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

NCT ID: NCT02676609

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Keywords

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Type 1 diabetes Smart phone application carbohydrate counting meal insulin dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Automated carbohydrate and meal insulin dose computing

Intervention Type DEVICE

Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.

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.

Group Type ACTIVE_COMPARATOR

Automated carbohydrate and meal insulin dose computing

Intervention Type DEVICE

Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.

Interventions

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Automated 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Montpellier

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Renard, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Hôpital Lapeyronie

Montpellier, Hérault, France

Site Status

Countries

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France

Other Identifiers

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UF 9665

Identifier Type: -

Identifier Source: org_study_id