For people with type 1 diabetes (T1DM), regular exercise can be highly beneficial. Although exercise has been shown to improve quality of life and health for people living with T1DM, there are common ...barriers. To examine such issues, we explored the perceived impact that automated insulin delivery systems could have on people with T1DM and their families. One common theme found was hopes, expectations and impact on sports and exercise. Four sites (United States: three; UK: one) were involved in this study. Two hundred and eighty‐four participants were recruited across all sites; participants comprised: children (9–11 years); adolescents (12–18 years); parents/caretakers of children and adolescents with T1DM; adults with T1DM (18–77 years); and their significant others/partners. Between May and December 2015, focus groups and semi‐structured interviews were conducted and analysed using content analysis. Three themes found related to the benefits of automated insulin delivery systems: (a) more freedom and spontaneity in the individual's ability to exercise; (b) relief from worry of hypoglycaemia as a result of exercise; (c) removing the ‘guesswork’ of adjusting insulin for exercise. Two further themes emerged relating to potential concerns with regard to safely exercising while wearing an automated insulin delivery system. Further research is encouraged with a view to providing accurate algorithms and increasing confidence for those using automated insulin delivery systems and, in turn, for their exercise colleagues and loved ones.
Abstract
Background
Existing therapeutic interventions to treat diabetes are well known, yet the majority of people with diabetes do not consistently achieve blood glucose targets (even individual ...therapy targets) for optimal health, despite the large range of treatment options available. Such outcomes have remained stubbornly poor for decades with <25% adults with diabetes achieving glycaemic targets. Patient behaviour, individually supported in routine clinical care, is an important missing component to improved outcomes, in a medical healthcare model not ideally suited to supporting successful diabetes management.
Methods
A multi-centre, parallel group, individually randomised trial comparing consultation duration in adults with type 1, type 2 or pre-diabetes using the Spotlight Consultations pre-clinic assessment compared to usual care in the Spotlight-AQ study. Two hundred adults with type 1, type 2 or pre-diabetes attending routine care outpatient appointments across up to ten participating sites will be invited to participate.
Intervention
An outpatient pre-clinic intervention delivered within 1 week prior to scheduled routine outpatient appointment.
Primary outcome measure
Duration of routine outpatient consultation.
Secondary outcome measures
Functional health status
Diabetes distress
Depression
Treatment satisfaction
Impact on self-care behaviours
HCP burnout
HCP treatment satisfaction and burden
Hypoglycaemia (time less than 70mg/dL)
Hyperglycaemia (time above 180 mg/dL)
Change in weight
Change in HbA
1c
Cost effectiveness of intervention
Discussion
Results from the study will provide valuable insights into patient-professional communication practices within routine care and recommendations will be made, as necessary, for improvements to that. If the intervention is shown to be clinically and cost-effective, the feedback from participants and healthcare professionals will be used to make any improvements prior to its deployment to support improved communication and associated health outcomes.
Ethics and dissemination
The trial was approved by the Wales REC7 Research Ethics Committee (21/WA/0020). Results will be disseminated through national and international conferences, scientific journals, newsletters, magazines and social media. Target audiences include consultants and other clinicians in diabetes, and medical professionals or scientists overall.
Trial registration
ISRCTN15511689
. Registered on 10 November 2021
Objective: Limited research has examined the impact of technology on intimacy and relationships among individuals with type 1 diabetes (T1D). The current study examined the experiences of individuals ...with T1D and their partners and evaluated the expectations for how advances in technology such as automated insulin delivery systems may impact physical intimacy. Method: The Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) study is a multisite study examining expectations for automated insulin delivery systems among adults and youth with T1D as well as partners and caregivers. For the current analysis, data regarding the impact of diabetes on relationship intimacy were extracted from focus groups or individual semistructured interviews with adults with T1D (n = 113) and partners of individuals with T1D (n = 55). Results: Three independent coders conducted thematic analysis utilizing NVivo software. Two primary themes were identified: vulnerability in romantic relationships because of managing diabetes and the unique challenges of physical intimacy because of the use of diabetes technology. Conclusions: Participants expressed the hope that diabetes technology, and automated insulin delivery systems in particular, will offer opportunities for flexibility in their diabetes management. These options may decrease their sense of vulnerability through provision of greater control over diabetes management and when/whether to disclose diabetes, minimizing discomforts in the context of sexual intimacy, and reduction of fear about diabetes complications. Patient-reported outcomes and expectations for diabetes technology should be incorporated into patient-provider conversations about sensitive issues.
