Diabetes Mellitus, Type 1Phase 3GIOCARNCT01173991
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
A Phase 3 study testing Carbohydrate counting training in people with Diabetes Mellitus, Type 1 and Insulin Pump, Programmable, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Insulin Pump, Programmable
- What is being tested?
- Carbohydrate counting training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 diabetes mellitus
- age 18-65
- continuous subcutaneous insulin infusion for at least 3 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)
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.
Read the 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.
- Being tested
- Carbohydrate counting training
- Keywords
- carbohydrate counting, continuous subcutaneous insulin infusion, type 1 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate counting trainingBehavioural
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate counting | Experimental | This group received carbohydrate counting training Receives: Behavioral: Carbohydrate counting training |
| Controls | No intervention | This group received standard education Receives: Behavioral: Carbohydrate counting training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin (HbA1c)
Measured: 6 months
Secondary outcomes (7)
Fasting glucose
Measured: 6 months
Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data
Measured: 6 months
Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
Measured: 6 months
Body Mass Index (BMI)
Measured: 6 months
Waist circumference
Measured: 6 months
Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
Measured: 6 months
Hypoglycemia (capillary glucose<50 mg/dl)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Emanuele Bosi, MD, Principal investigator, San Raffaele Scientific Institute, Milano Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173991
- Sponsor's protocol ID
- GIOCAR
- Acronym
- GIOCAR
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)
- ClinicalTrials.gov ID
- NCT01173991
- Acronym / sponsor ID
- GIOCAR / GIOCAR
- Keywords
- carbohydrate counting, continuous subcutaneous insulin infusion, type 1 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate counting | Experimental | Behavioral: Carbohydrate counting trainingThis group received carbohydrate counting training |
| Controls | No intervention | Behavioral: Carbohydrate counting trainingThis group received standard education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 1 diabetes mellitus
- age 18-65
- continuous subcutaneous insulin infusion for at least 3 months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate counting trainingCarbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist. | Behavioural | Carbohydrate counting, Controls |
Primary outcome
Glycated haemoglobin (HbA1c)
Time frame: 6 months
7 secondary outcomes
Fasting glucose
Time frame: 6 months
Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data
Time frame: 6 months
Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Waist circumference
Time frame: 6 months
Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
Time frame: 6 months
Hypoglycemia (capillary glucose<50 mg/dl)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Bosi, MD principal investigator
San Raffaele Scientific Institute, Milano Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carbohydrate counting training in people with Diabetes Mellitus, Type 1 and Insulin Pump, Programmable, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated haemoglobin (HbA1c) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2010.