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Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion (GIOCAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173991
First Posted: August 3, 2010
Last Update Posted: August 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
IRCCS San Raffaele
July 26, 2010
August 3, 2010
August 3, 2010
October 2008
September 2009   (Final data collection date for primary outcome measure)
Glycated haemoglobin (HbA1c) [ Time Frame: 6 months ]
Same as current
No Changes Posted
  • Fasting glucose [ Time Frame: 6 months ]
  • Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data [ Time Frame: 6 months ]
  • Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement) [ Time Frame: 6 months ]
  • Body Mass Index (BMI) [ Time Frame: 6 months ]
  • Waist circumference [ Time Frame: 6 months ]
  • Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire [ Time Frame: 6 months ]
  • Hypoglycemia (capillary glucose<50 mg/dl) [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)
The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic control, glycemic variability and quality of life.
This study was designed as a randomized, controlled (versus standard education), open, one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, while the patients in group 2 followed standard education. Primary outcome (glycosylated hemoglobin, HbA1c) and secondary outcomes (fasting glucose, glycemic variability, insulin requirement, body mass index (BMI), waist circumference, quality of life) were measured at baseline, 3, and 6 months.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Insulin Pump, Programmable
Behavioral: Carbohydrate counting training
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
  • Experimental: Carbohydrate counting
    This group received carbohydrate counting training
    Intervention: Behavioral: Carbohydrate counting training
  • No Intervention: Controls
    This group received standard education
    Intervention: Behavioral: Carbohydrate counting training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
January 2010
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 1 diabetes mellitus
  • age 18-65
  • continuous subcutaneous insulin infusion for at least 3 months

Exclusion Criteria:

  • patients who have already been trained in carbohydrate counting
  • known hypothyroidism not on replacement therapy
  • renal disease (serum creatinine >1.4 mg/dl in females and >1.7 mg/dl in males)
  • patients with celiac disease
  • pregnancy
  • serious diseases or disabilities which may interfere with study assessments
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01173991
GIOCAR
No
Not Provided
Not Provided
Emanuele Bosi, IRCCS San Raffaele
IRCCS San Raffaele
Not Provided
Principal Investigator: Emanuele Bosi, MD San Raffaele Scientific Institute, Milano Italy
IRCCS San Raffaele
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP