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Completed

NCT Number: NCT01512680

Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montpellier University Hospital

Montpellier, 34000, France

About this study

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. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Education to Functional Insulin Therapy

Behavioral
  • 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

Primary outcomes

  1. Difference between HbA1c at Month 12 and Month 0 > 0.5%

    Time frame: at baseline et at Month 12

Secondary outcomes

  1. Difference between HbA1c at Month 3 and Month 0 > 0.3%

    Time frame: at baseline et at Month 3

  2. Difference between HbA1c at Month 6 and Month 0 > 0.5%

    Time frame: at baseline and at Month 6

  3. Difference between HbA1c at Month 9 and Month 0 > 0.5%

    Time frame: at baseline and at Month 9

  4. Reduction of 50% of hypoglycemia < 60mg/dl

    Time frame: at Month 12

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

    Time frame: at Month 12

  6. Reduction of number of patients who have severe hypoglycemia

    Time frame: at MONTH 12

  7. Better score at surveys of quality of life (SF-6D, DQOL) and auto-management

    Time frame: at baseline, at Month 6 and at Month 12

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps

Acronym: IFOPI

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jan 19, 2012
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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