NCT06917274

Brief Summary

Former and current KADET athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. Tandem Data recorded includes sensor glucose, training details, insulin dosing, and meal intake. Continuous glucose monitoring (CGM) data is assessed. Endpoints include differences in glucose levels, hypoglycemia events (SG \<3.9 mmol/L), and Time in Range during training

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

March 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 20, 2025

Last Update Submit

March 31, 2025

Conditions

Type 1 Diabetes

Keywords

nutritionCGMblood glucoseexercise

Outcome Measures

Primary Outcomes (1)

  • CGM glucose

    CGM glucose Time in Range between 3.9 and 10 mmol/l

    approximately 60 minute monitoring period during exercise

Secondary Outcomes (2)

  • Time to hypoglycemia

    approximately 30 to 30 minutes

  • Borg scale

    Borg scale is assessed approximately 15 minutes after exercise

Study Arms (2)

No banana

ACTIVE COMPARATOR

No banana consumed prior exercise

Other: No banana

banana

ACTIVE COMPARATOR

Banana consumed 20 minutes prior exercise

Dietary Supplement: Banana

Interventions

BananaDIETARY_SUPPLEMENT

A banana is consumed pre-exercise in order to prevent hypoglycemia

banana
No bananaOTHER

No banana is consumed pre-exercise

No banana

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • type 1 diabetes

You may not qualify if:

  • cardiovascular comorbidity
  • neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rakel Johansen, MD

CONTACT

+45 40530612rfjohansen@clin.au.dk

Esben Vestergaard, MD

CONTACT

21932828esbevest@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2025

First Posted

April 8, 2025

Study Start

April 1, 2025

Primary Completion

November 1, 2025

Study Completion

February 1, 2026

Last Updated

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share