Back to resultsCarbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion (GIOCAR)
Primary Purpose
Diabetes Mellitus, Type 1, Insulin Pump, Programmable
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Carbohydrate counting training
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring carbohydrate counting, continuous subcutaneous insulin infusion, type 1 diabetes mellitus
Eligibility 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
Sites / Locations
- San Raffaele Scientific Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Carbohydrate counting
Controls
Arm Description
This group received carbohydrate counting training
This group received standard education
Outcomes
Primary Outcome Measures
Glycated haemoglobin (HbA1c)
Secondary Outcome Measures
Fasting glucose
Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data
Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
Body Mass Index (BMI)
Waist circumference
Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
Hypoglycemia (capillary glucose<50 mg/dl)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01173991
Brief Title
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
Acronym
GIOCAR
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Insulin Pump, Programmable
Keywords
carbohydrate counting, continuous subcutaneous insulin infusion, type 1 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate counting
Arm Type
Experimental
Arm Description
This group received carbohydrate counting training
Arm Title
Controls
Arm Type
No Intervention
Arm Description
This group received standard education
Intervention Type
Behavioral
Intervention Name(s)
Carbohydrate counting training
Intervention Description
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
Primary Outcome Measure Information:
Title
Glycated haemoglobin (HbA1c)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fasting glucose
Time Frame
6 months
Title
Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data
Time Frame
6 months
Title
Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
Time Frame
6 months
Title
Body Mass Index (BMI)
Time Frame
6 months
Title
Waist circumference
Time Frame
6 months
Title
Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
Time Frame
6 months
Title
Hypoglycemia (capillary glucose<50 mg/dl)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuele Bosi, MD
Organizational Affiliation
San Raffaele Scientific Institute, Milano Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Scientific Institute
City
Milano
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
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