NCT02676609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

February 3, 2016

Last Update Submit

November 28, 2016

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesSmart phone applicationcarbohydrate countingmeal insulin dose

Outcome Measures

Primary Outcomes (1)

  • 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

    4 weeks

Secondary Outcomes (1)

  • Mean 2-hour postmeal blood glucose level

    4 weeeks

Study Arms (2)

Use of smart phone application (device glucal)

ACTIVE COMPARATOR

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

Device: Automated carbohydrate and meal insulin dose computing

Use of smart phone application (second month)

ACTIVE COMPARATOR

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.

Device: Automated carbohydrate and meal insulin dose computing

Interventions

Automated carbohydrate and meal insulin dose computingDEVICE

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 (device glucal)Use of smart phone application (second month)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Type 2 diabetes
  • No ability to use a smart phone
  • Pregnancy or lactation
  • Severe psychiatric disorders
  • Eating disorders
  • Alcohol abuse or recreational drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lapeyronie

Montpellier, Hérault, 34000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric Renard, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

FR(1)