DM1, Effects of Carbo-Counting on Glycemic Control

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: insulin therapy according to standard care; Behavioral: carbohydrate counting

Study type: Interventional

Funder types: Other

Identifiers

NCT03554590

DM1cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 1 diabetes mellitus
• insulin therapy
• HbA1c from 5.5 to 10%

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

carbo-counters

Experimental group

Description:

carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy

Treatment:

Behavioral: carbohydrate counting

control group

Active Comparator group

Description:

insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy

Treatment:

Behavioral: insulin therapy according to standard care