NCT01512680

Brief Summary

Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Typical duration for phase_2

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3.1 years

First QC Date

December 16, 2011

Last Update Submit

November 28, 2016

Conditions

Type 1 Diabetes

Keywords

Functional Insulin ThearpyCarbs countingType 1 diabetes mellitusInsulin pumpTreatment by external insulin pump

Outcome Measures

Primary Outcomes (1)

  • Difference between HbA1c at Month 12 and Month 0 > 0.5%

    at baseline et at Month 12

Secondary Outcomes (7)

  • Difference between HbA1c at Month 3 and Month 0 > 0.3%

    at baseline et at Month 3

  • Difference between HbA1c at Month 6 and Month 0 > 0.5%

    at baseline and at Month 6

  • Difference between HbA1c at Month 9 and Month 0 > 0.5%

    at baseline and at Month 9

  • Reduction of 50% of hypoglycemia < 60mg/dl

    at Month 12

  • Reduction of 30% of hypoglycemia between 60 and 80mg/dl

    at Month 12

  • +2 more secondary outcomes

Study Arms (1)

Type 1 diabetes patient

EXPERIMENTAL

Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention)

Behavioral: Education to Functional Insulin Therapy

Interventions

Education to Functional Insulin TherapyBEHAVIORAL

* Intake of Continuous Glucose Monitor for 5 to 7 days * "Functional Insulinotherapy" training during 3 days, blood sampling, autoevaluation and QOL questionnary. * 1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes * 3 months after the training: Blood sampling, vital signs and data on diabetes * 6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days * 9 months after the training: Blood sampling, vital signs and data on diabetes * 1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days * 12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary

Type 1 diabetes patient

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 70
  • Type 1 diabetes for more than 1 year
  • Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
  • HbA1c between 7.5 and 12%
  • Volunteer to be educated to Functional Insulin Therapy
  • Patient must be willing to undergo all study procedures
  • Patient must be affiliated or beneficiary of a social medical insurance
  • Patient has signed informed consent form prior to study entry

You may not qualify if:

  • Type 2 diabetes
  • Difficulties with mathematics calculation (simple algebra)
  • Patient is pregnant, or breast feeding during the period of the study
  • Manifest psychological disorders
  • Patient with eating behaviour desorder
  • Alcohol or drug addiction, as identified by investigator during screening visit
  • Persons deprived of freedom, adults protected by law or vulnerable persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 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 ER RENARD, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 19, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

November 1, 2015

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

FR(1)