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Randomized Controlled Trial
. 2021 Jan 7:8:568832.
doi: 10.3389/fpubh.2020.568832. eCollection 2020.

Improved Nocturnal Glycaemia and Reduced Insulin Use Following Clinical Exercise Trial Participation in Individuals With Type 1 Diabetes

Olivia McCarthy  1 , Rachel Deere  2 , Max L Eckstein  3   4 , Jason Pitt  1 , Ben Wellman  1 , Stephen C Bain  5 , Othmar Moser  3   4 , Richard M Bracken  1
Affiliations
Randomized Controlled Trial

Improved Nocturnal Glycaemia and Reduced Insulin Use Following Clinical Exercise Trial Participation in Individuals With Type 1 Diabetes

Olivia McCarthy et al. Front Public Health. .

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.

Keywords: exercise; glycaemia; insulin; research participant experience; type 1 diabetes (T1D).

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Conflict of interest statement

The authors declare that this study was funded by Novo Nordisk A/S as part of an investigator sponsored study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. OMc* has received a Zienkiewcz scholarship and travel grants from Novo Nordisk. OMo has received lecture fees from Medtronic, travel grants from Novo Nordisk A/S, Novo Nordisk AT, Novo Nordisk UK and Medtronic AT, research grants from Sêr Cymru II COFUND fellowship/European Union, Sanofi-Aventis, Novo Nordisk A/S, Novo Nordisk AT, Dexcom Inc., as well as material funding from Abbott Diabetes Care. ME has received a KESS2/European Social Fund scholarship and travel grants from Novo Nordisk A/S and Sanofi-Aventis. SB has received research grants (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) from Health care and Research Wales (Welsh Government) and Novo Nordisk. He has received other research support from Healthcare and Research Wales (Welsh Government), honoraria from Novo Nordisk, Sanofi, Lilly, Boehringer Ingelheim and Merck, and has an ownership interest in Glycosmedia (diabetes on-line news service). RB reports having received honoraria, travel, and educational grant support from Boehringer-Ingelheim, Eli Lilly and Company, Novo Nordisk, and Sanofi-Aventis. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Schematic overview of the trial design with reference to the four interventional cross over arms involving peri-exercise adjustments to bolus insulin aspart on a stable background of insulin degludec. IAsp, insulin aspart; IDeg, insulin degludec.
See this image and copyright information in PMC

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