Skip to main content
OpenTrials
Completed

NCT Number: NCT05152121

Additional Insulin for High Fat/Protein in Type 1 Diabetes

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Adolescent Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine Department of Pediatrics

Izmir, 35100, Turkey (Türkiye)

About this study

Children and adolescents with T1DM between the ages of 9-18 and undergoing insulin infusion pump therapy followed in Ege University Pediatric Endocrinology Department will be randomly selected regardless of metabolic control. The selection of the cases will be made from the beginning of the study as the first 30 patients who meet the research participation criteria and agree to participate in the study. Before the research starts, the cases will be told about the application of CGMS, their responsibilities in the research, and an appointment will be given for the insertion of CGMS and this procedure will be applied to all participants. On the day of the appointment, the participant will be put on CGMS, and as long as CGMS is attached, they will be asked to measure capillary blood glucose in their diaries and record them. The subjects will be checked whether they are within the target blood glucose values for 2 days before consuming the test meal and normoglycemia will be provided. On the first day of the study, a test meal with 80 g carbohydrate (29.3%), 70.2 g fat (57.9%), 34.7 g protein (12.7%), will be consumed in the evening meal and carbohydrate counting-normal bolus insulin will be given by administration. On the second day of the study, the additional insulin for fat and protein will be given as a dual wave bolus instead of the normal bolus for the test meal. Then, CGMS will be extracted from the cases, transferred to the computer, and analysis will be made by the researcher, taking into account the capillary blood glucose measurements in the diary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children-adolescents with Type 1 DM between the ages of 9-18 and undergoing insulin infusion pump therapy followed by Ege University Faculty of Medicine, Department of Pediatric Endocrine.
  • Those with a body mass index between -2- + 2 SD

Exclusion criteria

  • Cases that do not accept to fill in the 'Informed Consent Form'
  • Cases with diseases accompanying T1DM (autoimmune diseases such as celiac, cystic fibrosis, etc.)
  • Body mass index <-2 SD and> +2 SD

Treatment and study plan

Carb and fat counting

Other

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

Primary outcomes

  1. AUC

    Time frame: AUC was evaluated the day where only carbs were counted and the day were fat and proteins were counted

    The primary outcomes were glucose area under the curve (AUC) and % of time spent in normoglycemia according to CC; PA and modified PA algorithms.

Secondary outcomes

  1. hypoglycemia epizode

    Time frame: Hypoglycemia was evaluated the day where only carbs were counted and the day were fat and proteins were counted

    The secondary outcomes were the number of hypoglycemic events over the study period based on capillary blood glucose measurements.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Fat - Protein Counting on Glycemic Variability in Children and Adolescents With Type 1 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 9, 2021
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.