A Novel Carbohydrate Counting Smartphone App for Youth With Type 1 Diabetes

NCT04354142 | Completed

• 1 other identifier: 1000054297
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Carbohydrate (CHO) Counting Accuracy

  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.

  3 months

• Carbohydrate (CHO) Counting Efficiency (Time to count)

  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.

  3 months

Secondary Outcomes (7)

• Change in Quality of Life: Self Care Inventory Questionnaire

  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: Global Quality of Life

  3 months

• Implementation outcomes: Accrual/Attrition Rates

  3 months

Study Arms (2)

iSpy

EXPERIMENTAL

In addition to usual care, participants in the intervention group will receive the iSpy intervention.

Device: iSpy

Control

NO INTERVENTION

The control group participants will continue to use their usual method of carbohydrate counting for a 3-month period.

Interventions

iSpy DEVICE

iSpy is a novel healthcare application that hopes to address 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.

iSpy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Alfonsi JE, Choi EEY, Arshad T, Sammott SS, Pais V, Nguyen C, Maguire BR, Stinson JN, Palmert MR. Carbohydrate Counting App Using Image Recognition for Youth With Type 1 Diabetes: Pilot Randomized Control Trial. JMIR Mhealth Uhealth. 2020 Oct 28;8(10):e22074. doi: 10.2196/22074.

  PMID: 33112249 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark Palmert

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chair of Pediatrics

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 21, 2020
• Study Start: July 12, 2018
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)