SUCCEED - Soroka Utility for Counting Carbs Easily and Effectively for Diabetes

NCT04132128 | Completed

• 1 other identifier: SOR- 0320-15 CTIL
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

Counting Carbohydrates (CC) is the preferable method used to calculate the amount of insulin needed for a meal. This method is employed by patients with type 1 diabetes melitus (T1DM). the patients receive the general arithmetic calculation of how much insulin to inject for 15 grams/1 portion of carbohydrate (carb to insulin ratio (C:I) and insulin sensitivity (IS). However, Diabetes Educators are often confronted with difficulties guiding their T1DM patient when using this method and find patients get confused calculating the amount of carbs needed. The investigators sought to create a simple tool that would help our patients implement the CC method easily and properly.

Conditions

Diabetes Mellitus; Carbohydrates; Insulin Sensitivity; HbA1C

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1C for measuring glucose control

  6 months after intervention

Secondary Outcomes (2)

• patients satisfaction

  6 months after intervention

• HbA1C for measuring glucose control

  3 months after intervention

Study Arms (2)

study

EXPERIMENTAL

6 meetings with a dietician diabetes educator assimilating simple CC tool

Other: carbohydrate counting

control

OTHER

meeting with dietician as needed with regular education of CC

Other: carbohydrate counting

Interventions

carbohydrate counting OTHER

taught how to count carbohydrates in their diet with their personal tool

control; study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or woman with a clinical diagnosis of DM TYPE 1
• Age- \>18
• Insulin treatment: pump or injection in basal- bolus system

You may not qualify if:

• No insulin treatment
• %\> HbA1C.
• Pregnancy or Breastfeeding.
• Critical illness such as ens stage cancer or CHF
• Recurrent hospitalizations.

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Shula Witko

  Diabetes Clinic Dietitian, Soroka University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking - open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Diabetes Clinic

Model Details: described in above section

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: October 18, 2019
• Study Start: November 25, 2015
• Primary Completion: February 28, 2018
• Study Completion: August 5, 2019
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL