NCT00973492

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

September 7, 2009

Last Update Submit

September 8, 2009

Conditions

Type 1 Diabetes

Keywords

type 1 diabetesfunctional insulinotherapy

Outcome Measures

Primary Outcomes (1)

  • MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS

    0, 3 months, 6 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

patients with functional insulinotherapy

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

Other: functional insulinotherapy class

Interventions

functional insulinotherapy classOTHER

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.

patients with functional insulinotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that have been prescribed functional insulinotherapy at University Hospital Grenoble

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Diabétologie du Pr Halimi, CHU

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 24581956DERIVED

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

  • Pierre-Yves Benhamou, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2009

First Posted

September 9, 2009

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations

FR(1)