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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1; Insulin Pump, Programmable
• Interventions: Behavioral: Carbohydrate counting training

• Registration Number: NCT01173991
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Status Verified: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-08-02
• Last Update Submitted: 2010-08-02
• Study First Posted: 2010-08-03
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate counting	Carbohydrate counting training	This group received carbohydrate counting training
Controls	Carbohydrate counting training	This group received standard education

Primary Outcome Measures

Name	Time	Method
Glycated haemoglobin (HbA1c)	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milano, Italy