Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Smart phone application, carbohydrate counting, meal insulin dose
Brief 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.
Detailed 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.
Interventions
DEVICEAutomated 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.
Sponsors
Université Montpellier
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-hour postmeal blood glucose values between 80 and 180 mg/dl | 4 weeks | Percent 2-hour postmeal blood glucose values between 80 and 180 mg/dl during 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean 2-hour postmeal blood glucose level | 4 weeeks | Average 2-hour postmeal blood glucose level during 4 weeks |
Countries
France
Outcome results
None listed