NCT06699485

Brief Summary

The current management of type 1 diabetes mellitus (T1DM) involves the use intensive insulin therapy, frequent blood glucose monitoring and carbohydrate counting. There is a need to strengthen some of the T1DM management aspects as dietary intervention in order to achieve better glycemic and metabolic control. The international society for pediatric and adolescent diabetes (ISPAD) recommend that children and adolescents with T1DM have about 50% of their total daily caloric requirement from carbohydrates. However, an alternative approach is emerging in recent years. The use of low-carbohydrate diet is suggested to reduce postprandial hyperglycemia and glycemic variability and lower the required insulin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

November 16, 2024

Last Update Submit

January 18, 2026

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • The blood glucose level

    The blood glucose levels will be measured for the study participants by finger-stick glucometer

    6 months

Study Arms (1)

Group 1

EXPERIMENTAL

Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year

Dietary Supplement: Low carb diet

Interventions

Low carb dietDIETARY_SUPPLEMENT

Low-carbohydrate diet contains (\<26% carbohydrates) or less than 130 g/d

Group 1

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year attending the Pediatric diabetes clinic at Sohag University Hospital and using the MDI regimen and carbohydrate counting methods are eligible for the study.

You may not qualify if:

  • Children and adolescents with associated diseases such as autoimmune hypothyroidism or celiac disease and those with diabetes-related complications such as diabetic neuropathy, retinopathy or nephropathy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag universty hospital

Sohag, Egypt

Location

Related Publications (4)

  • Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, Bravata DM. Efficacy and safety of low-carbohydrate diets: a systematic review. JAMA. 2003 Apr 9;289(14):1837-50. doi: 10.1001/jama.289.14.1837.

    PMID: 12684364BACKGROUND

  • Mitsui Y, Kuroda A, Ishizu M, Mori H, Kurahashi K, Kondo T, Yoshida S, Akehi Y, Aihara KI, Endo I, Abe M, Matsuhisa M. Basal insulin requirement in patients with type 1 diabetes depends on the age and body mass index. J Diabetes Investig. 2022 Feb;13(2):292-298. doi: 10.1111/jdi.13547. Epub 2021 May 3.

    PMID: 33740836BACKGROUND

  • Kuroda A, Yasuda T, Takahara M, Sakamoto F, Kasami R, Miyashita K, Yoshida S, Kondo E, Aihara K, Endo I, Matsuoka TA, Kaneto H, Matsumoto T, Shimomura I, Matsuhisa M. Carbohydrate-to-insulin ratio is estimated from 300-400 divided by total daily insulin dose in type 1 diabetes patients who use the insulin pump. Diabetes Technol Ther. 2012 Nov;14(11):1077-80. doi: 10.1089/dia.2012.0109.

    PMID: 23101953BACKGROUND

  • Abraham MB, Jones TW, Naranjo D, Karges B, Oduwole A, Tauschmann M, Maahs DM. ISPAD Clinical Practice Consensus Guidelines 2018: Assessment and management of hypoglycemia in children and adolescents with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27:178-192. doi: 10.1111/pedi.12698. No abstract available.

    PMID: 29869358BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of pediatric department

Study Record Dates

First Submitted

November 16, 2024

First Posted

November 21, 2024

Study Start

January 1, 2025

Primary Completion

October 6, 2025

Study Completion

October 6, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

EG(1)