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Diabetes Mellitus, Type 1NCT04354142

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

A study testing iSpy in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
iSpy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteCanada
Study dates
12 Jul 2018to 27 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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;

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: iSpy: A Pilot Randomized Control Trial of a Novel Carbohydrate Counting Smartphone App for Youth With Type 1 Diabetes

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.

Read the detailed 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.

Being tested
iSpy
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iSpyDevice

    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.

Study groups in NCT04354142
Study groupRoleWhat they receive
iSpyExperimentalIn addition to usual care, participants in the intervention group will receive the iSpy intervention.
Receives: Device: iSpy
ControlNo interventionThe control group participants will continue to use their usual method of carbohydrate counting for a 3-month period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Secondary outcomes (7)

  1. Change in Quality of Life: Self Care Inventory Questionnaire

    Quality of Life questionnaires will be analyzed for any change from baseline to 3-month follow-up within both the intervention and control groups.

    The first questionnaire including:

    • Self Care Inventory: Scale from 1 (Never do it) to 5 (Always do this as recommended without fail);

    Measured: 3 months

  2. Change in Quality of Life: Diabetes Questionnaire

    Quality of Life questionnaires will be analyzed for any change from baseline to 3-month follow-up within both the intervention and control groups.

    The second questionnaire including:

    • Diabetes Family Responsibility Questionnaire: Selection of 1 of 3 statements best describing the way each task is handled in the family from 1 (Parent taking responsibility almost all of the time) 2 (Parent and Child sharing responsibility equally) to 3 (Child taking responsibility almost all of the time);

    Measured: 3 months

  3. Change in Quality of Life: Quality of Life for Youth

    Quality of Life questionnaires will be analyzed for any change from baseline to 3-month follow-up within both the intervention and control groups.

    The third questionnaire including:

    • Quality of Life for Youth: Scale from 0 (Never) to 4 (All the time);

    Measured: 3 months

  4. Change in Quality of Life: Global Quality of Life

    Quality of Life questionnaires will be analyzed for any change from baseline to 3-month follow-up within both the intervention and control groups.

    The last questionnaire including:

    • Global Quality of Life: Scale from 1 (No Change) to 7 (A great deal better);

    Measured: 3 months

  5. Implementation outcomes: Accrual/Attrition Rates

    • Criteria for implementation success will be based on the studies previously conducted by Co-Principal Investigator (JS): Participant accrual (total completed / total enrolled) and attrition rates (total dropouts / total enrolled). Success being defined as accrual rates >70% and attrition rates <15%;

    Measured: 3 months

  6. Implementation outcomes: Engagement

    • Levels of engagement will be assessed as follows:
    • Low: defined as less than 1 logged meal every 2 weeks
    • High: defined as greater than 1 logged meal every 2 weeks.

    Measured: 3 months

  7. Implementation outcomes: Acceptability

    • Acceptability: 7 item Acceptability e-Scale (AES) regarding level of acceptability from a scale of 1 (low) to 5 (high) of iSpy, with high acceptability being item mean score of 4 on AES. 2 additional qualitative items are included in AES and will be evaluated.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start12 Jul 2018
  3. Primary completion27 Jan 2020
  4. Study completion27 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354142
Sponsor's protocol ID
1000054297
Status last verified
Apr 2020
First submitted
10 Apr 2020
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33112249

Questions about this trial

What is this clinical trial studying?

A study testing iSpy in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carbohydrate (CHO) Counting Accuracy (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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