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

August 2, 2010 updated by: IRCCS San Raffaele

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20132
        • San Raffaele Scientific Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycated haemoglobin (HbA1c)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Waist circumference
Time Frame: 6 months
6 months
Fasting glucose
Time Frame: 6 months
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
6 months
Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
Time Frame: 6 months
6 months
Body Mass Index (BMI)
Time Frame: 6 months
6 months
Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
Time Frame: 6 months
6 months
Hypoglycemia (capillary glucose<50 mg/dl)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Emanuele Bosi, MD, San Raffaele Scientific Institute, Milano Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2010

Last Update Submitted That Met QC Criteria

August 2, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIOCAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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