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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Automated carbohydrate and meal insulin dose computing

• Registration Number: NCT02676609
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Use of smart phone application (device glucal)	Automated carbohydrate and meal insulin dose computing	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
Use of smart phone application (second month)	Automated carbohydrate and meal insulin dose computing	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean 2-hour postmeal blood glucose level	4 weeeks	Average 2-hour postmeal blood glucose level during 4 weeks

Trial Locations

Locations (1)

Hôpital Lapeyronie; 🇫🇷 Montpellier, Hérault, France