to monthly reviews with their practice nurse to discuss concerns, which supplemented the group education sessions. Throughout the pilot, a partnership approach between patients and healthcare professionals was encouraged.
Limitations of the research
There are two particular limitations of the research that are important to note. The first is that we did not have controlled comparative data. The second is that our overall numbers were small. As such, caution must be exercised in interpreting the comparisons made.
Nevertheless, we feel that our results are useful not only in meeting audit needs within our locality and, more widely, in guiding future pilots and other research. In particular, with sufficient resources it would be beneficial to build on this research with a larger sample size, an exploration of people meeting both targets, and a formally controlled comparison – ideally via randomisation – capturing, among other outcomes, data for health-economic modelling.
Implications for future practice
We believe that the approaches discussed above are likely to have enhanced the positive outcomes for people initiated on add-on GLP-1 receptor agonist treatment. In the locality where the pathway was implemented, the evidence gathered was considered to be sufficient to recommend its continuation. We feel that this particular approach, or a similar pathway including structured education, could be considered for implementation in other areas.
Feedback from people entering the pilot indicated an interest in ongoing support. Future studies could consider how best to achieve this. The use of ongoing structured education, for example, may provide a cost-effective approach. Further data collection will be advantageous in order to determine the long-term benefits of this existing pathway and how best to maintain outcomes.
Acknowledgement
This work was done in contracted hours time and no extra funding was required. There are no conflicts of interest.
