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Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes

NCT05481034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-10-18

No results posted yet for this study

Summary

The purpose of the study is to examine whether a simplified meal approach (as compared to exact carbohydrate counting) can alleviate the need of carbohydrate counting without worsening postprandial control in youth and young adults with type 1 diabetes using hybrid closed-loop insulin delivery with the Cambridge Artificial Pancreas FX System (CamAPS FX system).

Conditions

Interventions

DEVICE

SMA bolus option

SMA comprises the selection of predefined carbohydrate quantities for meal insulin dosing. Meal carbohydrate contents will be set on an individual basis at the baseline visit.

DEVICE

Exactly estimated carbohydrate content bolus option

The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Lia Bally

    lead OTHER

Principal Investigators

  • Lia Bally, MD PhD · University hospital of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2023-09-29
Completion
2023-09-29

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481034 on ClinicalTrials.gov