Effect of Splitting Mealtime Insulin Doses After Mixed Meals High in Fat and Protein

NCT04783376 | Completed Phase 4

• 1 other identifier: Soh-Med-21-01-02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The current management of type 1 diabetes mellitus (T1DM) depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection (MDI) therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or snack. However, several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals. There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen. This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals. The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

• Capillary blood glucose levels before the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter before the test meals

  before the test meals.

• Capillary blood glucose levels one hour after the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter one hour after the test meals

  one hour after the test meal

• Capillary blood glucose levels two hours after the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter two hours after the test meals

  two hours after the test meal

• Capillary blood glucose levels three hours after the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter three hours after the test meals

  three hours after the test meal

• Capillary blood glucose levels four hours after the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter four hours after the test meals

  four hours after the test meal

• Capillary blood glucose levels five hours after the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter five hours after the test meals

  five hours after the test meal

• Capillary blood glucose levels six hours after the test meals.

  Capillary blood glucose levels measured by a calibrated finger-prick blood glucose meter six hours after the test meals

  six hours after the test meal

Secondary Outcomes (2)

• assessment of serum cholesterol level three hours after the test meal following each intervention

  3 hours after test meal

• assessment of serum triglyceride level three hours after the test meal following each intervention

  3 hours after test meal

Study Arms (3)

Arm 1 (usual treatment)

ACTIVE COMPARATOR

intervention A

Drug: : Insulin, lispro and regular insulin

Arm 2(splitted bolus dose, fast-acting insulin only)

ACTIVE COMPARATOR

intervention B

Drug: : Insulin, lispro and regular insulin

Arm 3 (splitted bolus dose, fast acting insulin before the meal and regular insulin after the meal)

ACTIVE COMPARATOR

intervention C

Drug: : Insulin, lispro and regular insulin

Interventions

: Insulin, lispro and regular insulin DRUG

* A: the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100% of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio * B: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60%) will be given 10 minutes before the meal and (40%) will be given 30 minutes after the premeal dose. Both doses will be given as fast-acting insulin. * C: the same as intervention B but the 40% of the total dose will be given as regular insulin.

Arm 1 (usual treatment); Arm 2(splitted bolus dose, fast-acting insulin only); Arm 3 (splitted bolus dose, fast acting insulin before the meal and regular insulin after the meal)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents aged 6 - 18 years
• diagnosed with T1DM for at least 1 year
• using MDI regimen with advanced carbohydrate counting for at least 6 months

You may not qualify if:

• Subjects with associated
• diabetic autonomic neuropathy
• hypothyroidism
• celiac disease.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sawsana Ewieda

Sohag, Egypt

Location

Related Publications (1)

• Hegab AM, Hasaballah SE, Mohamed MM. Splitting Mealtime Insulin Doses for Mixed Fat and Protein Meals in Children and Adolescents with Type 1 Diabetes Using Multiple Daily Injection Regimen: A Randomized Cross-Over Trial. Pediatr Diabetes. 2023 Oct 27;2023:7467652. doi: 10.1155/2023/7467652. eCollection 2023.

  PMID: 40303273 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist registrar at Pediatrics Department, Sohag University Hospital

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 5, 2021
• Study Start: April 12, 2021
• Primary Completion: November 25, 2021
• Study Completion: March 3, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

EG (1)