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Type 1 Diabetes MellitusNCT03554590

DM1, Effects of Carbo-Counting on Glycemic Control

A study testing carbohydrate counting in people with Type 1 Diabetes Mellitus, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
carbohydrate counting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
Dec 2016to Jan 2020
Phase
Interventional
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
  • insulin therapy
  • HbA1c from 5.5 to 10%

Who cannot join

  • pregnancy
  • celiac disease
  • hepatic impairment
  • chronic renal failure

Trial locations and contacts

1 site in 1 country.

Emanuela Orsi, MD contact

0255034590

emanuela_orsi@yahoo.it

valeria grancini, MD contact

0039 3926233299

valeria_grancini@hotmail.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20133

    Valeria Grancini, MD, 00393926233299, valeria_grancini@hotmail.it

    Recruiting

Other trials in Italy

About this study

Official title: Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients

Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits. This study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in T1DM patients who practice CHO-counting, after attending a structured course to learn how to manage this tecnique, vs a control Group, in a follow up period of 2 years.

Read the detailed description

patients with type 1 DM will be enrolled in the study. patients in the intervention group will attend a 5-lessons training to learn how to manage insulin therapy depending on the amount of carbohydrates in their meals, patients in the control group will be follow according to the the standard care. after the follow up period glycometabolic, anthropometric parameters and dietary lifestyle changes will be compared between the two groups.

Being tested
carbohydrate counting, insulin therapy according to standard care
Keywords
carbohydrate counting, insulin therapy
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 countingBehavioural

    patients will attend a 5 meetings-structured training to learn how to manage their insulin therapy depending on the amount of carbohydrates contained in foods

  • insulin therapy according to standard careBehavioural

    patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme

Study groups in NCT03554590
Study groupRoleWhat they receive
carbo-countersExperimentalcarbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
Receives: Behavioral: carbohydrate counting
control groupActive comparatorinsulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy
Receives: Behavioral: insulin therapy according to standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. glycemic control

    HbA1c

    Measured: 2 years

Secondary outcomes (6)

  1. anthropometric parameters: BMI

    variations in body mass index (BMI: units kg/m2), weight and height will be combined to report BMI in kg/m^2

    Measured: 2 years

  2. anthropometric parameters: WAIST AND HIP CIRCUMFERENCE

    variations in waist and hip circumference (units: cm)

    Measured: 2 years

  3. anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS

    fat mass and free fat mass (units: % of total mass)

    Measured: 2 years

  4. dietary lifestyle

    variations in intake of simple sugars, animal protein rich foods, saturated fats and cholesterol, UDM: grams/die. All the informations will be collected using 5days food diaries, completed by the patients.

    Measured: 2 years

  5. glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG)

    mean and standard deviation of self monitoring blood glucose (SMBG), data collected from glucometers, units: mg/dl

    Measured: 2 YEARS

  6. glucose variability: incidence of hypoglycaemia

    incidence of hypoglycaemia (SMBG < 70 mg/dl), units: n° episodes/week

    Measured: 2 YEARS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study startDec 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03554590
Sponsor's protocol ID
DM1cc
Status last verified
May 2018
First submitted
3 Mar 2017
Last updated
13 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing carbohydrate counting in people with Type 1 Diabetes Mellitus, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2018. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emanuela Orsi, MD (0255034590, emanuela_orsi@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

glycemic control (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03554590.

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 13 Jun 2018.

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