Design and Psychometrics for New Measures of Health-Related Quality of Life in Adults with Type 1 Diabetes: Type 1 Diabetes and Life (T1DAL)

AIMS: To use a three-phase process to develop and validate new self-report measures of diabetes-specific health-related quality of life (HRQOL) for adults with type 1 diabetes. We report on four versions of the Type 1 Diabetes and Life (T1DAL) measure for people age 18-25, 26-45, 46-60, and over 60 years. METHODS: We first conducted qualitative interviews to guide measure creation, then piloted the draft measures. We evaluated psychometric properties at six T1D Exchange Clinic Network sites via completion of T1DAL and validated measures of related constructs. Participants completed the T1DAL again in 4-6 weeks. We used psychometric data to reduce each measure to 23-27 items in length. Finally, we obtained participant feedback on the final measures. RESULTS: The T1DAL-Adult measures demonstrated good internal consistency (α=0.85-0.88) and test-retest reliability (r=0.77-0.87). Significant correlations with measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, self-management, and glycemic control demonstrated validity. Factor analyses yielded 4-5 subscales per measure. Participants were satisfied with the final measures and reported they took 5-10 minutes to complete. CONCLUSIONS: The strong psychometric properties of the newly developed self-report T1DAL measures for adults with type 1 diabetes make them appropriate for use in clinical research and care

Assessing Health-Related Quality of Life in Children and Adolescents with Diabetes: Development and Psychometrics of the Type 1 Diabetes and Life (T1DAL) Measures.

OBJECTIVE To develop and validate new measures of diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D) that are brief, developmentally appropriate, and usable in clinical research and care. Here we report on the phases of developing and validating the self-report Type 1 Diabetes and Life (T1DAL) measures for children (age 8-11) and adolescents (age 12-17). METHODS Measure development included qualitative interviews with youth and parents (n = 16 dyads) followed by piloting draft measures and conducting cognitive debriefing with youth (n = 9) to refine the measures. To evaluate the psychometric properties, children (n = 194) and adolescents (n = 257) at three T1D Exchange Clinic Network sites completed the age-appropriate T1DAL measure and previously validated questionnaires measuring related constructs. Using psychometric data, the investigators reduced the length of each T1DAL measure to 21 and 23 items, respectively, and conducted a final round of cognitive debriefing with six children and adolescents. RESULTS The T1DAL measures for children and adolescents demonstrated good internal consistency (α = 0.84 and 0.89, respectively) and test-retest reliability (r = 0.78 and 0.80, respectively). Significant correlations between the T1DAL scores and measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, and diabetes strengths demonstrated construct validity. Correlations with measures of self-management (child and adolescent) and glycemic control (adolescent only) demonstrated criterion validity. Factor analyses indicated four developmentally specific subscales per measure. Participants reported satisfaction with the measures. CONCLUSIONS The new T1DAL measures for children and adolescents with T1D are reliable, valid, and suitable for use in care settings and clinical research

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

BackgroundIndividuals 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. ObjectiveWe 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. MethodsBaseline 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). ResultsA paired samples 2-tailed t test found no significant difference in the completion rate between the 2 schedules (t17=1.16; P=.26; Cohen dz=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. ConclusionsThe 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

Design and psychometrics for new measures of health-related quality of life in adults with type 1 diabetes: Type 1 Diabetes and Life (T1DAL)

Aims: To use a three-phase process to develop and validate new self-report measures of diabetes-specific health-related quality of life (HRQOL) for adults with type 1 diabetes. We report on four versions of the Type 1 Diabetes and Life (T1DAL) measure for people age 18–25, 26–45, 46–60, and over 60 years. Methods: We first conducted qualitative interviews to guide measure creation, then piloted the draft measures. We evaluated psychometric properties at six T1D Exchange Clinic Network sites via completion of T1DAL and validated measures of related constructs. Participants completed the T1DAL again in 4–6 weeks. We used psychometric data to reduce each measure to 23–27 items in length. Finally, we obtained participant feedback on the final measures. Results: The T1DAL-Adult measures demonstrated good internal consistency (α = 0.85–0.88) and test–retest reliability (r = 0.77–0.87). Significant correlations with measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, self-management, and glycemic control demonstrated validity. Factor analyses yielded 4–5 subscales per measure. Participants were satisfied with the final measures and reported they took 5–10 min to complete. Conclusions: The strong psychometric properties of the newly developed self-report T1DAL measures for adults with type 1 diabetes make them appropriate for use in clinical research and care

