DM1, Effects of Carbo-Counting on Glycemic Control
Primary Purpose
Type 1 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
carbohydrate counting
insulin therapy according to standard care
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring carbohydrate counting, insulin therapy
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes mellitus
- insulin therapy
- HbA1c from 5.5 to 10%
Exclusion Criteria:
- pregnancy
- celiac disease
- hepatic impairment
- chronic renal failure
Sites / Locations
- Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
carbo-counters
control group
Arm Description
carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy
Outcomes
Primary Outcome Measures
glycemic control
HbA1c
Secondary Outcome Measures
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
anthropometric parameters: WAIST AND HIP CIRCUMFERENCE
variations in waist and hip circumference (units: cm)
anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
fat mass and free fat mass (units: % of total mass)
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.
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
glucose variability: incidence of hypoglycaemia
incidence of hypoglycaemia (SMBG < 70 mg/dl), units: n° episodes/week
Full Information
NCT ID
NCT03554590
First Posted
March 3, 2017
Last Updated
May 31, 2018
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT03554590
Brief Title
DM1, Effects of Carbo-Counting on Glycemic Control
Official Title
Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
carbohydrate counting, insulin therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
carbo-counters
Arm Type
Experimental
Arm Description
carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy
Intervention Type
Behavioral
Intervention Name(s)
carbohydrate counting
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
insulin therapy according to standard care
Intervention Description
patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme
Primary Outcome Measure Information:
Title
glycemic control
Description
HbA1c
Time Frame
2 years
Secondary Outcome Measure Information:
Title
anthropometric parameters: BMI
Description
variations in body mass index (BMI: units kg/m2), weight and height will be combined to report BMI in kg/m^2
Time Frame
2 years
Title
anthropometric parameters: WAIST AND HIP CIRCUMFERENCE
Description
variations in waist and hip circumference (units: cm)
Time Frame
2 years
Title
anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
Description
fat mass and free fat mass (units: % of total mass)
Time Frame
2 years
Title
dietary lifestyle
Description
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.
Time Frame
2 years
Title
glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG)
Description
mean and standard deviation of self monitoring blood glucose (SMBG), data collected from glucometers, units: mg/dl
Time Frame
2 YEARS
Title
glucose variability: incidence of hypoglycaemia
Description
incidence of hypoglycaemia (SMBG < 70 mg/dl), units: n° episodes/week
Time Frame
2 YEARS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes mellitus
insulin therapy
HbA1c from 5.5 to 10%
Exclusion Criteria:
pregnancy
celiac disease
hepatic impairment
chronic renal failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuela Orsi, MD
Phone
0255034590
Email
emanuela_orsi@yahoo.it
First Name & Middle Initial & Last Name or Official Title & Degree
valeria grancini, MD
Phone
0039 3926233299
Email
valeria_grancini@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuela Orsi
Organizational Affiliation
FOndazione IRCCS Ca' Granda Opedale Maggiore Policlinico Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Grancini, MD
Phone
00393926233299
Email
valeria_grancini@hotmail.it
12. IPD Sharing Statement
Plan to Share IPD
No
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DM1, Effects of Carbo-Counting on Glycemic Control
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