Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App:Survey and Interview Study

Background: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. Objective: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. Methods: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. Results: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. Conclusions: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual’s daily functioning. Despite suggested improvements, participants’ responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact.</p

Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App:Survey and Interview Study

Background: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. Objective: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. Methods: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. Results: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. Conclusions: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual’s daily functioning. Despite suggested improvements, participants’ responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact.</p

Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo- METRICS study:Hypoglycaemia MEasurements ThResholds and ImpaCtS

Introduction: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1and insulin-treated type 2 diabetes in real-time using ecological momentary assessment(EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion.Methods: Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics.Results: In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45-66)years; diabetes duration 19 (11-27) years; HbA1c 57 (51-65) mmol/mol), median(IQR)overall app completion rate was 91 (84-96)%, ranging from 90 (81-96)%, 89 (80-94)% and94(87-97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion.Discussion: High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time

Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo- METRICS study:Hypoglycaemia MEasurements ThResholds and ImpaCtS

Introduction: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1and insulin-treated type 2 diabetes in real-time using ecological momentary assessment(EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion.Methods: Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics.Results: In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45-66)years; diabetes duration 19 (11-27) years; HbA1c 57 (51-65) mmol/mol), median(IQR)overall app completion rate was 91 (84-96)%, ranging from 90 (81-96)%, 89 (80-94)% and94(87-97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion.Discussion: High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time

Associations Between Hypoglycemia Awareness Status and Symptoms of Hypoglycemia Among Adults with Type 1 or Insulin-Treated Type 2 Diabetes Using the Hypo-METRICS Smartphone Application

Introduction: This study examined associations between hypoglycemia awareness status and hypoglycemia symptoms reported in real-time using the novel Hypoglycaemia-MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone application (app) among adults with insulin-treated type 1 (T1D) or type 2 diabetes (T2D). Methods: Adults who experienced at least one hypoglycemic episode in the previous 3 months were recruited to the Hypo-METRICS study. They prospectively reported hypoglycemia episodes using the app for 10 weeks. Any of eight hypoglycemia symptoms were considered present if intensity was rated between "A little bit" to "Very much" and absent if rated "Not at all." Associations between hypoglycemia awareness (as defined by Gold score) and hypoglycemia symptoms were modeled using mixed-effects binary logistic regression, adjusting for glucose monitoring method and diabetes duration. Results: Of 531 participants (48% T1D, 52% T2D), 45% were women, 91% white, and 59% used Flash or continuous glucose monitoring. Impaired awareness of hypoglycemia (IAH) was associated with lower odds of reporting autonomic symptoms than normal awareness of hypoglycemia (NAH) (T1D odds ratio [OR] 0.43 [95% confidence interval {CI} 0.25-0.73], P = 0.002); T2D OR 0.51 [95% CI 0.26-0.99], P = 0.048), with no differences in neuroglycopenic symptoms. In T1D, relative to NAH, IAH was associated with higher odds of reporting autonomic symptoms at a glucose concentration &lt;54 than &gt;70 mg/dL (OR 2.18 [95% CI 1.21-3.94], P = 0.010). Conclusion: The Hypo-METRICS app is sensitive to differences in hypoglycemia symptoms according to hypoglycemia awareness in both diabetes types. Given its high ecological validity and low recall bias, the app may be a useful tool in research and clinical settings. The clinical trial registration number is NCT04304963.</p

Gestational diabetes treatment: Associations with maternal characteristics and offspring outcomes in the Born in Bradford study

Gestational diabetes treatment: Associations with maternal characteristics and offspring outcomes in the Born in Bradford stud

Relationships between exposure to gestational diabetes treatment and neonatal anthropometry: Evidence from the Born in Bradford (BiB)

Objectives To examine the relationships between gestational diabetes mellitus (GDM) treatment and neonatal anthropometry. Methods Covariate-adjusted multivariable linear regression analyses were used in 9,907 offspring of the Born in Bradford cohort. GDM treatment type (lifestyle changes advice only, lifestyle changes and insulin or lifestyle changes and metformin) was the exposure, offspring not exposed to GDM the control, and birth weight, head, mid-arm and abdominal circumference, and subscapular and triceps skinfold thickness the outcomes. Results Lower birth weight in offspring exposed to insulin (-117.2g (95% CI -173.8,-60.7)) and metformin (-200.3g (-328.5,-72.1)) than offspring not exposed to GDM was partly attributed to lower gestational age at birth and greater proportion of Pakistani mothers in the treatment groups. Higher subscapular skinfolds in offspring exposed to treatment compared to offspring not exposed to GDM was partly attributed to higher maternal glucose concentrations at diagnosis. In fully adjusted analyses, GDM treatment was associated with lower weight, smaller abdominal circumference and skinfolds at birth than offspring not exposed to GDM. Metformin was associated with smaller mid-arm circumference (-0.3cm (-0.6,-0.07)) than insulin in fully adjusted models with no other differences found. Conclusions for Practice Offspring exposed to GDM treatment were lighter and smaller at birth than offspring not exposed to GDM. Metformin-exposed offspring had largely comparable birth anthropometric characteristics to those exposed to insulin.</p

Supplementary information files for Relationships between exposure to gestational diabetes treatment and neonatal anthropometry: Evidence from the Born in Bradford (BiB)

