iSpy: A Pilot Randomized Control Trial of a Novel Carbohydrate Counting Smartphone App for Youth With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Carbohydrate (CHO) Counting Accuracy
研究概览
简要总结
Type 1 Diabetes Mellitus (T1DM) is a common chronic disease of childhood. T1DM has substantial impact on quality of life (QOL), including burdensome dietary restrictions and the need to count carbohydrates in foods to safely dose insulin. Carbohydrate counting is challenging, inconvenient, and, if done wrong, can cause high or low blood glucose levels.
To address these challenges, iSpy, a novel smartphone application, was created to identify foods and determine their carbohydrate content using pictures or speech. This pilot study is to evaluate if using iSpy improves carbohydrate counting accuracy and efficiency. Pilot participants will have carbohydrate counting (accuracy and efficiency) and their overall QoL (with respect to carbohydrate counting) assessed at baseline and after 3-months.
The investigators hypothesize that using iSpy will make carbohydrate counting easier (by improving accuracy and efficiency) and enhance QoL for patients and/or their caregivers. If so, iSpy may help lessen the burden of living with T1DM.
详细描述
Nutrition is an integral component of management of many chronic diseases and of overall wellness. Helping individuals to understand what they are eating can empower them to better manage their diseases. For example, the growing number of youth living with Type 1 Diabetes Mellitus (T1DM) struggle with carbohydrate counting, an essential and daily aspect of their lives, because of required reliance on memorization and numeracy skills. Effective carbohydrate counting has been demonstrated to improve blood glucose control, while inaccurate carbohydrate counting results in more variable blood glucose. Concerns related to carbohydrate counting accuracy can also limit food choices, provoke anxiety, and decrease quality of life. Since there is no cure for T1DM, enhancing patients' ability to understand and apply carbohydrate counting is an important part in helping them manage their condition most effectively.
iSpy is a novel healthcare application that addresses an important clinical need by facilitating carbohydrate counting using pictures or voice recognition. Proprietary algorithms adjust for portion size and identify hidden carbohydrates (such as in ketchup or other condiments) and quantify the amount of carbohydrates in a meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T1DM for ≥6 months;
- •Completion of initial carbohydrate counting classes;
- •Incorporating carbohydrate counting into treatment regimen;
- •Having access to a smart phone and data plan;
排除标准
- •Cognitive impairments or co-morbid physical or psychiatric condition (e.g. blindness, clinical depression, anxiety disorder) that might impact ability to use iSpy;
- •Diagnosis of condition that affects dietary exposure (e.g. celiac disease);
- •Participation in usability study;
结局指标
主要结局
Carbohydrate (CHO) Counting Accuracy
时间窗: 3 months
Assessing CHO counting using 10 food items from all major food groups. For each group, a simple food (e.g. an apple) and complex food (e.g. food with 2+ components but base food from targeted group) is included. A Co-investigator, Registered Dietitian (RD)/Certified Diabetes Educator (CDE), selected 2 sets of 10 food items for the study visits (verified that both sets were similar difficulty). The net CHO value (true value) for each food will be based on the nutrition label, USDA Nutrient Database (Release 28), Canadian Nutrient File, or by RD/CDE. For each food, data will be obtained from all participants: • Estimated net CHO (in grams) And with the above data, the following will be calculated: * % of food for which subjects estimated the CHO content within (+/-) 10 grams of true value. * Change (%) in the above accuracy measure for counting at baseline versus 3-month follow-up visit in iSpy vs control groups.
Carbohydrate (CHO) Counting Efficiency (Time to count)
时间窗: 3 months
Assessing CHO counting using 10 food items from all major food groups. For each group, a simple food (e.g. an apple) and complex food (e.g. food with 2+ components but base food from targeted group) is included. A Co-investigator, Registered Dietitian (RD)/Certified Diabetes Educator (CDE), selected 2 sets of 10 food items for the study visits (verified that both sets were similar difficulty). The net CHO value (true value) for each food will be based on the nutrition label, USDA Nutrient Database (Release 28), Canadian Nutrient File, or by RD/CDE. For each food, data will be obtained from all participants: • Time required to estimate net CHO (in seconds) In order to calculate the following: • Change in the above time taken for counting at baseline versus 3-month follow-up visit in iSpy vs control groups.
次要结局
- Implementation outcomes: Engagement(3 months)
- Change in Quality of Life: Global Quality of Life(3 months)
- Implementation outcomes: Acceptability(3 months)
- Change in Quality of Life: Diabetes Questionnaire(3 months)
- Change in Quality of Life: Quality of Life for Youth(3 months)
- Change in Quality of Life: Self Care Inventory Questionnaire(3 months)
- Implementation outcomes: Accrual/Attrition Rates(3 months)
研究者
Mark Palmert
Associate Chair of Pediatrics
The Hospital for Sick Children