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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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780G

Patients in this arm will receive a 780G for three months.

Group Type EXPERIMENTAL

Switching to the Medtronic 780G insulin pump

Intervention Type DEVICE

Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

Interventions

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Switching to the Medtronic 780G insulin pump

Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No