UnknownPhase 4

Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus

Romania30 participantsStarted 2024-03-11

Plain-language summary

The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.

Who can participate

Age range7 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 7 years or older at baseline * Diagnosis of type 1 diabetes * Current use of a predictive low glucose suspend insulin pump (740G) * At least 30% of subjects must have an HbA1c \> 7,5% (58 mmol/mol) Exclusion Criteria: * Age \< 7 years or ≥ 18 years at baseline * Diabetes duration \< 1 year at baseline * HbA1c ≤ 7% (53 mmol/mol) * Not meeting the Romanian national standards for closed-loop insulin pump therapy * Other criteria deemed inappropriate by the principal investigator (to be documented)

What they're measuring

Variations in HbA1c

Timeframe: Three months

Trial details

NCT IDNCT06326489

SponsorELIAS Emergency University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

Contact for this trial

Sorin Ioacara, MD, PhD

0040213161600 drsorin@yahoo.com

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials