Additional Insulin for High Fat/Protein in Type 1 Diabetes

Not Applicable

Completed

• Conditions: Adolescent; Type 1 Diabetes
• Interventions: Other: Carb and fat counting

• Registration Number: NCT05152121
• Lead Sponsor: Ege University

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-04-30
• Study Completion: 2019-12-31
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Status Verified: 2021-12
• Study First Posted: 2021-12-09
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 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.
2. Those with a body mass index between -2- + 2 SD

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carb counting	Carb and fat counting	Patients using insulin infusion pumps will be placed CGMS for 2 days before starting the study to check whether they are within the target blood glucose levels and normoglycemia will be provided. The content of the first day of the study; The test meal, which is 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 normal bolus insulin will be given according to carbohydrate counting. On the second day of the study, instead of the normal bolus for the test meal, the additional insulin for fat-protein by dual wave bolus that.The data obtained will be analyzed by evaluating the CGMS data of all patients by a pediatric endocrinologist experienced in diabetes, CGMS and insulin infusion pump therapy.

Primary Outcome Measures

Name	Time	Method
AUC	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 Outcome Measures

Name	Time	Method
hypoglycemia epizode	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.

Trial Locations

Locations (1)

Ege University Faculty of Medicine Department of Pediatrics; 🇹🇷 İzmir, Turkey