Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes (VARIAFIT)

The primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.

So, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes.

This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: functional insulinotherapy class

Detailed Description

This is a prospective, open, non-controlled study with an individual benefit for the participant. This study is designed to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.

All 30 patients with type 1 diabetes attended a 4-day functional insulinotherapy class, taught by 2 nurses, 2 dieticians and 2 physicians. The participants were recruited among metabolically stable patients who had already been prescribed functional insulinotherapy.

To assess the impact of functional insulinotherapy on blood glucose variability, HbA1c will be measured at 0, 3 months and 6 months along with 4 blood glucose variability indicators: MAGE, ADRR, LI and LBGI.

This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress. Therefore, a measure of insulin antibodies by ELISA at baseline. At baseline and 6 months, LTE4, TXB2, 8-iso-PGF2alpha, anti-transglutaminase and anti-endomysium antibodies will also be assessed.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • Service de Diabétologie du Pr Halimi, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that have been prescribed functional insulinotherapy at University Hospital Grenoble

Description

Inclusion Criteria:

• Patients with type 1 diabetes with pump or multi-injection treatment and attending a functional insulinotherapy class
• Social Security membership or benefit from Social Security
• Informed consent, with a signed and approved form

Exclusion Criteria:

• Underage patient, major patient under guardianship or protected by the Law
• Pregnant, parturient or breastfeeding woman
• Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
• Antecedents of pathologies causing diabetes instability (coeliac disease, gastroparesis, non-balanced psychiatric pathology) and not optimally treated, acute pathology less than 3 months ago (infectious, cardio-vascular, metabolic), pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients with functional insulinotherapy; There is only one group in this study. The participants will attend a functional insulinotherapy class.

Other: functional insulinotherapy class; The functional insulinotherapy class lasts for 4 days. It is taught by 2 nurses, 2 dieticians and 2 physicians to 6 to 10 patients. On day 1, patients describe their difficulties with diabetes. Fast-acting insulin scales are elaborated from preprandial and postprandial blood glucose levels. At dinner, patients start a 24-hour glucose-fasting period to evaluate their need for basal insulin. Meals contain virtually no carbohydrates. Correcting doses of insulin are administered if preprandial glycemia is over 1.50 g/l or postprandial glycemia is over 2 g/l. Blood glucose levels must stay within normal values during the whole 24-hour period. Carbohydrate management is taught during meals and every afternoon through workshops about dietetics. Patients also learn how to deal with hypoglycaemia, hyperglycaemia and physical activity. A one-day follow-up takes place 3 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS	0, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
anti-transglutaminase and anti-endomysium antibodies	0 months, 6 months
dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha	0 months, 6 months
anti-insulin antibodies by ELISA	0 months

Collaborators and Investigators

• Sponsor: Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition
• Investigators: Principal Investigator: Pierre-Yves Benhamou, PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Benhamou PY, Somers F, Lablanche S, Debaty I, Borel AL, Nasse L, Stanke-Labesque F, Faure P, Boizel R, Halimi S. Impact of flexible insulin therapy on blood glucose variability, oxidative stress and inflammation in type 1 diabetic patients: the VARIAFIT study. Diabetes Metab. 2014 Sep;40(4):278-83. doi: 10.1016/j.diabet.2014.01.004. Epub 2014 Feb 24.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: September 7, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 9, 2009
• Last Update Submitted That Met QC Criteria: September 8, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: type 1 diabetes; functional insulinotherapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2007-A00903-50