Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05671679
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-12-22
Brief Title:
Supporting Meal Management in Type 1 Diabetes
Sponsor:
Lia Bally
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Supporting Meal Management in Type 1 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUMMIT1
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
Detailed Description:
Diet and physical activity are critically important in the lifestyle of people with type 1 diabetes When diagnosed with the disease people with type 1 diabetes are educated about nutritional goals and how to estimate nutritional content of food Carbohydrates are the food component with the greatest impact on blood glucose levels and typical sources in the diet include starches some vegetables fruits dairy products and sugars Thus people with type 1 diabetes are primarily being trained to estimate the carbohydrate content of food a task that is also referred to as carbohydrate counting Different methods can be used to count carbohydrate in food and drink These include reading the nutritional labels consulting reference books or websites carrying a database on a personal digital assistant or using exchange tables which provides the carbohydrate content for typical serving sizes eg 1 slice of bread While nutritional information can be accessed through the above mentioned methods the quantification of the portion sizes if not indicated on the food package requires the additional use of scale or measuring vessel Given the required effort and time investment related to these methods the great majority of people with type 1 diabetes count carbohydrates by visual estimation and experience As a consequence peoples estimate often deviate substantially from ground truth values and average carbohydrate estimation errors reported in the literature are 20 or higher
Of note more than 60 of individuals with diabetes report having trouble with carbohydrate counting despite their awareness on its importance Even in patients who are confident in applying carbohydrate counting the daily task is perceived as major burden of diabetes self-management
Since carbohydrate counting is particularly demanding when eating fresh non-packaged foods a concerning trend towards unhealthy dietary choices with preference of prepackaged foods with accessible nutrition facts over whole foods is increasingly observed in people with type 1 diabetes This is paralleled by an increasing prevalence of overweight and obesity in the type 1 diabetes population
Thus even with the latest hybrid closed-loop insulin delivery technologies adequate nutrition knowledge remains a cornerstone for satisfactory glucose control metabolic health and prevention of diabetes-related complications and comorbidities
With the development of new technologies embedded in modern smartphones ie depth sensors image-based methods to support food assessment have become widely available Of particular use is the employment of well-established computer vision methodologies to estimate the quantity of food When combined with food-recognition technologies and information from nutritional databases a proposition of the nutritional content eg carbohydrates fat proteins fibres can be made to the user on the basis of captured images and obviates the need for error prone visual estimations and mental calculations Several such applications have become available and can support monitoring the diet as part of lifestyle management
Insights from a recent online survey suggest that a high proportion of people with type 1 diabetes believe that such new technologies for meal management could facilitate their daily self-management and would be interested in using such technology Moreover according to a recent study such digital tools may promote diabetes education and food literacy which may particularly benefit those with a lower education level and with a history of depression
Amongst several options eg Foodvisor Calorie-Mamma Lifesum for image-based food tracking and analysis SNAQ is one of the most commonly used app in people with type 1 diabetes Up to date more than 40000 users have downloaded the SNAQ app in their phones of which 2500 are living in Switzerland
The investigators have previously demonstrated that the system estimates the macronutrient content of real meals with satisfying accuracy
However evidence with regards to the effect of the food analysis on daily self-management of people with type 1 diabetes eg glucose control meal patterns perceived benefits is currently lacking The investigators therefore aim to address these aspects in a randomized-controlled study contrasting the use of the SNAQ app with peoples traditional meal management techniques
Of note more than 60 of individuals with diabetes report having trouble with carbohydrate counting despite their awareness on its importance Even in patients who are confident in applying carbohydrate counting the daily task is perceived as major burden of diabetes self-management
Since carbohydrate counting is particularly demanding when eating fresh non-packaged foods a concerning trend towards unhealthy dietary choices with preference of prepackaged foods with accessible nutrition facts over whole foods is increasingly observed in people with type 1 diabetes This is paralleled by an increasing prevalence of overweight and obesity in the type 1 diabetes population
Thus even with the latest hybrid closed-loop insulin delivery technologies adequate nutrition knowledge remains a cornerstone for satisfactory glucose control metabolic health and prevention of diabetes-related complications and comorbidities
With the development of new technologies embedded in modern smartphones ie depth sensors image-based methods to support food assessment have become widely available Of particular use is the employment of well-established computer vision methodologies to estimate the quantity of food When combined with food-recognition technologies and information from nutritional databases a proposition of the nutritional content eg carbohydrates fat proteins fibres can be made to the user on the basis of captured images and obviates the need for error prone visual estimations and mental calculations Several such applications have become available and can support monitoring the diet as part of lifestyle management
Insights from a recent online survey suggest that a high proportion of people with type 1 diabetes believe that such new technologies for meal management could facilitate their daily self-management and would be interested in using such technology Moreover according to a recent study such digital tools may promote diabetes education and food literacy which may particularly benefit those with a lower education level and with a history of depression
Amongst several options eg Foodvisor Calorie-Mamma Lifesum for image-based food tracking and analysis SNAQ is one of the most commonly used app in people with type 1 diabetes Up to date more than 40000 users have downloaded the SNAQ app in their phones of which 2500 are living in Switzerland
The investigators have previously demonstrated that the system estimates the macronutrient content of real meals with satisfying accuracy
However evidence with regards to the effect of the food analysis on daily self-management of people with type 1 diabetes eg glucose control meal patterns perceived benefits is currently lacking The investigators therefore aim to address these aspects in a randomized-controlled study contrasting the use of the SNAQ app with peoples traditional meal management techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None