Supporting Meal Management in Type 1 Diabetes

NCT05671679 | Completed

• 1 other identifier: SUMMIT1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Carbohydrate count marks the cornerstone of Type 1 Diabetes management. Eventhough it is a crucial task, it is burdensome and prone to error. Therefore, the investigators want to explore the effect that SNAQ, a food analyser app would have in glycaemic control by facilitating the task of carbohydrate estimation.

Conditions

Type 1 Diabetes

Keywords

Carbohydrates; Continuous glucose measurement; Closed-loop systems; Type 1 Diabetes; Hyperglycaemia; Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Percentage of time with sensor glucose in the target range

  Percentage of time with sensor glucose in the target range between 3.9 to 10.0mmol/L, %

  3-week intervention period (Day 1 to Day 21)

Secondary Outcomes (5)

• Percentage of time with sensor glucose in hyperglycaemia

  3-week intervention period (Day 1 to Day 21)

• Percentage of time with sensor glucose in hypoglycaemia

  3-week intervention period (Day 1 to Day 21)

• Percentage of postprandial time with sensor glucose in target range

  3-week intervention period (Day 1 to Day 21)

• Percentage of postprandial time with sensor glucose in hyperglycaemia

  3-week intervention period (Day 1 to Day 21)

• Percentage of postprandial time with sensor glucose in hypoglycaemia

  3-week intervention period (Day 1 to Day 21)

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will use SNAQ app for the first 3 weeks (baseline to V1) of the study.

Other: SNAQ app

Control

ACTIVE COMPARATOR

The control group will continue estimating the carbohydrate count using their traditional methods for the first three weeks of the study (baseline to V1).

Other: Traditional carbohydrate counting

Interventions

SNAQ app OTHER

SNAQ is a smartphone food analysis app that estimates the macronutrient content of a meal, based on a single image. The app first determines meal content in terms of food components with input from the user to correct or add further components (e.g. foods, ingredients, sauces, herbs or seasonings). Then, the total macronutrient and energy content of the meal is determined based on the estimated volume and information from a nutritional database. Of note, the application also allows for assessing nutritional content of packaged foods by means of a barcode scanning function. The user can always adapt proposed nutritional contents at their own discretion. Meal macronutrients alongside the food pictures are collected in a detailed log which allows users to review their dietary choices. The product is not conceived by its manufacturer to be used for medical purposes and can thus not be considered a medical device.

Intervention

Traditional carbohydrate counting OTHER

Patients will follow their traditional methods of carbohydrate counting during the control period. In addition to assess sustainability of the intervention, following the control period, the control group will also go an intervention period of 3 weeks using the SNAQ App.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Adults (aged 18 years or older)
• Type 1 diabetes (as defined by World Health Organization (WHO) for at least 12 month)
• Current use of a commercial hybrid closed-loop system
• HbA1c≤12% (measured within the past 3 months)
• Willing to use the SNAQ app on a daily basis for over 3 weeks
• The participant is willing to follow study specific instructions and share their treatment data with the study team

You may not qualify if:

• Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
• Previous use of SNAQ app for more than 5 days within the past 3 months
• Self-reported pregnancy, planed pregnancy within next 3 months or breast-feeding
• Severe visual impairment
• Severe hearing impairment
• Lack of reliable telephone facility for contact
• Concomitant participation in another trial that interferes with the normal conduct of the study and interpretation of the study results
• Participant not proficient in German

Sponsors & Collaborators

• Lia Bally: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Lia Bally, MD PhD

  UDEM Inselspital, University Hospital of Berne, and University Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research and Head of Nutrition, Metabolism and Obesity

Model Details: The study will follow a randomized two-arm parallel design. Study visits will be done remotely via video calls or in-clinic when coinciding with usual care appointments. Following a baseline visit and before randomization, baseline characteristics and medical history of the participants will be collected (as detailed in section 4.3). Following randomization, the intervention group will use SNAQ app for the first 3 weeks while the control group will proceed without any modification/intervention by the study team. After the first 3 weeks, the control group will undergo 3 weeks of SNAQ app use (weeks 4-6). At the end of their respective SNAQ app periods (weeks 4-6 for the intervention group and weeks 7-9 for the control group), both groups will discontinue the use of SNAQ app for 3 weeks to assess sustainability of potential effects. Finally, both groups will be offered to use SNAQ app for 3 additional weeks as per their preference (follow-up period).

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 5, 2023
• Study Start: March 27, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the study results in a peer-reviewed journal.
• Access Criteria: Contact with an approval by the corresponding author.

Locations

CH (1)