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OpenTrials
Completed

NCT Number: NCT02676609

Impact of Food Carbohydrate and Insulin Dose Computing by on Smart Phone on Glucose Control in Patients With Diabetes

During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months. They will complete two one-month study phases, using the application in one phase and counting carbohydrate and insulin doses without the application in the other phase, with randomized order of each phase. Visits are scheduled at the start and at the end of each phase to collect data on glucose control and insulin doses. Questionnaires assessing health-related quality of life and ability of self-management of diabetes will also be filled by patients before and after each study phase.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lapeyronie

Montpellier, Hérault, 34000, France

About this study

During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes since more than 1 year
  • Basal-bolus insulin regimen since more than 6 months
  • Daily practice of food carbohydrate counting since more than 6 months
  • HbA1c level below 12%

Exclusion criteria

  • Type 2 diabetes
  • No ability to use a smart phone
  • Pregnancy or lactation
  • Severe psychiatric disorders
  • Eating disorders
  • Alcohol abuse or recreational drug use

Treatment and study plan

Automated carbohydrate and meal insulin dose computing

Device

Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.

Primary outcomes

  1. 2-hour postmeal blood glucose values between 80 and 180 mg/dl

    Time frame: 4 weeks

    Percent 2-hour postmeal blood glucose values between 80 and 180 mg/dl during 4 weeks

Secondary outcomes

  1. Mean 2-hour postmeal blood glucose level

    Time frame: 4 weeeks

    Average 2-hour postmeal blood glucose level during 4 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Université Montpellier

Registry information

Official study title

Assessment of the Impact of Food Carbohydrate and Insulin Dose Computing by an Application on Smart Phone on Glucose Control in Patients With Type 1 Diabetes

Acronym: GLUCAL

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2016
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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