Diabetes Mellitus, Type 1
Conditions
Keywords
HbA1c, insulin pumps, closed-loop
Brief 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.
Interventions
DEVICESwitching to the Medtronic 780G insulin pump
Patients using a Medtronic 740G insulin pump will receive the 780G model for three months
Sponsors
ELIAS Emergency University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variations in HbA1c | Three months | Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in time in range (TIR) levels | Three months | changes in time in range (TIR) levels between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
| changes in time below range (TBR) | Three months | changes in time below range (TBR) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
| changes in insulin requirements | Three months | changes in insulin requirements between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
| changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization | Three months | changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
| changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores | Three months | changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Scores are transformed on a scale from 0 to 100. Higher scores = Better Quality of Life |
| changes in coefficient of variation (CV) | Three months | changes in coefficient of variation (CV) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Countries
Romania
Contacts
Primary ContactSorin Ioacara, MD, PhD
Outcome results
None listed