Impact of Food Carbohydrate and Insulin Dose Computing by on Smart Phone on Glucose Control in Patients With Diabetes (GLUCAL)
November 28, 2016 updated by: University Hospital, Montpellier
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hérault
-
Montpellier, Hérault, France, 34000
- Hopital Lapeyronie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Use of smart phone application (device glucal)
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 will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.
|
|
Active Comparator: Use of smart phone application (second month)
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. |
Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean 2-hour postmeal blood glucose level
Time Frame: 4 weeeks
|
Average 2-hour postmeal blood glucose level during 4 weeks
|
4 weeeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Eric RENARD, MD, PhD, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
February 3, 2016
First Submitted That Met QC Criteria
February 3, 2016
First Posted (Estimate)
February 8, 2016
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF 9665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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