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

NCT ID: NCT01173991

Last Updated: 2010-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Insulin Pump, Programmable

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Carbohydrate counting

This group received carbohydrate counting training

Group Type EXPERIMENTAL

Carbohydrate counting training

Intervention Type BEHAVIORAL

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

Controls

This group received standard education

Group Type NO_INTERVENTION

Carbohydrate counting training

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carbohydrate counting training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

IRCCS San Raffaele

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emanuele Bosi, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute, Milano Italy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Raffaele Scientific Institute

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIOCAR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.