NCT02546063

Brief Summary

The standard method for determining the carbohydrate content of a meal in patients with diabetes mellitus is the weighing of individual foods. However, in daily life, the weighing is not practical at all times. Inaccurate estimation of meal's CHO content, leads to wrong insulin doses and consequently to poor postprandial glucose control. Fact is that even well trained diabetic individuals find it difficult to estimate CHO precisely and that especially meals served on a plate are prone to false estimations underlining an emergent need for novel approaches to CHO estimation. GoCarb is a computer vision-based system for calculating the carbohydrate content of meals. In a typical scenario, the user places a credit card-sized reference object next to the meal and acquires two images using his/her smartphone. A series of computer vision modules follows: the plate is detected and the different food items on the plate are automatically segmented and recognized, while their 3D shape is reconstructed. On the basis of the shape, the segmentation results and the reference card, the volume of each item is then estimated. The CHO content is calculated by combining the food types with its volumes, and by using the USDA nutritional database. Finally, the results are displayed to the user. A preclinical study using the GoCarb system indicates that the system is able to estimate the meal's CHO content with higher accuracy than individuals with T1D. Furthermore, the feedback gathered by the participants showed that the system is easy to use even for non-smartphone users. The aim of this randomized, cross-over pilot study is to investigate the benefits of an automated determination of the carbohydrate content of meals on glycemic control in subjects with type 1 diabetes mellitus with sensor-augmented insulin pump therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

September 4, 2015

Last Update Submit

August 9, 2016

Conditions

Diabetes Mellitus, Type 1Carbohydrates

Outcome Measures

Primary Outcomes (1)

  • Average of the postprandial area under the glucose curve (AUC) measured over three hours after each meal's start using Continuous Glucose Monitoring

    14 days

Secondary Outcomes (4)

  • Composite of insulin-related parameters

    14 days

  • Glucose-related parameters

    14 days

  • Daily nutritional behavior in individuals with T1D

    14 days

  • User satisfaction

    14 days

Study Arms (2)

GoCARB app

OTHER

Smartphone app

Other: Smartphone App

Conventional carbohydrate estimating methods

NO INTERVENTION

Individual usual carbohydrate estimation methods (weighing, experience, carbohydrate exchange tables etc.).

Interventions

Smartphone AppOTHER

The GoCARB system is a smartphone application designed to support type 1 diabetic patients with carbohydrate counting by providing automatic, accurate and near real-time CHO estimation for non-packed foods.

GoCARB app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Minimum age of 18 years old
  • Sensor-augmented pump therapy for at least six months
  • HbA1c levels within the last 4 months ≤ 8.5%
  • Familiar with carbohydrate (CHO) counting (e.g. CHO counting training in the past)
  • Normal insulin sensitivity (reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight)
  • Able to comprehend German or English
  • Written informed consent

You may not qualify if:

  • Relevant diabetic complications
  • Hypoglycemia unawareness
  • More than one episode of severe hypoglycemia as defined by American Diabetes Association in preceding 12 months
  • Pregnancy
  • Relevant psychiatric disorder
  • Active neoplasia
  • Participation in another study
  • Other individuals especially in need of protection (according to the guidelines of the Swiss Academy of Medical Sciences)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (4)

  • Anthimopoulos MM, Gianola L, Scarnato L, Diem P, Mougiakakou SG. A food recognition system for diabetic patients based on an optimized bag-of-features model. IEEE J Biomed Health Inform. 2014 Jul;18(4):1261-71. doi: 10.1109/JBHI.2014.2308928.

    PMID: 25014934BACKGROUND

  • Agianniotis A, Anthimopoulos M, Daskalaki E, Drapela A, Stettler C, Diem P, Mougiakakou S. GoCARB in the Context of an Artificial Pancreas. J Diabetes Sci Technol. 2015 May;9(3):549-55. doi: 10.1177/1932296815583333. Epub 2015 Apr 21.

    PMID: 25904142RESULT

  • Anthimopoulos M, Dehais J, Shevchik S, Ransford BH, Duke D, Diem P, Mougiakakou S. Computer vision-based carbohydrate estimation for type 1 patients with diabetes using smartphones. J Diabetes Sci Technol. 2015 May;9(3):507-15. doi: 10.1177/1932296815580159. Epub 2015 Apr 16.

    PMID: 25883163RESULT

  • Bally L, Dehais J, Nakas CT, Anthimopoulos M, Laimer M, Rhyner D, Rosenberg G, Zueger T, Diem P, Mougiakakou S, Stettler C. Carbohydrate Estimation Supported by the GoCARB System in Individuals With Type 1 Diabetes: A Randomized Prospective Pilot Study. Diabetes Care. 2017 Feb;40(2):e6-e7. doi: 10.2337/dc16-2173. Epub 2016 Nov 29. No abstract available.

    PMID: 27899490DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christoph Stettler

    Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

    PRINCIPAL INVESTIGATOR

  • Stavroula Mougiakakou

    Diabetes Technology Research Group, ARTORG Center for Biomedical Engineering Research, University of Bern

    PRINCIPAL INVESTIGATOR

  • Markus Laimer

    Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 10, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)