Public Significance Statement
The present study identifies expectations among those with type 1 diabetes and their partners about how new diabetes technologies may impact intimacy. As these new technologies become more common, it is anticipated these results will be useful to care providers and clinicians when discussing how technology may impact a couple's physical relationship along with the benefits and challenges these technologies provide with their patients.
Therapeutic inertia and suboptimal adherence to therapy have been cited as key contributors to poor diabetes outcomes. Although many of the factors associated with therapeutic inertia and adherence ...are often beyond the control of both patients and health care providers, most factors can be addressed through improved patient-provider communications.Use of telemedicine and electronic health (eHealth) technologies has the potential to address these factors, and thus, improve management of diabetes, increase access to care, and diminish inequalities in providing health care services. This article examines the behavioral aspects of the eHealth and telemedicine technologies, discusses how patient-centered care can be delivered effectively using eHealth and telemedicine, and reviews a novel model of care, KALMOD, which addresses a range of factors that are critical to improving patient-provider communications and collaborations.
People with severe mental illness are two to three times more likely to be overweight or have obesity than the general population and this is associated with significant morbidity and premature ...mortality. Liraglutide 3 mg is a once daily injectable GLP-1 receptor agonist that is licensed for the treatment of obesity in the general population and has the potential to be used in people with severe mental illness.
To record the expectations and experiences of people with schizophrenia, schizoaffective disorders or first episode psychosis taking daily liraglutide 3 mg injections in a clinical trial for the treatment of obesity. To seek the views of healthcare professionals about the feasibility of delivering the intervention in routine care.
Qualitative interviews were undertaken with a purposive sub-sample of people with schizophrenia, schizoaffective disorders or first episode psychosis with overweight or obesity who were treated with a daily injection of liraglutide 3 mg in a double-blinded, randomised controlled pilot study evaluating the use of liraglutide for the treatment of obesity. Interviews were also conducted with healthcare professionals.
Seventeen patient participants were interviewed. Sixteen took part in the baseline interview, eight completed both baseline and follow-up interviews, and one took part in follow-up interview only. Mean interview duration was thirteen minutes (range 5-37 min). Despite reservations by some participants about the injections before the study, most of those who completed the trial reported no challenges in the timing of or administering the injections. Key themes included despondency regarding prior medication associated weight gain, quality of life impact of weight loss, practical aspects of participation including materials received and clinic attendance. Healthcare professionals reported challenges with recruitment, however, overall it was a positive experience for them and for participants.
Liraglutide appears to be an acceptable therapy for obesity in this population with limited side effects. The quality of life benefits realised by several intervention participants reinforce the biomedical benefits of achieved weight loss.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
People with severe mental illness (SMI) are two to three times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature ...mortality. Although lifestyle interventions can support people with SMI to lose weight, some are unable to make the necessary lifestyle changes or, despite making the changes, continue to gain weight.
To assess the feasibility and acceptability of delivering a full-scale trial evaluating whether liraglutide 3.0 mg, a once-daily injectable therapy, may be an effective treatment of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis.
Design: a single-centre, double-blind, randomised, placebo-controlled trial.
mental health facilities within Southern Health NHS Trust.
60 adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication will be recruited. Participants will be overweight or obese, defined by their baseline BMI which will be: • BMI ≥ 30 kg/m
or • BMI ≥ 27 kg/m
to < 30 kg/m
in the presence of at least one weight-related consequence. This is in concordance with the current EU licence for liraglutide (maximum dosage 3.0 mg).
participants will be allocated in a 1:1 ratio using a computer-based randomisation programme to either once-daily subcutaneously administered liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. All participants will receive standardised written information about healthy eating and exercise at their randomisation visit.
the main aim of the study is to gather data on recruitment, consent, retention and adherence. Qualitative interviews with a purposive sub-sample of participants and healthcare workers will provide data on intervention feasibility and acceptability. Secondary clinical outcome measurements will be assessed at 3 and 6 months and will include: weight, fasting plasma glucose, lipid profile, HbA
level; and the Brief Psychiatric Rating Scale.
