scholarly journals The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029859
Author(s):  
Bettina Ewers ◽  
Tina Vilsbøll ◽  
Henrik Ullits Andersen ◽  
Jens Meldgaard Bruun
Keyword(s):  
Type 1 Diabetes ◽  
Glycaemic Control ◽  
Controlled Trial ◽  
Mean Amplitude ◽  
Study Groups ◽  
Estimation Accuracy ◽  
Haemoglobin A1c ◽  
Open Label ◽  
Carbohydrate Counting

IntroductionClinical guidelines recommend that patients with type 1 diabetes (T1D) learn carbohydrate counting or similar methods to improve glycaemic control. Although systematic educating in carbohydrate counting is still not offered as standard-of-care for all patients on multiple daily injections (MDI) insulin therapy in outpatient diabetes clinics in Denmark. This may be due to the lack of evidence as to which educational methods are the most effective for training patients in carbohydrate counting. The objective of this study is to compare the effect of two different educational programmes in carbohydrate counting with the usual dietary care on glycaemic control in patients with T1D.Methods and analysisThe study is designed as a randomised controlled trial with a parallel-group design. The total study duration is 12 months with data collection at baseline, 6 and 12 months. We plan to include 231 Danish adult patients with T1D. Participants will be randomised to one of three dietician-led interventions: (1) a programme in basic carbohydrate counting, (2) a programme in advanced carbohydrate counting including an automated bolus calculator or (3) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline to end of the intervention period (week 24) between and within each of the three study groups. Other outcome measures include changes in other parameters of plasma glucose variability (eg, 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 dietary management of 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 numberClinicalTrials.gov Registry (NCT03623113).

scholarly journals 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

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032893 ◽  
Author(s):  
Bettina Ewers ◽  
Jens Meldgaard Bruun ◽  
Tina Vilsbøll
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Glycaemic Control ◽  
Controlled Trial ◽  
Energy Restriction ◽  
Estimation Accuracy ◽  
Haemoglobin A1c ◽  
Open Label ◽  
Carbohydrate Counting

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 numberNCT03623139.

scholarly journals Metformin improves glycemic variability in adults with type 1 diabetes mellitus: an open-label randomized control trial

2021 ◽  
Author(s):  
Xiuzhen Zhang ◽  
Dan Xu ◽  
Ping Xu ◽  
Shufen Yang ◽  
Qingmei Zhang ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Insulin Dose ◽  
Glycemic Variability ◽  
Mean Amplitude ◽  
Insulin Requirement ◽  
Cvd Risk ◽  
Open Label ◽  
Metformin Therapy ◽  
Increased Risk

Introduction: Metformin has been demonstrated to enhance cardioprotective benefits in type 1 diabetes (T1DM). Although glycemic variability (GV) is associated with increased risk of CVD in diabetes, there is a scarcity of research evaluating the effect of metformin on GV in T1DM. Objectives: In the present study, the effects of adjuvant metformin therapy on GV and metabolic control in T1DM were explored. Patients and methods: A total of 65 adults with T1DM were enrolled and subjected to physical examination, fasting laboratory tests and continuous glucose monitoring, and subsequently randomized 1:1 to 3 months of 1000- 2000 mg metformin daily add-on insulin (MET group, n=34) or insulin (Non-MET group, n=31). After, baseline measurements were repeated. Results: The mean amplitude of glycemic excursions was substantially reduced in MET group, compared with Non-MET group [-1.58 (-3.35,0.31) mmol/L versus 1.36 (-1.12,2.24) mmol/L, P=0.004]. In parallel, the largest amplitude of glycemic excursions [-2.83 (-5.47,-0.06) mmol/L versus 0.45 (-1.29,4.48) mmol/L, P=0.004], the standard deviation of blood glucose [-0.85 (-1.51,0.01) mmol/L versus -0.14 (-0.68,1.21) mmol/L, P=0.015], and the coefficient of variation [-6.66 (-15.00,1.50) % versus -1.60 (-6.28,11.71) %, P=0.012] all demonstrated improvement in the MET group, compared with the Non-MET group. Significant reduction in insulin dose, body mass index and body weight were observed in patients in MET, not those in Non-MET group. Conclusion: Additional metformin therapy improved GV in adults with T1DM, as well as improving body composition and reducing insulin requirement. Hence, metformin as adjunctive therapy has potential prospects in reducing the CVD risk in patients with T1DM in the long term.

scholarly journals Carbohydrate Counting App Using Image Recognition for Youth With Type 1 Diabetes: Pilot Randomized Control Trial

