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Background: There is a lack of practical guidance about how to effectively mobilise knowledge at the pre-trial stage. Despite increased guidance on developing complex interventions in recent years, much of this focuses on the theory and principles behind high-quality intervention development, rather than the practical aspects of how this should be achieved. This paper shares the findings from an embedded, qualitative evaluation of the Collaborative Working Group (CWG) process, a structured approach we developed to iteratively refine a complex intervention prior to a randomised controlled trial. Methods: The CWG was designed and delivered to support iterative refinements to a complex intervention pre-trial as part of the DAFNEplus research programme, a large intervention development study to refine and pilot a self-management education programme for people with type 1 diabetes. The CWG comprised monthly teleconferences and four strategically timed face-to-face meetings throughout the pre-trial period to support knowledge sharing between the practitioners delivering the pilot intervention and the researchers evaluating it. We conducted an embedded qualitative study to elicit CWG members' experiences and to hear their views of the acceptability, feasibility and effectiveness of the approach. Data were generated through two focus groups with CWG members, four individual interviews with CWG facilitators and documentary analysis of meeting materials. Results: This qualitative evaluation shows that participants generally found the CWG to be an acceptable, feasible and useful approach to supporting complex intervention refinement pre-trial. The qualitative findings highlight five critical elements that shape the success and acceptability of the CWG approach: funnelling knowledge over time, negotiating trust, balancing practicalities, making epistemic compromises and managing power and hierarchy in decision-making. The findings highlight the need to build in adequate time and resources to support trust-building and knowledge sharing throughout each stage in the research process, in addition to the benefits of creating boundary-spanning roles. Conclusions: This paper showcases a practical approach to operationalising collaborative intervention refinement and development pre-trial, with tangible lessons and recommendations for future research teams. The paper adds new insights and practical guidance to the intervention development and knowledge mobilisation fields. [ABSTRACT FROM AUTHOR]

Aim: To examine the hypothesis that there would be ethnic differences in the relationship between ectopic fat and tissue‐specific insulin resistance (IR) across a spectrum of glucose tolerance in Black African (BA) and White European (WE) men. Materials and Methods: Fifty‐three WE men (23/10/20 normal glucose tolerance [NGT]/impaired glucose tolerance [IGT]/type 2 diabetes [T2D]) and 48 BA men (20/10/18, respectively) underwent a two‐step hyperinsulinaemic‐euglycaemic clamp with infusion of D‐[6,6‐2H2]‐glucose and [2H5]‐glycerol to assess hepatic, peripheral and adipose tissue IR. Magnetic resonance imaging was used to measure subcutaneous adipose tissue, visceral adipose tissue (VAT) and intrahepatic lipid (IHL). Associations between ectopic fat and IR were assessed using linear regression models. Results: There were no differences in tissue‐specific IR between ethnic groups at any stage of glucose tolerance. VAT level was consistently lower in the BA population; NGT (p = 0.013), IGT (p = 0.006) and T2D (p = 0.015). IHL was also lower in the BA compared with the WE men (p = 0.013). VAT and IHL levels were significantly associated with hepatic IR in the BA population (p = 0.001) and with peripheral IR in the WE population (p = 0.027). Conclusions: The present study suggests that BA and WE men exhibit the same degree of IR across a glucose tolerance continuum, but with lower VAT and IHL levels in the BA population, suggesting that IR may be driven by a mechanism other than increased ectopic fat accumulation in BA men. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Use of continuous glucose monitoring (CGM) has led to greater detection of hypoglycemia; the clinical significance of this is not fully understood. The Hypoglycaemia–Measurement, Thresholds and Impacts (Hypo-METRICS) study was designed to investigate the rates and duration of sensor-detected hypoglycemia (SDH) and their relationship with person-reported hypoglycemia (PRH) in people living with type 1 diabetes (T1D) and insulin-treated type 2 diabetes (T2D) with prior experience of hypoglycemia. RESEARCH DESIGN AND METHODS: We recruited 276 participants with T1D and 321 with T2D who wore a blinded CGM and recorded PRH in the Hypo-METRICS app over 10 weeks. Rates of SDH <70 mg/dL, SDH <54 mg/dL, and PRH were expressed as median episodes per week. Episodes of SDH were matched to episodes of PRH that occurred within 1 h. RESULTS: Median [interquartile range] rates of hypoglycemia were significantly higher in T1D versus T2D; for SDH <70 mg/dL (6.5 [3.8–10.4] vs. 2.1 [0.8–4.0]), SDH <54 mg/dL (1.2 [0.4–2.5] vs. 0.2 [0.0–0.5]), and PRH (3.9 [2.4–5.9] vs. 1.1 [0.5–2.0]). Overall, 65% of SDH <70 mg/dL was not associated with PRH, and 43% of PRH had no associated SDH. The median proportion of SDH associated with PRH in T1D was higher for SDH <70 mg/dL (40% vs. 22%) and SDH <54 mg/dL (47% vs. 25%) than in T2D. CONCLUSIONS: The novel findings are that at least half of CGM hypoglycemia is asymptomatic, even below 54 mg/dL, and many reported symptomatic hypoglycemia episodes happen above 70 mg/dL. In the clinical and research setting, these episodes cannot be used interchangeably, and both need to be recorded and addressed. [ABSTRACT FROM AUTHOR]