This study should provide evidence of the potential benefits of liraglutide (maximum dosage 3.0 mg daily) on body weight and metabolic variables in people with schizophrenia, schizoaffective disorder and first-episode psychosis. It will also address the feasibility and acceptability of the use of liraglutide in mental health settings. This will inform the design of a longer outcome study that will be needed to determine whether any weight loss can be maintained in the long term.
Universal Trial Number (UTN), ID: U1111-1203-0068. Registered on on 2/10/2017. European Clinical Trials Database (EudraCT), ID: 2017-004064-35. Registered on 3/10/2017.
IntroductionOptimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care ...self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG.MethodsThis open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%–11%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected.AnalysisEfficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed.EthicsThe study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants.Trial registration numberNCT03815006.Protocol version4.0 dated 29 June 2020.
Background There are over 2000 pregnancies annually in women with type 1 diabetes in the UK. Despite recent improvements in diabetes technology, most women cannot achieve and maintain the recommended ...pregnancy glucose targets. Thus, one in two babies experience complications requiring neonatal care unit admission. Recent studies demonstrate that hybrid closed-loop therapy, in which algorithms adjust insulin delivery according to continuous glucose measurements, is effective for managing type 1 diabetes outside of pregnancy, but efficacy during pregnancy is unclear. Objective To examine the clinical efficacy of hybrid closed-loop compared to standard insulin therapy in pregnant women with type 1 diabetes. Design A multicentre, parallel-group, open-label, randomised, controlled trial in pregnant women with type 1 diabetes. Setting Nine antenatal diabetes clinics in England, Scotland and Northern Ireland. Participants Pregnant women with type 1 diabetes and above-target glucose levels, defined as glycated haemoglobin A1c of ≥ 48 mmol/mol (6.5%) in early pregnancy. Interventions A hybrid closed-loop system compared to standard insulin delivery (via insulin pump or multiple daily injections) with continuous glucose monitoring. Outcome measures The primary outcome is the difference between the intervention and control groups in percentage time spent in the pregnancy glucose target range (3.5–7.8 mmol/l) as measured by continuous glucose monitoring from 16 weeks’ gestation until delivery. Secondary outcomes include overnight time in range, time above range (> 7.8 mmol/l), glycated haemoglobin A1c, safety outcomes (diabetic ketoacidosis, severe hypoglycaemia, adverse device events), psychosocial functioning obstetric and neonatal outcomes. Results The percentage of time that maternal glucose levels were within target range was higher with closed-loop than standard insulin therapy: 68.2 ± 10.5 in closed-loop and 55.6 ± 12.5 in the control group (mean‑adjusted difference 10.5 percentage points, 95% confidence interval 7.0 to 14.0; p < 0.001). Results were consistent in secondary outcomes, with less time above range (−10.2%, 95% confidence interval −13.8 to −6.6%; p < 0.001), higher overnight time in range (12.3%, 95% confidence interval 8.3 to 16.2%; p < 0.001) and lower glycated haemoglobin A1c (−0.31%, 95% confidence interval −0.50 to −0.12%; p < 0.002) all favouring closed-loop. The treatment effect was apparent from early pregnancy and consistent across clinical sites, maternal glycated haemoglobin A1c categories and previous insulin regimen. Maternal glucose improvements were achieved with 3.7 kg less gestational weight gain and without additional hypoglycaemia or total daily insulin dose. There were no unanticipated safety problems (six vs. five severe hypoglycaemia cases, one diabetic ketoacidosis per group) and seven device-related adverse events associated with closed-loop. There were no between-group differences in patient-reported outcomes. There was one shoulder dystocia in the closed-loop group and four serious birth injuries, including one neonatal death in the standard care group. Limitations Our results cannot be extrapolated to closed-loop systems with higher glucose targets, and our sample size did not provide definitive data on maternal and neonatal outcomes. Conclusions Hybrid closed-loop therapy significantly improved maternal glycaemia during type 1 diabetes pregnancy. Our results support National Institute for Health and Care Excellence guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes. Future work Future trials should examine the effectiveness of hybrid closed-loop started before pregnancy, or as soon as possible after pregnancy confirmation. Trial registration This trial is registered as ISRCTN56898625. Funding This award was funded by the National Institute of Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 16/35/01) and is published in full in Efficacy and Mechanism Evaluation ; Vol. 11, No. 7. See the NIHR Funding and Awards website for further award information. Dexcom supplied the continuous glucose monitoring systems used by AiDAPT intervention- and control-arm participants at reduced cost.
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