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

San Donato Group (GSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Insulin Pump, Programmable

Treatments: Behavioral: Carbohydrate counting training

Study type: Interventional

Funder types: Other

Identifiers

NCT01173991

GIOCAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Carbohydrate counting

Experimental group

Description:

This group received carbohydrate counting training

Treatment:

Behavioral: Carbohydrate counting training

Controls

No Intervention group

Description:

This group received standard education

Treatment:

Behavioral: Carbohydrate counting training