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Teens with type 1 diabetes: counting protein and fat may improve blood sugar control

NCT ID NCT07158385

Knowledge-focused Sponsor: Cumhuriyet University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether counting protein and fat, in addition to carbohydrates, helps control blood sugar after meals in adolescents with type 1 diabetes. Eleven teens using insulin pumps ate standard and high-fat-high-protein meals, and their blood sugar, hormones, and fatty acids were tracked for 6 hours. The goal was to see if adjusting insulin for all nutrients improves post-meal glucose levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Standard meal and high-fat-high-protein meals with different insulin dosing strategies
What this could lead to
If successful, this could lead to better insulin dosing guidelines that account for protein and fat, helping teens with type 1 diabetes manage blood sugar after meals.
What could go wrong
This was a small, completed study with only 11 participants, so results may not apply to everyone. It was also a single-center trial, limiting generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

Jan 2019

Finished

Feb 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * No chronic disease other than type 1 diabetes mellitus * Receiving continuous insulin infusion pump therapy Exclusion Criteria: * The individual's insulin requirement is less than 0.5 IU/kg/day * High HbA1c (\>8%) * Presence of complications (Microalbuminuria, etc.) * Presence of a comorbidity (Celiac disease, etc.) * New initiation of CSII treatment (\<6 months) * Living outside Ankara * Parental and individual reluctance * The individual refuses to donate blood during the test meals

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent Type 1 diabetes mellitus

Contacts and locations

Locations

  • Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Nutrition and Dietetics

    Sivas, Turkey (Türkiye)

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