Defining relevant hypoglycemia measures in children and adolescents with type 1 diabetes

Jones, Timothy W.

doi:10.1111/pedi.12600

Cited by 14 publications

(14 citation statements)

References 21 publications

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“…Duration of hypoglycemia was reported for all youth, regardless of whether they experienced a 15‐minute episode of hypoglycemia, as defined previously. These measures are consistent with recent position statements on hypoglycemia by the International Society of Pediatric and Adolescent Diabetes Hypoglycemia Guidelines Writing Group …”

Section: Methodssupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

“…Recently, the International Hypoglycemia Study Group (IHSG) standardized definitions of hypoglycemia . Prior to the use of continuous glucose monitors (CGMs) that provide glucose values every 5 to 15 minutes, episodes of non‐severe hypoglycemia (<70 mg/dL, but not associated with severe cognitive impairment requiring external assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions) were not thoroughly captured in outpatient settings . To date, the majority of CGM data on hypoglycemia in adolescents with type 1 diabetes have come from diabetes technology clinical trials where study criteria excluded participants with elevated HbA1c levels (typically ≥9.0 or 10.0%), resulting in study samples with mean HbA1c levels <9.0%, and typically ranging from 7.0% to 8.6% .…”

Section: Introductionmentioning

confidence: 99%

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Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in The Flexible Lifestyle Empowering Change (FLEX) trial

et al. 2018

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Objective: To examine the prevalence and correlates of non-severe hypoglycemia among adolescents with type 1 diabetes and suboptimal glycemic control, an understudied topic in this group. Methods: Seven days of blinded continuous glucose monitor data were analyzed in 233 adolescents at baseline of the Flexible Lifestyle Empowering Change trial (13-16 years, type 1 diabetes duration >1 year, and hemoglobin A1c [HbA1c] 8-13% [64-119 mmol]). Incidence of clinical hypoglycemia (54-69 mg/dL) and clinically serious hypoglycemia (<54 mg/dL) was defined as number of episodes ≥15 minutes. Logistic regression modeling was used to determine the correlates of long duration of hypoglycemia, categorized by median split among those who experienced hypoglycemia. Results: The sample was 76.1% non-Hispanic white, 49.8% female, age = 14.9 AE 1.1 years, diabetes duration = 6.4 AE 3.7 years, and HbA1c = 9.6 AE 1.2% (81 AE 13 mmol/mol). Over 7 days, 79.4% of youth experienced ≥1 hypoglycemic episodes of <70 mg/dL, and 55.4% of youth experienced ≥1 hypoglycemic episodes of <54 mg/dL. Among all adolescents, the median duration of clinical hypoglycemia and clinically serious hypoglycemia was 21.9 (range 0-250.2) and 4.3 (range 0-209.7) minutes/day, respectively. Long duration of clinical hypoglycemia (range 1.8-17.4% time overall) and clinically serious hypoglycemia (range 1.2-14.6% time overall) was associated with older age and decreasing HbA1c. Long duration of clinically serious hypoglycemia also was associated with insulin pump use.Conclusions: Almost 80% of adolescents with elevated HbA1c had an episode of clinical hypoglycemia, and >50% had clinically serious hypoglycemia in a week. Increased education alongside access to emerging diabetes technologies may help to prevent hypoglycemia while improving glycemic control. K E Y W O R D Sblood glucose, diabetes mellitus, type 1, glycated hemoglobin A, hypoglycemia

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Section: Methodssupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in The Flexible Lifestyle Empowering Change (FLEX) trial

et al. 2018

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“…We used standardized definitions of hypoglycemia set forth by position statements of the International Hypoglycemia Study Group from the International Society of Pediatric and Adolescent Diabetes. 23,28,29 The primary exposure was hypoglycemia categorized as a three-level…”

Section: Exposuresmentioning

confidence: 99%

Dietary intake on days with and without hypoglycemia in youth with type 1 diabetes: The Flexible Lifestyle Empowering Change trial

et al. 2020

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Objective: To address a common perception that hypoglycemia is associated with increased dietary intake, we examined calorie and carbohydrate consumption on days with and without hypoglycemia among adolescents with type 1 diabetes (T1D). Methods: Days (N = 274) with 24-hour dietary recalls and continuous glucose monitoring were available for 122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13-16 years, diabetes duration >1 year, hemoglobin A1c 8%-13%). Days with no hypoglycemia, clinical hypoglycemia (54-69 mg/dL) or clinically serious hypoglycemia (<54 mg/dL) were further split into night (12-5:59 AM) and day (6 AM-11:59 PM). Mixed models tested whether intake of calories or carbohydrates was greater on days with than without hypoglycemia. Results: Fifty-nine percent, 23% and 18% of days had no hypoglycemia, clinical hypoglycemia and clinically serious hypoglycemia, respectively. Intake of calories and carbohydrates was not statistically significantly different on days with clinical hypoglycemia (57.2 kcal [95% CI-126.7, 241.5]; 12.6 g carbohydrate [95% CI-12.7, 38.0]) or clinically serious hypoglycemia (−74.0 kcal [95% CI-285.9, 137.9]; (−7.8 g carbohydrate [95% CI-36.8, 21.1]), compared to days without hypoglycemia. Differences by day and night were not statistically significant. Conclusions: Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia. It is possible that hypoglycemic episodes caused by undereating relative to insulin dosing, followed by overeating, leading to a net neutral difference. Given the post-hoc nature of these analyses, larger studies should be designed to prospectively test the hypoglycemiadiet relationship.

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“…In addition, secondary outcome variables will be number of all hypoglycemic episodes (blood glucose < 70 mg/dL (3.9 mmol/L) and ketoacidosis episodes (hyperglycemia blood glucose > 11 mmol/L, venous pH < 7.3, or serum bicarbonate < 15 mmol/L, ketonemia blood ßhydroxybuyrate ≥ 3 mmol/L), taken as a composite variable at baseline and 3 and 6 months [30][31][32]. Total number of abnormal episodes counted over the followup period will be considered as a composite outcome.…”

Section: Outcome Measuresmentioning

confidence: 99%

Lifestyle changes and glycemic control in type 1 diabetes mellitus: a trial protocol with factorial design approach

Sawani

Siddiqui

Azam

et al. 2020

Trials

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Background: Type 1 diabetes (T1D) has been increasing globally over the past three decades. Self-monitoring of blood glucose is a challenge in both developed as well as developing countries. Self-management guidelines include maintaining logbooks for blood glucose, physical activity, and dietary intake that affect glycated hemoglobin (HbA1c) and a multitude of life-threatening acute complications. Innovative, cost-effective interventions along with beneficial lifestyle modifications can improve home-based self-monitoring of blood glucose in T1D patients. The overall objective of this study is to evaluate the relationship between maintaining log books for blood glucose levels, reinforcement by e-messages, and/or daily step count and changes in HbA1c. Methods/design: A randomized controlled trial will enroll participants aged 15 years and above in four groups. Each group of 30 participants will be working with a newly designed standard log book for documenting their blood glucose. The first group will be entirely on routine clinical care, the second group will be on routine care and will receive an additional e-device for recording step count (fit bit), the third group will receive routine care and daily motivational e-messages to maintain the log book, and the fourth group along with routine care will receive an e-device for measuring step count (fit bit) and e-messages about maintaining the log book. Patients will be enrolled from pediatric and endocrine clinics of a tertiary care hospital in Karachi. All groups will be followed up for a period of 6 months to evaluate outcomes. Log book data will be obtained every 3 months electronically or during a patient's clinic visit. HbA1c as a main outcome will be measured at baseline and will be evaluated twice every 3 months. A baseline questionnaire will determine the socio-demographic, nutritional, and physical activity profile of patients. Clinical information for T1D and other co-morbidities for age of onset, duration, complications, hospitalizations, habits for managing T1D, and other lifestyle characteristics will be ascertained. Behavioral modifications for maintaining daily log books as a routine, following e-messages alone, fit bit alone, or e-messages plus using fit bit will be assessed for changes in HbA1c using a generalized estimated equation. Discussion: The proposed interventions will help identify whether maintaining log books for blood glucose, motivational e-messages, and/or daily step count will reduce HbA1c levels. Trial registration: ClinicalTrials.gov, NCT03864991. March 6, 2019.

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Defining relevant hypoglycemia measures in children and adolescents with type 1 diabetes

Cited by 14 publications

References 21 publications

Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in The Flexible Lifestyle Empowering Change (FLEX) trial

Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in The Flexible Lifestyle Empowering Change (FLEX) trial

Dietary intake on days with and without hypoglycemia in youth with type 1 diabetes: The Flexible Lifestyle Empowering Change trial

Lifestyle changes and glycemic control in type 1 diabetes mellitus: a trial protocol with factorial design approach

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