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Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition

BACKGROUND: Individuals with type 1 diabetes represent a population with important vulnerabilities to dynamic physiological, behavioral, and psychological interactions, as well as cognitive processes. Ecological momentary assessment (EMA), a methodological approach used to study intraindividual vari...

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Autores principales: Mascarenhas Fonseca, Luciana, Strong, Roger W, Singh, Shifali, Bulger, Jane D, Cleveland, Michael, Grinspoon, Elizabeth, Janess, Kamille, Jung, Lanee, Miller, Kellee, Passell, Eliza, Ressler, Kerry, Sliwinski, Martin John, Verdejo, Alandra, Weinstock, Ruth S, Germine, Laura, Chaytor, Naomi S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9853340/
https://www.ncbi.nlm.nih.gov/pubmed/36602848
http://dx.doi.org/10.2196/39750
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author Mascarenhas Fonseca, Luciana
Strong, Roger W
Singh, Shifali
Bulger, Jane D
Cleveland, Michael
Grinspoon, Elizabeth
Janess, Kamille
Jung, Lanee
Miller, Kellee
Passell, Eliza
Ressler, Kerry
Sliwinski, Martin John
Verdejo, Alandra
Weinstock, Ruth S
Germine, Laura
Chaytor, Naomi S
author_facet Mascarenhas Fonseca, Luciana
Strong, Roger W
Singh, Shifali
Bulger, Jane D
Cleveland, Michael
Grinspoon, Elizabeth
Janess, Kamille
Jung, Lanee
Miller, Kellee
Passell, Eliza
Ressler, Kerry
Sliwinski, Martin John
Verdejo, Alandra
Weinstock, Ruth S
Germine, Laura
Chaytor, Naomi S
author_sort Mascarenhas Fonseca, Luciana
collection PubMed
description BACKGROUND: Individuals with type 1 diabetes represent a population with important vulnerabilities to dynamic physiological, behavioral, and psychological interactions, as well as cognitive processes. Ecological momentary assessment (EMA), a methodological approach used to study intraindividual variation over time, has only recently been used to deliver cognitive assessments in daily life, and many methodological questions remain. The Glycemic Variability and Fluctuations in Cognitive Status in Adults with Type 1 Diabetes (GluCog) study uses EMA to deliver cognitive and self-report measures while simultaneously collecting passive interstitial glucose in adults with type 1 diabetes. OBJECTIVE: We aimed to report the results of an EMA optimization pilot and how these data were used to refine the study design of the GluCog study. An optimization pilot was designed to determine whether low-frequency EMA (3 EMAs per day) over more days or high-frequency EMA (6 EMAs per day) for fewer days would result in a better EMA completion rate and capture more hypoglycemia episodes. The secondary aim was to reduce the number of cognitive EMA tasks from 6 to 3. METHODS: Baseline cognitive tasks and psychological questionnaires were completed by all the participants (N=20), followed by EMA delivery of brief cognitive and self-report measures for 15 days while wearing a blinded continuous glucose monitor. These data were coded for the presence of hypoglycemia (<70 mg/dL) within 60 minutes of each EMA. The participants were randomized into group A (n=10 for group A and B; starting with 3 EMAs per day for 10 days and then switching to 6 EMAs per day for an additional 5 days) or group B (N=10; starting with 6 EMAs per day for 5 days and then switching to 3 EMAs per day for an additional 10 days). RESULTS: A paired samples 2-tailed t test found no significant difference in the completion rate between the 2 schedules (t(17)=1.16; P=.26; Cohen d(z)=0.27), with both schedules producing >80% EMA completion. However, more hypoglycemia episodes were captured during the schedule with the 3 EMAs per day than during the schedule with 6 EMAs per day. CONCLUSIONS: The results from this EMA optimization pilot guided key design decisions regarding the EMA frequency and study duration for the main GluCog study. The present report responds to the urgent need for systematic and detailed information on EMA study designs, particularly those using cognitive assessments coupled with physiological measures. Given the complexity of EMA studies, choosing the right instruments and assessment schedules is an important aspect of study design and subsequent data interpretation.