Introduction: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo‐METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin‐treated type 2 diabetes in real‐time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo‐METRICS app completion rates and factors associated with completion. Methods: Adults with diabetes recruited into the Hypo‐METRICS study were given validated patient‐reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo‐METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics. Results: In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45–66) years; diabetes duration 19 (11–27) years; HbA1c 57 (51–65) mmol/mol), median(IQR) overall app completion rate was 91 (84–96)%, ranging from 90 (81–96)%, 89 (80–94)% and 94(87–97)% for morning, afternoon and evening check‐ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion. Discussion: High app completion across all app domains and participant characteristics indicates the Hypo‐METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real‐time. [ABSTRACT FROM AUTHOR]

Aim: Experimental hypoglycaemia blunts the counterregulatory hormone and symptom responses to a subsequent episode of hypoglycaemia. In this study, we aimed to assess the associations between antecedent exposure and continuous glucose monitoring (CGM)‐recorded hypoglycaemia during a 1‐week period and the counterregulatory responses to subsequent experimental hypoglycaemia in people with type 1 diabetes. Materials and Methods: Forty‐two people with type 1 diabetes (20 females, mean ± SD glycated haemoglobin 7.8% ± 1.0%, diabetes duration median (interquartile range) 22.0 (10.5‐34.9) years, 29 CGM users, and 19 with impaired awareness of hypoglycaemia) wore an open intermittently scanned CGM for 1 week to detect hypoglycaemic exposure before a standardized hyperinsulinaemic‐hypoglycaemic [2.8 ± 0.1 mmol/L (50.2 ± 2.3 mg/dl)] glucose clamp. Symptom responses and counterregulatory hormones were measured during the clamp. The study is part of the HypoRESOLVE project. Results: CGM‐recorded hypoglycaemia in the week before the clamp was negatively associated with adrenaline response [β −0.09, 95% CI (−0.16, −0.02) nmol/L, p =.014], after adjusting for CGM use, awareness of hypoglycaemia, glycated haemoglobin and total daily insulin dose. This was driven by level 2 hypoglycaemia [<3.0 mmol/L (54 mg/dl)] [β −0.21, 95% CI (−0.41, −0.01) nmol/L, p =.034]. CGM‐recorded hypoglycaemia was negatively associated with total, autonomic, and neuroglycopenic symptom responses, but these associations were lost after adjusting for potential confounders. Conclusions: Recent exposure to CGM‐detected hypoglycaemia was independently associated with an attenuated adrenaline response to experimental hypoglycaemia in people with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Aims: To assess the cost‐effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment‐resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. Methods: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ‐5D‐5L); cost of utilisation of health services (using the adult services utilization schedule, AD‐SUS) and of programme implementation and curriculum delivery were measured. A cost‐utility analysis was undertaken using quality‐adjusted life years (QALYs) as a measure of trial participant outcome and cost‐effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. Results: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: −£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post‐randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost‐effectiveness, with an 85% probability of correctly inferring an INB > 0. Conclusions: Addressing health cognitions in people with treatment‐resistant hypoglycaemia achieved cost‐effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost‐effective adjunct to educational and technological solutions for problematic hypoglycaemia. [ABSTRACT FROM AUTHOR]

Objective: Very little is known about the circumstances under which hyperglycaemia aversion develops and is maintained. The present study aimed to identify psychological factors involved in the process of hyperglycaemia aversion and to understand how it affects people's self‐management of type 1 diabetes. Design: Qualitative, in‐depth interviews were used. Methods: A constructivist grounded theory study, using semi‐structured participant interviews, was undertaken to build a theoretical model of the process of hyperglycaemia aversion. Results: Eighteen participants were interviewed. Fifteen were considered hyperglycaemia averse and included in the analysis. A theoretical model was developed to describe and explain processes involved in hyperglycaemia aversion. Many participants held very high standards for themselves and often had a strong preference for control. While some participants described anxiety associated with higher blood glucose, the most proximal driver of their approach was self‐criticism and frustration associated with not meeting their own high standards for blood glucose. A number of attentional processes and beliefs, mostly related to hypoglycaemia, maintained and reinforced their blood glucose preference. Diabetes technology served as an enabler, raiser of standards, and additional critical judge of participants' hyperglycaemia aversion. Conclusions: The trans‐diagnostic concept of emotional over‐control is used to understand the proposed model of processes of hyperglycaemia aversion. The present study offers new insight which will aid clinicians in identifying and supporting those who may be at risk of psychological distress and harm associated with a preference for avoidance of higher blood glucose levels. [ABSTRACT FROM AUTHOR]