Additional Insulin for High Fat/Protein in Type 1 Diabetes

Summary

Aim: Dietary carbohydrate is the predominant macronutrient affecting postprandial blood glucose excursions, dietary fat and protein can also significantly impact the postprandial glycemic profile. The aim of this study is to compare the impact of additional dose of extended insulin bolus; using Pankowsko algorithm (PA) to usual standard carbohydrate counting (CC) on postprandial glucose excursions for high fat /high energy density mixed meal for 12 hours.

Methods: In this single-center, non-blinded, randomized, crossover study a high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%) was given using standard carbohydrate counting (CC) on the first test day and PA was used for the second test day for the same meal. Two methods were compared on postprandial early (0-120 min), late (120-720 min) and total (0-720 min) glucose response in 20 patients with type 1 diabetes mellitus (T1DM), aged 9-18 years on continuous subcutan insulin infusion (CSII) therapy using continuous glucose monitoring system (CGMS).

Conditions

• Type 1 Diabetes
• Adolescent

Interventions

OTHER

Carb and fat counting

In the 7 days leading up to the study, participants were contacted to review blood glucose levels with CGMS, food and activity diary. basal rates and insulin carbohydrate ratio and sensitivity factor were changed according to the CGMS values and normoglycemia was achieved.In the study day same meals were served which included high fat, high energy density test meal containing 80 gram carbohydrate (34%), 70 gram fat (66%) and 35 g protein (14%).The participants had to have no glucose fluctuations 2 hours before study entry based on CGMS, no correction boluses for at least 4 hours before the test meal consumption and fasting glycemia in the range of 70-180 mg/dL on both study days.The participants received the test meal calculating insulin dose by CC on the first study day and calculating insulin dose by and fat/protein counting in the second study day. The test meal consumption was completed in 20 minutes under supervision by a caregiver and a dietician of the research team

Sponsors & Collaborators

• Ege University

  lead OTHER

Principal Investigators

• Sukran Darcan, MD Prof · Ege University

• Yasemin Atik Altınok, pHD · Ege University Fac Of Medicine Department of Pediatrics

• Hafize Cetin Işıklar, Nurse · Ege University Fac Of Medicine Department of Pediatrics

• Gunay Demir, MSci Nurse · Ege University Fac Of Medicine Department of Pediatrics

• Samim Ozen, MD,PhD · Ege University Fac Of Medicine Department of Pediatrics

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

9 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2018-04-30

Completion

2019-12-31

Countries

• Turkey (Türkiye)

Study Locations