Changes in tissue glucose by diabetic ketoacidosis and obesity: Valid tissue glucose in diabetic ketoacidosis and in obesity?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012650

Enrollment

Registered

2017-07-04

Start date

2017-07-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10.90 E66.09

Interventions

Group 1: Type 1 diabetes patients with primary ketoacidosis during manifestation or secondary ketoacidosis (Age 5-18 years) Tissue glucose measurement by Freestyle libre and parallel blood glucose mea

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. In General: a. Signed informed consent 2. Type 1 Diabetes with ketoacidosis a. Ketoacidosis with pH 18 years b. BMI 18,5 – 25 kg/m2 4. Obese, healthy individuals a. Age > 18 years b. BMI >30 kg/m2

Exclusion criteria

Exclusion criteria: 1. In general: a. BMI < 18,5 kg/m2 (adults), < 3. age adjusted percentile (children, adolescents) b. Medication with salicylic acid or Vitamin C 2. Type 1 diabetes in ketoacidosis a. Mechanic ventilation or therapy with catecholamines b. Cerebral edema 3. Lean, healthy individuals a. Planned MRI during study 4. Obese healthy individuals a. Planned MRI during study

Design outcomes

Primary

Measure	Time frame
Concurrence of blood glucose and tissue glucose in patients with ketoacidosis by comparison of blood glucose and tissue glucose results that were mesured during the inpatient stay (up to 14 days). Concurrence of blood glucose and tissue glucose in lean and obese healthy individuals during 72 hours and during an oral glucose tolerance test by measurement of blood glucose and tissue glucose with the freestyle libre device.	—

Measure

Time frame

Concurrence of blood glucose and tissue glucose in patients with ketoacidosis by comparison of blood glucose and tissue glucose results that were mesured during the inpatient stay (up to 14 days). Concurrence of blood glucose and tissue glucose in lean and obese healthy individuals during 72 hours and during an oral glucose tolerance test by measurement of blood glucose and tissue glucose with the freestyle libre device.

—

Secondary

Measure	Time frame
• Interference of measurements by pH, Bicarbonate, Exsiccosis (weight loss, base excess), derangement of electrolytes, measured by blood gas anaylses and weighing during the inpatient stay. Timepoints are set by clinical necessity. • Delay by obesity, determined by repetitive measurement in set time frames (+30 minutes) after blood glucose measurements and during oral glucose tolerance testing.	—

Measure

Time frame

• Interference of measurements by pH, Bicarbonate, Exsiccosis (weight loss, base excess), derangement of electrolytes, measured by blood gas anaylses and weighing during the inpatient stay. Timepoints are set by clinical necessity. • Delay by obesity, determined by repetitive measurement in set time frames (+30 minutes) after blood glucose measurements and during oral glucose tolerance testing.

—

Countries

Germany

Contacts

Public ContactMichael Wurm

Pädiatrische Endokrinologie und Diabetologie, Klinik für Allgemeine Pädiatrie, Zentrum für Kinder- und Jugendmedizin

michael.wurm@uniklinik-freiburg.de0761-27044661

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026