Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes (VARIAFIT)
Recruitment status was Active, not recruiting
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes|
- MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS [ Time Frame: 0, 3 months, 6 months ] [ Designated as safety issue: No ]
- anti-transglutaminase and anti-endomysium antibodies [ Time Frame: 0 months, 6 months ] [ Designated as safety issue: No ]
- dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha [ Time Frame: 0 months, 6 months ] [ Designated as safety issue: No ]
- anti-insulin antibodies by ELISA [ Time Frame: 0 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973492
|Service de Diabétologie du Pr Halimi, CHU|
|Grenoble Cedex 9, France, 38043|
|Principal Investigator:||Pierre-Yves Benhamou, PhD||University Hospital, Grenoble|