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spelling pubmed-98533402023-01-21 Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition Mascarenhas Fonseca, Luciana Strong, Roger W Singh, Shifali Bulger, Jane D Cleveland, Michael Grinspoon, Elizabeth Janess, Kamille Jung, Lanee Miller, Kellee Passell, Eliza Ressler, Kerry Sliwinski, Martin John Verdejo, Alandra Weinstock, Ruth S Germine, Laura Chaytor, Naomi S JMIR Diabetes Original Paper BACKGROUND: Individuals with type 1 diabetes represent a population with important vulnerabilities to dynamic physiological, behavioral, and psychological interactions, as well as cognitive processes. Ecological momentary assessment (EMA), a methodological approach used to study intraindividual variation over time, has only recently been used to deliver cognitive assessments in daily life, and many methodological questions remain. The Glycemic Variability and Fluctuations in Cognitive Status in Adults with Type 1 Diabetes (GluCog) study uses EMA to deliver cognitive and self-report measures while simultaneously collecting passive interstitial glucose in adults with type 1 diabetes. OBJECTIVE: We aimed to report the results of an EMA optimization pilot and how these data were used to refine the study design of the GluCog study. An optimization pilot was designed to determine whether low-frequency EMA (3 EMAs per day) over more days or high-frequency EMA (6 EMAs per day) for fewer days would result in a better EMA completion rate and capture more hypoglycemia episodes. The secondary aim was to reduce the number of cognitive EMA tasks from 6 to 3. METHODS: Baseline cognitive tasks and psychological questionnaires were completed by all the participants (N=20), followed by EMA delivery of brief cognitive and self-report measures for 15 days while wearing a blinded continuous glucose monitor. These data were coded for the presence of hypoglycemia (<70 mg/dL) within 60 minutes of each EMA. The participants were randomized into group A (n=10 for group A and B; starting with 3 EMAs per day for 10 days and then switching to 6 EMAs per day for an additional 5 days) or group B (N=10; starting with 6 EMAs per day for 5 days and then switching to 3 EMAs per day for an additional 10 days). RESULTS: A paired samples 2-tailed t test found no significant difference in the completion rate between the 2 schedules (t(17)=1.16; P=.26; Cohen d(z)=0.27), with both schedules producing >80% EMA completion. However, more hypoglycemia episodes were captured during the schedule with the 3 EMAs per day than during the schedule with 6 EMAs per day. CONCLUSIONS: The results from this EMA optimization pilot guided key design decisions regarding the EMA frequency and study duration for the main GluCog study. The present report responds to the urgent need for systematic and detailed information on EMA study designs, particularly those using cognitive assessments coupled with physiological measures. Given the complexity of EMA studies, choosing the right instruments and assessment schedules is an important aspect of study design and subsequent data interpretation. JMIR Publications 2023-01-05 /pmc/articles/PMC9853340/ /pubmed/36602848 http://dx.doi.org/10.2196/39750 Text en ©Luciana Mascarenhas Fonseca, Roger W Strong, Shifali Singh, Jane D Bulger, Michael Cleveland, Elizabeth Grinspoon, Kamille Janess, Lanee Jung, Kellee Miller, Eliza Passell, Kerry Ressler, Martin John Sliwinski, Alandra Verdejo, Ruth S Weinstock, Laura Germine, Naomi S Chaytor. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 05.01.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Diabetes, is properly cited. The complete bibliographic information, a link to the original publication on https://diabetes.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Mascarenhas Fonseca, Luciana
Strong, Roger W
Singh, Shifali
Bulger, Jane D
Cleveland, Michael
Grinspoon, Elizabeth
Janess, Kamille
Jung, Lanee
Miller, Kellee
Passell, Eliza
Ressler, Kerry
Sliwinski, Martin John
Verdejo, Alandra
Weinstock, Ruth S
Germine, Laura
Chaytor, Naomi S
Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition
title Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition
title_full Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition
title_fullStr Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition
title_full_unstemmed Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition
title_short Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition
title_sort glycemic variability and fluctuations in cognitive status in adults with type 1 diabetes (glucog): observational study using ecological momentary assessment of cognition
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9853340/
https://www.ncbi.nlm.nih.gov/pubmed/36602848
http://dx.doi.org/10.2196/39750
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