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

University Hospital Center (CHU)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Automated carbohydrate and meal insulin dose computing

Study type: Interventional

Funder types: Other

Identifiers

NCT02676609

UF 9665

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Use of smart phone application (device glucal)

Active Comparator group

Description:

Before each meal patient will enter in the application food intakes. Automated carbohydrate and meal insulin dose computing according to individual meal insulin/carbohydrate ratio. During the first month, then during the second month they'll use as usual their traintement and meal without the apllication

Treatment:

Device: Automated carbohydrate and meal insulin dose computing

Use of smart phone application (second month)

Active Comparator group

Description:

During the first month they'll use as usual their traintement and meal without the apllication ,then during the second month they'll use the apllicatioin. Before each meal patient will enter in the application food intakes. Automated carbohydrate and meal insulin dose computing according to individual meal insulin/carbohydrate ratio.

Treatment:

Device: Automated carbohydrate and meal insulin dose computing