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

Olivia McCarthy; Rachel Deere; Max L. Eckstein; Jason Pitt; Ben Wellman; Stephen C. Bain; Othmar Moser; Richard M. Bracken

doi:10.3389/fpubh.2020.568832

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

Olivia McCarthy, Rachel Deere, Max L. Eckstein, Jason Pitt, Ben Wellman, Stephen C. Bain, Othmar Moser, Richard M. Bracken

Department for Health

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	568832
Journal	Frontiers in Public Health
Volume	8
DOIs	https://doi.org/10.3389/fpubh.2020.568832
Publication status	Published - 7 Jan 2021

Bibliographical note

Funding Information:
This study was funded by Novo Nordisk as part of an investigator sponsored study.

Funding Information:
Conflict of Interest: 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.

Publisher Copyright:
© Copyright © 2021 McCarthy, Deere, Eckstein, Pitt, Wellman, Bain, Moser and Bracken.

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

exercise
glycaemia
insulin
research participant experience
type 1 diabetes (T1D)

ASJC Scopus subject areas

Public Health, Environmental and Occupational Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3389/fpubh.2020.568832Licence: CC BY

Cite this

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

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)",

author = "Olivia McCarthy and Rachel Deere and Eckstein, {Max L.} and Jason Pitt and Ben Wellman and Bain, {Stephen C.} and Othmar Moser and Bracken, {Richard M.}",

note = "Funding Information: This study was funded by Novo Nordisk as part of an investigator sponsored study. Funding Information: Conflict of Interest: 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 S{\^e}r 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. Publisher Copyright: {\textcopyright} Copyright {\textcopyright} 2021 McCarthy, Deere, Eckstein, Pitt, Wellman, Bain, Moser and Bracken. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

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doi = "10.3389/fpubh.2020.568832",

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AU - Deere, Rachel

AU - Eckstein, Max L.

AU - Pitt, Jason

AU - Wellman, Ben

AU - Bain, Stephen C.

AU - Moser, Othmar

AU - Bracken, Richard M.

N1 - Funding Information: This study was funded by Novo Nordisk as part of an investigator sponsored study. Funding Information: Conflict of Interest: 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. Publisher Copyright: © Copyright © 2021 McCarthy, Deere, Eckstein, Pitt, Wellman, Bain, Moser and Bracken. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/1/7

Y1 - 2021/1/7

N2 - 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.

AB - 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.

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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