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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:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01173991
First received: July 26, 2010
Last updated: August 2, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Insulin Pump, Programmable
 Behavioral: Carbohydrate counting training
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Glycated haemoglobin (HbA1c) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hypoglycemia (capillary glucose<50 mg/dl) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbohydrate counting
This group received carbohydrate counting training
 Behavioral: Carbohydrate counting training
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
No Intervention: Controls
This group received standard education
 Behavioral: Carbohydrate counting training
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173991

Locations
Italy
San Raffaele Scientific Institute
Milano, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Emanuele Bosi, MD San Raffaele Scientific Institute, Milano Italy
  More Information

No publications provided

Responsible Party: Emanuele Bosi, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01173991     History of Changes
Other Study ID Numbers: GIOCAR
Study First Received: July 26, 2010
Last Updated: August 2, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
carbohydrate counting
continuous subcutaneous insulin infusion
type 1 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013