Clinical Application of the Food Insulin Index for Mealtime Insulin Dosing in Adults with Type 1 Diabetes: A Randomized Controlled Trial

Bell, Kirstine J.; Gray, Robyn; Munns, Diane; Petocz, Peter; Steil, Garry M.; Howard, G.; Colagiuri, Stephen; Brand-Miller, Jennie

doi:10.1089/dia.2015.0254

Cited by 20 publications

(31 citation statements)

References 16 publications

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“…100 Its clinical applicability has been investigated in a randomized pilot trial in adults, which demonstrated no significant difference in glycemic outcomes compared to carbohydrate counting. 101 The Food Insulin Index has also been compared to carbohydrate counting in dosing for protein-only foods in a small acute postprandial study in adults. 102 • Twice daily insulin regimens of short and longer acting insulin require day-to-day consistency in carbohydrate intake (often as three regular meals with snacks between) to balance the insulin action profile and prevent hypoglycemia during periods of peak insulin action.…”

Section: Fat and Proteinmentioning

confidence: 99%

“…Another novel insulin dosing algorithm based on the Food Insulin Index (FII), has also been developed and trialed in adults . Its clinical applicability has been investigated in a randomized pilot trial in adults, which demonstrated no significant difference in glycemic outcomes compared to carbohydrate counting . The Food Insulin Index has also been compared to carbohydrate counting in dosing for protein‐only foods in a small acute postprandial study in adults .…”

Section: Introductionmentioning

confidence: 99%

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ISPAD Clinical Practice Consensus Guidelines 2018: Nutritional management in children and adolescents with diabetes

et al. 2018

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Section: Fat and Proteinmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

ISPAD Clinical Practice Consensus Guidelines 2018: Nutritional management in children and adolescents with diabetes

et al. 2018

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“…The protocol for this study was written and implemented prior to the global consensus guidelines . This study uses a higher threshold for vitamin D deficiency, which is consistent with other published guidelines …”

Section: Methodsmentioning

confidence: 94%

“…A global consensus statement on the treatment of nutritional rickets recommended a daily vitamin D dose in children older than 2 years of age of 3000–6000 IU/day, with calcium supplementation to correct 25OHD deficiency and treat rickets . The American Academy of Paediatrics suggests treating 25OHD deficiency in children >12 months of age with vitamin D therapy of 5000 IU per day for 2–3 months .…”

mentioning

confidence: 99%

Safety and effectiveness of stoss therapy in children with vitamin D deficiency

Tannous

Fiscaletti

Wood

et al. 2019

J Paediatrics Child Health

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Aim Paediatric vitamin D (25‐hydroxyvitamin D (25OHD)) deficiency can lead to nutritional rickets and extra‐skeletal complications. Compliance with daily therapy can be difficult, making high‐dose, short‐term vitamin D (stoss) therapy attractive to correct vitamin D deficiency. We compared the effectiveness and safety of standard versus stoss therapy in treating childhood 25OHD deficiency. Methods Children aged 2–16 years with 25OHD <50 nmol/L were randomised to either standard (5000 IU daily for 80 days) or stoss (100 000 IU weekly for 4 weeks) cholecalciferol. Participants underwent an evaluation of effectiveness and safety. The 25OHD level, random spot calcium: creatinine ratio (Ca:Cr) and compliance were measured at 12 weeks. Results A total of 151 children were enrolled in the study (68 standard and 83 stoss), median age 9 years (inter‐quartile range (IQR): 6–12 years). Baseline 25OHD levels were 26 nmol/L (IQR: 19–35 nmol/L) and 32 nmol/L (IQR: 24–39 nmol/L) in the standard and stoss groups, respectively. At 12 weeks, the median 25OHD level was significantly greater in the standard versus stoss group (81 vs. 67 nmol/L; P = 0.005); however, >80% of participants in both groups achieved sufficiency (25OHD > 50 nmol/L) and had normal urinary Ca:Cr, with no significant difference seen between groups. Compliance was similar in the two groups. Conclusions Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, in both groups, there was a similar proportion of participants who achieved 25OHD sufficiency, with no evidence of toxicity. Unlike other studies, simplifying the treatment regimen did not improve compliance. These results support stoss therapy as an effective and safe alternative therapy for the treatment of paediatric vitamin D deficiency.

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“…The used SD and dropout rate were based on previous BCC courses at SDCC where mean changes and SD of HbA1c after 6 months were calculated based on completers with T2D. MAGE has only been used as an outcome measure of glucose variability in a few randomised controlled dietary intervention studies of people with diabetes,37 38 showing differences in changes in MAGE up to 4.8 mmol/L (SD 1.0) after a 12-week carbohydrate counting intervention,37 but is regularly used in other clinical studies evaluating glucose variability. By including 113 participants in each study group, we will have a power of 80% (alpha level of 0.05) in a two-sided test to detect a difference in the change in MAGE during the intervention period (6 months) of ≥0.30 mmol/L (SD 0.7 mmol/L) between the two study groups.…”

Section: Aimmentioning

confidence: 99%

Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes

2019

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IntroductionRecommendations on energy intake are key in body weight management to improve glycaemic control in people with type 2 diabetes (T2D). International clinical guidelines recommend a variety of eating patterns to promote energy restriction as the primary dietetic approach to body weight control in managing T2D. In addition, individualised guidance on self-monitoring carbohydrate intake to optimise meal timing and food choices (eg, basic carbohydrate counting (BCC)) is recommended to achieve glycaemic control. However, the evidence for this approach in T2D is limited. The objective of this study was to compare the effect of an educational programme in BCC as add-on to the usual dietary care on glycaemic control in people with T2D.Methods and analysesThe study is designed as a randomised, controlled trial with a parallel-group design. The study duration is 12 months with data collection at baseline, and after 6 and 12 months. We plan to include 226 adults with T2D. Participants will be randomised to one of two interventions: (1) BCC as add-on to usual dietary care or (2) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups. Further outcome measures include changes in time in range, body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in diet and diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers.Ethics and disseminationThe protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration number NCT03623139.

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Clinical Application of the Food Insulin Index for Mealtime Insulin Dosing in Adults with Type 1 Diabetes: A Randomized Controlled Trial

Abstract: In a 12-week pilot study, MAGE and postprandial glycemia following breakfast were significantly improved with FII counting versus CC, despite no significant differences in HbA1c.

Cited by 20 publications

References 16 publications

ISPAD Clinical Practice Consensus Guidelines 2018: Nutritional management in children and adolescents with diabetes

ISPAD Clinical Practice Consensus Guidelines 2018: Nutritional management in children and adolescents with diabetes

Safety and effectiveness of stoss therapy in children with vitamin D deficiency

Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes

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