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

Type 1 Diabetes Clinical Trial

— GLUCAL  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676609
• Other study ID #: UF 9665
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: November 28, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Automated carbohydrate and meal insulin dose computing
Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.

Locations

Country	Name	City	State
France	Hôpital Lapeyronie	Montpellier	Hérault

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-hour postmeal blood glucose values between 80 and 180 mg/dl	Percent 2-hour postmeal blood glucose values between 80 and 180 mg/dl during 4 weeks	4 weeks	No
Secondary	Mean 2-hour postmeal blood glucose level	Average 2-hour postmeal blood glucose level during 4 weeks	4 weeeks	No