The use of diabetes technologies is increasing worldwide, with health systems facilitating improved access to devices. Continuous glucose monitoring is a complex intervention that provides ...information on glucose concentration, rate and direction of change, historical data and alerts and alarms for extremes of glucose. These data do not themselves change glycaemia and require translation to a meaningful action for impact. It is, therefore, crucial that such systems advance to better meet the needs of individuals using them.
Narrative review of the use of, engagement with, limitations and unmet needs of continuous glucose monitoring systems.
CGM devices have made a significant contribution to the self-management of diabetes; however, challenges with access and user experience persist, with multiple limitations to uptake and benefit. These limitations include physical size and implementation, with associated stigma, alarm fatigue, sleep disturbance and the challenge of addressing large volumes of real-time data. Greater personalisation throughout the continuous glucose monitoring journey, with a focus on usability, may improve the benefits derived from the device and reduce the burden of self-management. Healthcare professionals may have unconscious biases that affect the provision of continuous glucose monitors due to deprivation, education, age, ethnicity and other characteristics.
Continuous glucose monitoring exerts a dose-dependent response; the more it is used, the more effective it is. For optimal use, continuous glucose monitors must not just reduce the burden of management in one dimension but facilitate net improvement in all domains of self-management for all users.
Aim
To better understand the prevalence of self‐reported psychosocial burdens and the unmet needs identified by people with diabetes in relation to routine diabetes visits.
Methods
An English ...language, online survey was distributed via social media, key stakeholder networks, charity and advocacy groups to adults with type 1 diabetes or type 2 diabetes. Survey items were designed by members of the FDA RESCUE Collaborative Community Governing Committee prior to pilot testing with potential participants. Descriptive statistical analyses were conducted, as well as thematic analyses on free‐text responses using NVivo v14.
Results
Four hundred and seventy‐eight participants completed the survey: 373 (78%) had type 1 diabetes, 346 (73%) identified as a woman and 433 (91%) were white. Most participants had experienced self‐reported (rather than diagnosed) anxiety and depression (n = 323 and n = 313, respectively), as well as fear of low blood sugars (n = 294), low mood (n = 290) and diabetes‐related distress (n = 257). Sixty‐eight percent reported that diabetes had negatively affected self‐esteem, 62% reported the feelings of loneliness, but 93% reported that friends/family/work colleagues were supportive when needed. Two hundred and seventy‐two percent (57%) reported that their diabetes team had never raised the topic of mental health. The overwhelming majority stated that the best thing their diabetes team could do to help was to simply ask about mental well‐being, listen with empathy and without judgement, and practice skills to understand psychosocial issues in diabetes.
Conclusion
Integrating psychosocial discussions and support within routine healthcare visits is crucial to improve outcomes for people with diabetes. Such a biopsychosocial model of healthcare has long been advocated by regulatory bodies.
The rising phenomenon of obesity, a major risk factor for the development and progression of type 2 diabetes, is a complex and multifaceted issue that requires a comprehensive and coordinated ...approach to be prevented and managed. Although novel pharmacological measures to combat obesity have achieved unprecedented efficacy, a healthy lifestyle remains essential for the long-term success of any therapeutic intervention. However, this requires a high level of intrinsic motivation and continued behavioural changes in the face of multiple metabolic, psychological and environmental factors promoting weight gain, particularly in the context of type 2 diabetes. This review is intended to provide practical recommendations in the context of a holistic, person-centred approach to weight management, including evidence-based and expert recommendations addressing supportive communication, shared decision-making, as well as nutritional and pharmacological therapeutic approaches to achieve sustained weight loss.
Abstract Aim Recently, efforts have been made to use and report person‐reported outcomes (PROs) in randomised clinical trials (RCTs). Here, we aim to (1) assess the status of inclusion of PROs in ...registered RCTs over 5 years in people with type 1 or 2 diabetes, and (2) map the PRO measures (PROMs) onto predefined domains. Methods The largest trial registries ( Clinicatrials.gov , International Clinical Trial Platform and ISRCTN) were systematically searched for RCTs in people with type 1 and/or type 2 diabetes of all ages between 2018 and 2023. Coding of PROs comprised: (1) PRO measure(s) included yes or no; if yes: (2) PRO(s) as primary outcome yes or no; and (3) mapping PROMs onto predefined PRO domains and per type of intervention. Results N = 1543 trials met our inclusion criteria, of which n = 673 (44%) included PROs, assessed by 545 different measures. Twenty per cent of drug trials ( n = 112) and 71% of behavioural interventions ( n = 405) included PROs. In 149 trials (9.6%), a PRO was the primary outcome. The psychological functioning domain was most often assessed across all trials (21.6%), specifically in behavioural (44.8%) and medical device interventions (29.7%). In drug trials, the physical functioning and functional health domain was most included (9%). Across all trials, the social and family functioning domain was least assessed (3%). Conclusions We noticed an increase in the inclusion of PROs in diabetes RCTs. However, PROs are rarely included as primary outcomes in the majority of studies, particularly in drug trials. The heterogeneity of PROMs used in RCTs underscores the need for standardisation of PROs.
