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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Automated carbohydrate and meal insulin dose computing
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Smart phone application, carbohydrate counting, meal insulin dose

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Lapeyronie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Use of smart phone application (device glucal)

Use of smart phone application (second month)

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean 2-hour postmeal blood glucose level
Average 2-hour postmeal blood glucose level during 4 weeks

Full Information

First Posted
February 3, 2016
Last Updated
November 28, 2016
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02676609
Brief Title
Impact of Food Carbohydrate and Insulin Dose Computing by on Smart Phone on Glucose Control in Patients With Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Smart phone application, carbohydrate counting, meal insulin dose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of smart phone application (device glucal)
Arm Type
Active Comparator
Arm 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
Arm Title
Use of smart phone application (second month)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Automated carbohydrate and meal insulin dose computing
Intervention Description
Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.
Primary Outcome Measure Information:
Title
2-hour postmeal blood glucose values between 80 and 180 mg/dl
Description
Percent 2-hour postmeal blood glucose values between 80 and 180 mg/dl during 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean 2-hour postmeal blood glucose level
Description
Average 2-hour postmeal blood glucose level during 4 weeks
Time Frame
4 weeeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Renard, MD, PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Lapeyronie
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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