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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)

Conditions
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Diabetes Mellitus, Type 1, Insulin Pump, Programmable

Intervention / Treatment
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* Behavioral: Carbohydrate counting training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrate counting<br>This group received carbohydrate counting training | Behavioral: Carbohydrate counting training<br>* Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.<br>|
| No Intervention: Controls<br>This group received standard education | Behavioral: Carbohydrate counting training<br>* Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose |  | 6 months | 
| Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data |  | 6 months | 
| Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement) |  | 6 months | 
| Body Mass Index (BMI) |  | 6 months | 
| Waist circumference |  | 6 months | 
| Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire |  | 6 months | 
| Hypoglycemia (capillary glucose<50 mg/dl) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrate counting, continuous subcutaneous insulin infusion, type 1 diabetes mellitus