Aim
To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first ...episode psychosis.
Materials and Methods
A double‐blind, randomized, placebo‐controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first‐episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once‐daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale.
Results
Seven hundred and ninety‐nine individuals were screened for eligibility. The most common reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The most commonly stated reason why eligible candidates declined to participate related to the study‐specific medication and protocol (n = 50). Forty‐seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference −6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group.
Conclusions
This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.
The National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. ...Manufacturers can trade in the UK with Conformité Européenne (CE) marking without an initial national assessment. The regulatory process for CGM CE marking, in contrast to the Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) process, is described. Manufacturers operating in the UK provided clinical accuracy studies submitted for CE marking. Critical appraisal of the studies shows several CGM devices have CE marking for wide‐ranging indications beyond available data, unlike FDA and TGA approval. The FDA and TGA use tighter controls, requiring comprehensive product‐specific clinical data evaluation. In 2018, the FDA published the integrated CGM (iCGM) criteria permitting interoperability. Applying the iCGM criteria to clinical data provided by manufacturers trading in the UK identified several study protocols that minimized glucose variability, thereby improving CGM accuracy on all metrics. These results do not translate into real‐life performance. Furthermore, for many CGM devices available in the UK, accuracy reported in the hypoglycaemic range is below iCGM standards, or measurement is absent. We offer a framework to evaluate CGM accuracy studies critically. The review concludes that FDA‐ and TGA‐approved indications match the available clinical data, whereas CE marking indications can have discrepancies. The UK can bolster regulation with UK Conformity Assessed marking from January 2025. However, balanced regulation is needed to ensure innovation and timely technological access are not hindered.
Aims
The FLASH‐UK trial showed lower HbA1c with intermittently scanned continuous glucose monitoring (isCGM), as compared with self monitoring of blood glucose (SMBG), in adults with type 1 diabetes ...and HbA1c ≥58 mmol/mol (≥7.5%). Here, we present results from the pre‐specified subgroup analysis for the 24‐week HbA1c (primary outcome) and selected sensor‐based secondary outcomes.
Methods
This was a multi‐centre, parallel‐design, randomised controlled trial. The difference in treatment effect between subgroups (baseline HbA1c ≤75 vs. >75 mmol/mol ≤9.0 vs >9.0%, treatment modality pump vs injections, prior participation in structured education, age, educational level, impaired awareness of hypoglycaemia, deprivation index quintile sex, ethnic group and Patient Health Questionnaire‐9 PHQ‐9 detected depression category) were evaluated.
Results
One hundred fifty‐six participants (females 44%, mean SD baseline HbA1c 71 9 mmol/mol 8.6 0.8%, age 44 15) were randomly assigned, in a 1:1 ratio to isCGM (n = 78) or SMBG (n = 78). The mean (SD) baseline HbA1c (%) was 8.7 (0.9) in the isCGM group and 8.5 (0.8) in the SMBG group, lowering to 7.9 (0.8) versus 8.3 (0.9), respectively, at 24 weeks (adjusted mean difference −0.5, 95% confidence interval CI −0.7 to −0.3; p < 0.001. For HbA1c, there was no impact of treatment modality, prior participation in structured education, deprivation index quintile, sex or baseline depression category. The between‐group difference in HbA1c was larger for younger people (a reduction of 2.7 95% CI 0.3–5.0; p = 0.028 mmol/mol for every additional 15 years of age). Those with HbA1c 76–97 mmol/mol (>9.0%–11.0%) had a marginally non‐significant higher reduction in HbA1c of 8.4 mmol/mol (3.3–13.5) compared to 3.1 (0.3–6.0) in those with HbA1c 58–75 mmol/mol (p = 0.08). For ‘Time in range’ (% 3.9–10 mmol/L), the difference was larger for those with at least a bachelor's degree. For ‘Time below range’ (% <3.9 mmol/L), the difference was larger for those using injections, older people and those with less than bachelor's degree.
Conclusions
Intermittently scanned continuous glucose monitoring is generally effective across a range of baseline characteristics.
Socioeconomic inequality of access to healthcare is seen across the spectrum of healthcare, including diabetes. Health inequalities are defined as the ‘preventable, unfair and unjust differences in ...health status between groups, populations or individuals that arise from the unequal distribution of social, environmental and economic conditions within societies, which determine the risk of people getting ill, their ability to prevent sickness or opportunities to take action and access treatment when ill health occurs’ (NHS England;
https://www.england.nhs.uk/about/equality/equality-hub/resources/
). Access to diabetes technologies has improved glycaemic and quality-of-life outcomes for many users. Inability to access such devices, however, is evidenced in National Diabetes Audit data, with a reported tenfold variation in insulin pump use by people with type 1 diabetes across specialist centres. This variation suggests a lack of access to healthcare systems that should be investigated. This article highlights some of the key issues surrounding healthcare inequalities in the management of diabetes.
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