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Completed

NCT Number: NCT01173991

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insulin Pump, Programmable Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Raffaele Scientific Institute

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate counting training

Behavioral

Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.

Primary outcomes

  1. Glycated haemoglobin (HbA1c)

    Time frame: 6 months

Secondary outcomes

  1. Fasting glucose

    Time frame: 6 months

  2. Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data

    Time frame: 6 months

  3. Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)

    Time frame: 6 months

  4. Body Mass Index (BMI)

    Time frame: 6 months

  5. Waist circumference

    Time frame: 6 months

  6. Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire

    Time frame: 6 months

  7. Hypoglycemia (capillary glucose<50 mg/dl)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: GIOCAR

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 3, 2010
Registry last updated
Aug 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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