© the authors, CC-BY NCSupplementary files for article Relationships between exposure to gestational diabetes treatment and neonatal anthropometry: Evidence from the Born in Bradford (BiB)Objectives To examine the relationships between gestational diabetes mellitus (GDM) treatment and neonatal anthropometry.Methods Covariate-adjusted multivariable linear regression analyses were used in 9,907 offspring of the Born in Bradford cohort. GDM treatment type (lifestyle changes advice only, lifestyle changes and insulin or lifestyle changes and metformin) was the exposure, offspring not exposed to GDM the control, and birth weight, head, mid-arm and abdominal circumference, and subscapular and triceps skinfold thickness the outcomes.Results Lower birth weight in offspring exposed to insulin (-117.2g (95% CI -173.8,-60.7)) and metformin (-200.3g (-328.5,-72.1)) than offspring not exposed to GDM was partly attributed to lower gestational age at birth and greater proportion of Pakistani mothers in the treatment groups. Higher subscapular skinfolds in offspring exposed to treatment compared to offspring not exposed to GDM was partly attributed to higher maternal glucose concentrations at diagnosis. In fully adjusted analyses, GDM treatment was associated with lower weight, smaller abdominal circumference and skinfolds at birth than offspring not exposed to GDM. Metformin was associated with smaller mid-arm circumference (-0.3cm (-0.6,-0.07)) than insulin in fully adjusted models with no other differences found.Conclusions for Practice Offspring exposed to GDM treatment were lighter and smaller at birth than offspring not exposed to GDM. Metformin-exposed offspring had largely comparable birth anthropometric characteristics to those exposed to insulin.</p

Associations between maternal characteristics and pharmaceutical treatment of gestational diabetes: an analysis of the UK Born in Bradford (BiB) cohort study

Objectives To identify the maternal characteristics associated with pharmaceutical treatment of gestational diabetes mellitus (GDM).Design Prospective birth cohort study.Setting Bradford, UK.Participants 762 women from the Born in Bradford (BiB) cohort who were treated for GDM in a singleton pregnancy. BiB cohort participants were recruited from 2007 to 2010. All women booked for delivery were screened for GDM between 26 and 28 weeks of gestation using a 75 g 2-hour oral glucose tolerance test (OGTT).Outcome measure GDM treatment type: lifestyle changes advice (lifestyle changes), lifestyle changes advice with supplementary insulin (insulin) and lifestyle changes advice with supplementary metformin (metformin).Results 244 (32%) women were prescribed lifestyle changes advice alone while 518 (68%) were offered supplemental pharmaceutical treatment. The odds of receiving pharmaceutical treatment relative to lifestyle changes advice alone were increased for mothers who were obese (OR 4.6, 95% CI 2.8 to 7.5), those who smoked (OR 2.6, 95% CI 1.2 to 5.5) and had higher fasting glucose levels at OGTT (OR 2.1, 95% CI 1.6 to 2.7). The odds of being prescribed pharmaceutical treatment rather than lifestyle changes advice were lower for Pakistani women (OR 0.7, 95% CI 0.4 to 1.0)) than White British women. Relative to insulin treatment, metformin was more likely to be offered to obese women than normal weight women (relative risk ratio, RRR 3.2, 95% CI 1.3 to 7.8) and less likely to be prescribed to women with higher fasting glucose concentrations at OGTT (RRR 0.3, 95% CI 0.2 to 0.6).Conclusions In the BiB cohort, GDM pharmaceutical treatment tended to be prescribed to women who were obese, White British, who smoked and had more severe hyperglycaemia. The characteristics of metformin-treated mothers differed from those of insulin-treated mothers as they were more likely to be obese but had lower glucose concentrations at diagnosis.</div

The Hypo-METRICS App: a mixed-methods investigation of content validity, acceptability, and feasibility in a 10-week study.

Background: The Hypo-METRICS smartphone app was developed to investigate the impact of hypoglycaemia on daily functioning in adults with type 1 diabetes (T1DM) or insulin-treated type 2 diabetes (T2DM). The app uses ecological momentary assessments, thereby minimising recall bias and maximising ecological validity. It was used in the Hypo-METRICS study, a European multi-centre observational study, wherein participants wore a blinded continuous glucose monitoring device and completed the app three times daily for 70 days. The three aims of the study were to explore: 1) the content validity of the app content, 2) the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and 3) suggestions for future versions of the app. Methods: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief online survey and an online interview (approximately one hour) to explore their experiences with the app during the Hypo-METRICS study. A thematic analysis of the qualitative data was conducted using both deductive and inductive methods. Results: Eighteen adults with diabetes (T1DM: n=10; 50% female, mean±SD age 47±16 years; T2DM: n=8, 25% female, mean±SD age 61±9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. Three themes were derived: 1) hypoglycaemia symptoms and experiences are idiosyncratic, 2) it was easy to select ratings on the app, but day-to-day changes are perceived as minimal and 3) instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, five themes were derived: 1) helping science and people with diabetes; 2) easy to fit in, but more flexibility wanted; 3) hypoglycaemia delaying responses and increasing completion time; 4) design, functionality, and customisability of the app and, 5) limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall, and as having a possible, although limited, intervention effect, in terms of both hypoglycaemia awareness and personal impact. Conclusions: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycaemia on an individual’s daily functioning. Despite suggested improvements, participants responses indicate that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, the real-time assessments may have clinical value for monitoring and review of hypoglycaemia symptom awareness and personal impact.Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and T1DM Exchange, JDRF, International Diabetes Federation (IDF) and The Leona M. and Harry B. Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. JS and CH are supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. GME’s position at King’s College London is funded by a grant from Novo Nordisk