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Hypoglycemia Thresholds in Type 1 Diabetes

14. juli 2026 opdateret af: Marmara University

Impact of Two Different Hypoglycemia Thresholds on Rebound Hyperglycemia in Children With Type 1 Diabetes: A Crossover Clinical Trial

The aim of this study is to compare the impact of hypoglycaemia treatment initiated at a blood glucose threshold of 65 mg/dL versus the internationally recommended threshold of 70 mg/dL on 2-hour post-treatment blood glucose levels and the subsequent development of rebound hyperglycaemia in children with type 1 diabetes. The main questions it aims to answer are:

Is there a statistically significant difference in 2-hour post-treatment blood glucose levels in children with type 1 diabetes when hypoglycaemia intervention is initiated at a threshold of 70 mg/dL compared to 65 mg/dL?"

In children with type 1 diabetes, does the standard hypoglycaemia treatment initiated at the internationally recommended threshold of 70 mg/dL lead to the development of rebound hyperglycaemia (<180 mg/dL) at the 2nd hour post-treatment?

Patients underwent two protocols: intervention at a 65 mg/dl threshold (hospital routine; experimental group) and 70 mg/dl (literature standard; control group). Both protocols utilised 0.3 g/kg of simple carbohydrates, supplemented with a standardised complex carbohydrate (12.8 g) once blood glucose exceeded the target.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

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  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • A confirmed diagnosis of type 1 diabetes.
  • Absence of any concurrent chronic illnesses.
  • Absence of any physiological conditions precluding oral intake.
  • Absence of significant cognitive or developmental disorders that would impede capacity to participate in the study.
  • Aged between 7 and 18 years (as children under 7 years of age may experience difficulty consuming whole grain crackers).
  • Possession of a personal blood glucose monitor.
  • Absence of persistent hyperglycaemia.

Exclusion Criteria:

  • Days characterised by unusually high levels of routine exercise or physical activity.
  • The requirement for a second dose of simple carbohydrates (sugar cubes) during a single hypoglycaemia intervention (as consuming two doses may induce hyperglycaemia following the snack).
  • Experiencing multiple hypoglycaemic episodes within the same day.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control group
In the control group, the hypoglycaemia threshold was established in accordance with the ISPAD consensus guidelines. For this condition, the blood glucose threshold for hypoglycaemia intervention was defined as below 70 mg/dL;
Procedure: threshold 70 mg/dL
At these levels, children with type 1 diabetes were administered 0.3 g/kg of simple carbohydrates in the form of sugar cubes, and blood glucose was re-evaluated 15 minutes later. According to the ISPAD consensus guidelines, once blood glucose rises above 70 mg/dL following the administration of fast-acting carbohydrates, 10-15 g of complex carbohydrates should be given. As the complex carbohydrate source, the children were provided with four crackers (12.8 g) containing quinoa, black cumin, bran, and oats. Blood glucose levels were measured at 1 and 2 hours post-treatment to monitor for the occurrence of rebound hyperglycaemia.
Eksperimentel: Experiment group
In the experiment group, the routine clinical practice of the hospital was maintained. For this condition, the blood glucose threshold for hypoglycaemia intervention was defined as below 65 mg/dL
Procedure: threshold 65 mg/dL
At these levels, children with type 1 diabetes were administered 0.3 g/kg of simple carbohydrates in the form of sugar cubes, and blood glucose was re-evaluated 15 minutes later. According to the ISPAD consensus guidelines, once blood glucose rises above 70 mg/dL following the administration of fast-acting carbohydrates, 10-15 g of complex carbohydrates should be given. As the complex carbohydrate source, the children were provided with four crackers (12.8 g) containing quinoa, black cumin, bran, and oats. Blood glucose levels were measured at 1 and 2 hours post-treatment to monitor for the occurrence of rebound hyperglycaemia.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood glucose levels were measured at 1 and 2 hours post-treatment
Tidsramme: 1 and 2 hours post-treatment
Blood glucose levels were measured at 1 and 2 hours post-treatment to monitor for the occurrence of rebound hyperglycaemia.
1 and 2 hours post-treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marmara University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2024

Primær færdiggørelse (Faktiske)

25. februar 2025

Studieafslutning (Faktiske)

25. februar 2025

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19.11.2024/4619

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Kliniske forsøg med Diabetes mellitus, type 1

Kliniske forsøg med threshold 70 mg/dL

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