Petit Cactus Study

NCT07380802 | Completed

• 1 other identifier: 24-05-011
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to test a newly developed carbohydrate counting mobile application (named Petit Cactus) with photo recognition, for people with type 1 diabetes. To evaluate Petit Cactus, our objectives are: 1. To measure the association between app engagement and changes in blood glucose management over the same period. 2. To assess the usability of the app, focusing on engagement (i.e., frequency of meal logs) over 3 months and user satisfaction. 3. To validate the nutritional data obtained from the app's photo recognition algorithm by comparing it with a validated nutrient intake method (in this case, a web-based 24h recall). Participants will submit their Ambulatory Glucose Profile (i.e., CGM data) at the beginning and at the end of 3 months, download the app to use for carbohydrate counting for the 3-month duration, complete a usability questionnaire at the end of 3 months, and complete an end-of-study interview to report on their satisfaction with the app.

Conditions

Type1diabetes

Keywords

Type1diabetes; Carbohydrate Counting; Usability; Glycemic Management; Mobile Application

Outcome Measures

Primary Outcomes (5)

• Time-in-Range

  Percentage of the time that glucose levels were within the recommended range (3.9 mmol/L and 10 mmol/L)

  At baseline and 3 months

• Estimated A1c

  Estimated glucose levels i.e., glucose management indicator (GMI)

  At baseline and at 3 months

• Engagement

  the frequency of meal logs in the app

  Throughout the 3 months

• System Usability System Scale

  System usability system (SUS) scale / 10 items) to assess how usable a system (the app) is, the higher the score (out of 100) the higher the usability.

  At 3 months

• Usability perception and experiences themes

  Thematic analysis of semi-structured interviews using an interview guide entered around the 10 items of the system usability scale

  At 3 months

Secondary Outcomes (1)

• Petit Cactus' nutrient analysis validation

  Five random days from baseline until the end of the 3-month trial

Study Arms (1)

Petit Cactus

EXPERIMENTAL

Access to "Petit Cactus" carbohydrate counting app to assist with meal logs for 3 months

Device: Petit Cactus

Interventions

Petit Cactus DEVICE

Access to the mobile application named Petit Cactus for 3 months to assist with carbohydrate counting in the context of type 1 diabetes using the following features: 1) Identify and log food items and estimate quantities through both photo recognition and manual selection from canadian food databases, 2) Automatically calculate and suggest the bolus insulin dose needed for a meal, based on the insulin-to-carbohydrate ratios entered in the settings and previously determined by the endocrinologist and healthcare team. 3) Track meals and different logged events (physical activity, stress levels, menstrual cycle...) and their impact on blood glucose levels.

Petit Cactus

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with T1D for at least 1 year on basal-bolus insulin regimen
• Uses a Continuous Glucose Monitoring (CGM) system
• Aged 14 years or older; 4. Residing in Canada
• Able to speak/understand French or English
• Uses carbohydrate counting as part of treatment regimen i.e., knows their insulin-to-carb ratio and correction factors.

You may not qualify if:

• \- Unable to use a smartphone with internet access

Sponsors & Collaborators

• McGill University: lead
• Laval University: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, H9X 3V9, Canada

Location

Related Publications (6)

• Housni A, Katz A, Bergeron LJ, Simard A, Finkel A, Roy-Fleming A, Nakhla M, Brazeau AS. Bridging the Gap in Carbohydrate Counting With a Mobile App: Needs Assessment Survey. J Med Internet Res. 2025 Mar 28;27:e63278. doi: 10.2196/63278.

  PMID: 40153793 RESULT

• Laramee C, Lemieux S, Robitaille J, Lamarche B. Comparing the Usability of the Web-Based 24-h Dietary Recall R24W and ASA24-Canada-2018 among French-Speaking Adults from Quebec. Nutrients. 2022 Oct 28;14(21):4543. doi: 10.3390/nu14214543.

  PMID: 36364803 RESULT

• Fu S, Li L, Deng S, Zan L, Liu Z. Effectiveness of advanced carbohydrate counting in type 1 diabetes mellitus: a systematic review and meta-analysis. Sci Rep. 2016 Nov 14;6:37067. doi: 10.1038/srep37067.

  PMID: 27841330 RESULT

• Fortin A, Rabasa-Lhoret R, Roy-Fleming A, Desjardins K, Brazeau AS, Ladouceur M, Gingras V. Practices, perceptions and expectations for carbohydrate counting in patients with type 1 diabetes - Results from an online survey. Diabetes Res Clin Pract. 2017 Apr;126:214-221. doi: 10.1016/j.diabres.2017.02.022. Epub 2017 Feb 22.

  PMID: 28273644 RESULT

• Ziegler R, Rees C, Jacobs N, Parkin CG, Lyden MR, Petersen B, Wagner RS. Frequent use of an automated bolus advisor improves glycemic control in pediatric patients treated with insulin pump therapy: results of the Bolus Advisor Benefit Evaluation (BABE) study. Pediatr Diabetes. 2016 Aug;17(5):311-8. doi: 10.1111/pedi.12290. Epub 2015 Jun 15.

  PMID: 26073672 RESULT

• Tascini G, Berioli MG, Cerquiglini L, Santi E, Mancini G, Rogari F, Toni G, Esposito S. Carbohydrate Counting in Children and Adolescents with Type 1 Diabetes. Nutrients. 2018 Jan 22;10(1):109. doi: 10.3390/nu10010109.

  PMID: 29361766 RESULT

Study Officials

• Anne-Sophie Brazeau, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Decentralized mixed-methods quasi-experimental trial with pre-post design

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: February 2, 2026
• Study Start: February 20, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 30, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)