The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy (COMBINE1)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: Traditional diet; Other: Moderate carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06567158

S68499

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Moderate carbohydrate diet

Other: Traditional diet

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

Experimental group

Description:

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.

Treatment:

Other: Moderate carbohydrate diet

Other: Traditional diet