Abstract
Aim: To explore the influence of clinical exercise trial participation on glycaemia and insulin therapy use in adults with type 1 diabetes (T1D).Research Design and Methods: This study involved a secondary analysis of data collected from 16 individuals with T1D who completed a randomized clinical trial consisting of 23-h in-patient phases with a 45-min evening bout of moderate intensity continuous exercise. Participants were switched from their usual basal-bolus therapy to ultra-long acting insulin degludec and rapid-acting insulin aspart as well as provided with unblinded interstitial flash-glucose monitoring systems. To assess the impact of clinical trial participation, weekly data obtained at the screening visit (pre-study involvement) were compared against those collated on the last experimental visit (post-study involvement). Interstitial glucose [iG] data were split into distinct glycaemic ranges and stratified into day (06:00–23:59) and night (00:00–05:59) time periods. A p-value of ≤ 0.05 was accepted for significance.Results: Following study completion, there were significant decreases in both the mean nocturnal iG concentration (Δ-0.9 ± 4.5 mmol.L−1, p < 0.001) and the time spent in severe hyperglycaemia (Δ-7.2 ± 9.8%, p = 0.028) during the night-time period. The total daily (Δ-7.3 ± 8.4 IU, p = 0.003) and basal only (Δ-2.3 ± 3.8 IU, p = 0.033) insulin dose requirements were reduced over the course of study involvement.Conclusions: Participation in clinical research may foster improved nocturnal glycaemia and reduced insulin therapy use in people with T1D. Recognition of these outcomes may help encourage volunteers to partake in clinical research opportunities for improved diabetes-related health outcomes.Clinical Trial Registration: DRKS.de; DRKS00013509.
Highlights
Volunteering as a research participant displays altruism and a willingness to help advance medical science
For individuals with type 1 diabetes (T1D), pharmaceutical developments in modern ultralong acting basal insulins with refined pharmacokinetic and pharmacodynamic profiles have led to improved glycaemic outcomes [4,5,6,7,8,9,10]
Though exercise is endorsed by several international consensus panels as an integral component of the treatment plan of those with T1D [18,19,20,21], participation rates remain low, with fears around loss of glycaemic control and uncertainty in how to appropriately adjust exogenous insulin therapy cited as leading factors dissuading regular engagement [22]
Summary
Volunteering as a research participant displays altruism and a willingness to help advance medical science. Interactive opportunities with health care professionals who offer medical information and support can foster positive psychosocial and glycaemic outcomes [15,16,17]. These pharmaceutical, technological, and physiological aids are complemented by lifestyle factors, including both diet and physical activity. The metabolic challenges evoked by physical exercise may persist for several hours subsequent to its cessation [26,27,28,29] This often extends the risk of dysglycaemia leading into and throughout the nocturnal period, at a time when self-monitoring of blood glucose is inherently difficult. Research trials that include any of these elements may have clinically relevant outcomes beyond the those solely pertinent to answering the primary outcome
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