The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy

NCT ID: NCT06567158

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2025-12-31

Brief Summary

In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet

The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period.

Group Type: EXPERIMENTAL

Moderate carbohydrate diet

Intervention Type: OTHER

During the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake.

Traditional diet

Intervention Type: OTHER

During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.

Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet

The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period.

Group Type: EXPERIMENTAL

Moderate carbohydrate diet

Intervention Type: OTHER

During the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake.

Traditional diet

Intervention Type: OTHER

During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.

Interventions

Moderate carbohydrate diet

During the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake.

Intervention Type: OTHER

Traditional diet

During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed informed consent (ICF) (both children/adolescents and parents)
• ≥7 and ≤17 years old at moment of ICF signature
• ≥6 months type 1 diabetes diagnosis at moment of ICF signature
• ≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
• Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature

Exclusion Criteria

• <7 or >17 years old at moment of ICF signature
• <6 months type 1 diabetes diagnosis at moment of ICF signature
• <3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
• Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
• Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina Casteels, Prof

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Kristina Casteels, Prof

Role: CONTACT

kristina.casteels@uzleuven.be

+3216343811

Laura Valgaerts

Role: CONTACT

laura.valgaerts@uzleuven.be

+3216343890

Facility Contacts

Kristina Casteels, Prof

Role: primary

kristina.casteels@uzleuven.be

+3216343811

Laura Valgaerts

Role: backup

laura.valgaerts@uzleuven.be

+3216343890

Other Identifiers

S68499

Identifier Type: -

Identifier Source: org_study_id