10.2196/22074 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e22074
Author(s):  
Jeffrey E Alfonsi ◽  
Elizabeth E Y Choi ◽  
Taha Arshad ◽  
Stacie-Ann S Sammott ◽  
Vanita Pais ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetes Management ◽  
Digital Health ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Mobile App ◽  
Thinking Aloud ◽  
Carbohydrate Counting ◽  
Scale Scores

Background Carbohydrate counting is an important component of diabetes management, but it is challenging, often performed inaccurately, and can be a barrier to optimal diabetes management. iSpy is a novel mobile app that leverages machine learning to allow food identification through images and that was designed to assist youth with type 1 diabetes in counting carbohydrates. Objective Our objective was to test the app's usability and potential impact on carbohydrate counting accuracy. Methods Iterative usability testing (3 cycles) was conducted involving a total of 16 individuals aged 8.5-17.0 years with type 1 diabetes. Participants were provided a mobile device and asked to complete tasks using iSpy app features while thinking aloud. Errors were noted, acceptability was assessed, and refinement and retesting were performed across cycles. Subsequently, iSpy was evaluated in a pilot randomized controlled trial with 22 iSpy users and 22 usual care controls aged 10-17 years. Primary outcome was change in carbohydrate counting ability over 3 months. Secondary outcomes included levels of engagement and acceptability. Change in HbA1c level was also assessed. Results Use of iSpy was associated with improved carbohydrate counting accuracy (total grams per meal, P=.008), reduced frequency of individual counting errors greater than 10 g (P=.047), and lower HbA1c levels (P=.03). Qualitative interviews and acceptability scale scores were positive. No major technical challenges were identified. Moreover, 43% (9/21) of iSpy participants were still engaged, with usage at least once every 2 weeks, at the end of the study. Conclusions Our results provide evidence of efficacy and high acceptability of a novel carbohydrate counting app, supporting the advancement of digital health apps for diabetes care among youth with type 1 diabetes. Further testing is needed, but iSpy may be a useful adjunct to traditional diabetes management. Trial Registration ClinicalTrials.gov NCT04354142; https://clinicaltrials.gov/ct2/show/NCT04354142

scholarly journals The Association between the Parents’ Knowledge of Carbohydrate Counting and the Glycaemic Control of the Children with Type 1 Diabetes

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Priyanga Ranasinghe ◽  
Vidarsha Rajini Senadeera ◽  
Rashmi Senarathna ◽  
Uththara Sapurnika ◽  
Vindhya Ramanayake ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycaemic Control ◽  
Carbohydrate Content ◽  
Accurate Estimation ◽  
Inverse Association ◽  
Total Carbohydrate ◽  
Cross Sectional ◽  
Carbohydrate Counting ◽  
Duration Of Diabetes

Background. Medical nutritional therapy is an important component of type 1 diabetes (T1D) care in children and carbohydrate counting is one such method. We aimed to evaluate the knowledge of carbohydrate counting among parents of children with T1D from Sri Lanka and study its association with the child’s glycaemic control. Methods. A descriptive cross-sectional study was conducted among parents of children with T1D. HbA1c measurement was used to assess glycaemic control. Knowledge of parent regarding carbohydrate counting was assessed based on a 24-hour dietary recall. Carbohydrate counting knowledge was defined using ratio of carbohydrate content estimated by parents to actual carbohydrate content calculated by researchers (Total, Breakfast, Lunch, Dinner, and Snacks). Ratios obtained were also divided into three groups, underestimation (<0.9), accurate estimation (0.9-1.1), and overestimation (>1.1). A multivariate regression analysis was performed to determine contribution of carbohydrate counting accuracy to glycaemic control (HbA1c). Results. Sample size was 181 and mean age of the parents was 38.8±5.9 years. Mean duration of diabetes in the children was 3.7±2.6 years and mean HbA1c level was 8.3±0.9%. On average, parents estimates of carbohydrate count for the total meal were 0.88±0.27 (88%) (range 0.38-1.47) of the actual carbohydrate count. Only 30.5% (n=55) of parents were grouped in the “accurate” estimation category for the total carbohydrate count. Parents of children with diabetes for ≤3 years estimated total carbohydrate count more accurately than the counterparts (p<0.05). Mean HbA1c value of those who “underestimated” was significantly higher than those with “accurate” estimation. In the multivariate analysis accuracy of carbohydrate estimation was associated with a lower HbA1c (β = −0.36; p=0.03). Conclusions. Overall knowledge of carbohydrate counting among parents was inadequate. Better knowledge was associated with improved glycaemic control in children and lower incidence of hypoglycaemic episodes. An inverse association was observed between knowledge and duration of diabetes.

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