Racial-Ethnic Inequity in Young Adults with Type 1 Diabetes

CONTEXT: Minority young adults (YA) currently represent the largest growing population with type 1 diabetes (T1D) and experience very poor outcomes. Modifiable drivers of disparities need to be identified, but are not well-studied. OBJECTIVE: To describe racial-ethnic disparities among YA with T1D, and identify drivers of glycemic disparity other than socioeconomic status (SES). DESIGN: Cross-sectional multi-center collection of patient and chart-reported variables, including SES, social determinants of health, and diabetes-specific factors, with comparison between White, Black, and Hispanic YA and multi-level modeling to identify variables that account for glycemic disparity apart from SES. SETTING: Six diabetes centers across the U.S. PARTICIPANTS: 300 YA with T1D (18-28 yrs: 33% Non-Hispanic White, 32% Non-Hispanic Black, and 34% Hispanic). MAIN OUTCOME: Racial-ethnic disparity in HbA1c levels. RESULTS: Black and Hispanic YA had lower SES, higher HbA1c levels, and much lower diabetes technology use than White YA (p\u3c0.001). Black YA differed from Hispanic, reporting higher diabetes distress and lower self-management (p\u3c0.001). After accounting for SES, differences in HbA1c levels disappeared between White and Hispanic YA, while they remained for Black YA (+ 2.26% [24 mmol/mol], p\u3c0.001). Diabetes technology use, diabetes distress, and disease self-management accounted for a significant portion of the remaining Black-White glycemic disparity. CONCLUSION: This study demonstrated large racial-ethnic inequity in YA with T1D, especially among Black participants. Our findings reveal key opportunities for clinicians to potentially mitigate glycemic disparity in minority YA by promoting diabetes technology use, connecting with social programs, and tailoring support for disease self-management and diabetes distress to promote resilience

Health-related quality of life in parents and partners of people with type 1 diabetes: Development and validation of type 1 diabetes and life (T1DAL) measures.

Introduction: Despite the significant impact of type 1 diabetes (T1D) on family, few instruments are available to assess health-related quality of life (HRQOL) among family members of people with T1D. This study aimed to develop and evaluate the psychometric properties of new measures of diabetes-specific HRQOL for parents and partners of people with T1D. We report on the multistep development and validation process for the self-report Type 1 Diabetes and Life (T1DAL) measures, with versions for parents of youth age <8, 8–11, 12–17, and 18–25 years, and for partners of people age ≥18 years with T1D. Method: First, we conducted qualitative interviews (total parents/partners n = 38) to develop draft measures and piloted them (total n = 20). Next, we tested the measures’ psychometric properties. Participants (total across versions n = 813) at six T1D Exchange Clinic Network sites completed the appropriate T1DAL measure and validated measures of related constructs. We then reduced each T1DAL measure to 20–30 items in length based on psychometric data and participant feedback. Eleven participants reviewed the final measures via cognitive debriefing. Results: The T1DAL measures for parents and partners demonstrated good internal consistency (α = .80–.88) and test–retest reliability (r = .73–.86). Correlations with measures of general quality of life, generic and diabetes-specific HRQOL, and diabetes burden demonstrated construct validity. Factor analyses identified 3–4 subscales/measure. Participants reported being satisfied with the shortened measures, which took 5–10 minutes to complete. Discussion: The new T1DAL measures for parents and partners of people with T1D are reliable, valid, and ready for use in research and clinical settings. (PsycInfo Database Record (c) 2021 APA, all rights reserved) Public Significance Statement—This study developed a set of validated questionnaires to measure health-related quality of life in parents and partners of people with type 1 diabetes. The experiences of family members are important and have implications for the health and well-being of people with diabetes, yet there have been few measures to accurately and reliably assess their quality of life. These new measures can be used in clinical practice and research settings. (PsycInfo Database Record (c) 2021 APA, all rights reserved

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes

OBJECTIVE: To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. RESEARCH DESIGN AND METHODS: WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults age ≥60 years with type 1 diabetes. Following the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. RESULTS: CGM was used a median of \u3e90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time \u3c70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks (p\u3c0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% versus 64%; p\u3c0.001) and had lower HbA1c (mean 7.6% [59mmol/mol] versus 7.4% [57mmol/mol]; p=0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time \u3c70 mg/dL decreased from 3.9% to 1.9% (p\u3c0.001), TIR increased from 56% to 60% (p=0.006) and HbA1c decreased from 7.5%[58mmol/mol] to 7.3%[57mmol/mol] (p=0.025). In BGM-CGM, a severe hypoglycemic event was reported for 9 participants while using BGM during the RCT and for 2 participants during the extension phase with CGM (p=0.02). CONCLUSIONS: CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial

Importance: Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective: To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions: Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures: The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results: Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P Conclusions and Relevance: Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes

To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. CGM was used a median of >90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time <70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks (  < 0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% vs. 64%;  < 0.001) and had lower hemoglobin A1c (HbA1c) (mean 7.6% [59 mmol/mol] vs. 7.4% [57 mmol/mol];  = 0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time <70 mg/dL decreased from 3.9% to 1.9% (  < 0.001), TIR increased from 56% to 60% (  = 0.006) and HbA1c decreased from 7.5% (58 mmol/mol) to 7.3% (57 mmol/mol) (  = 0.025). In BGM-CGM, a severe hypoglycemic event was reported for nine participants while using BGM during the RCT and for two participants during the extension phase with CGM (  = 0.02). CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice. Clinicaltrials.gov (NCT03240432)