NCT03554590

DM1, Effects of Carbo-Counting on Glycemic Control

Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	carbohydrate counting	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
BEHAVIORAL	insulin therapy according to standard care	patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2020-01-01
• First posted: 2018-06-13
• Last updated: 2018-06-13

Locations

1 site across 1 country: Italy