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

T

The Hospital for Sick Children

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: iSpy

Study type

Interventional

Funder types

Other

Identifiers

NCT04354142
1000054297

Details and patient eligibility

About

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.

Full description

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.

Enrollment

46 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

iSpy
Experimental group
Description:
In addition to usual care, participants in the intervention group will receive the iSpy intervention.
Treatment:
Device: iSpy
Control
No Intervention group
Description:
The control group participants will continue to use their usual method of carbohydrate counting for a 3-month period.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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