Type 1 Diabetes
Conditions
Brief summary
This is an exploratory, single-center retrospective cohort real-world study comparing safety and efficacy of Fiasp® versus NovoRapid® when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus
Detailed description
This study evaluates the effectiveness and safety of faster-acting insulin aspart (Fiasp®) compared with rapid-acting insulin analogues (insulin aspart or insulin lispro) in children and adolescents with type 1 diabetes mellitus using insulin pump therapy. The study is a single-center retrospective cohort study including real-world clinical data from pediatric patients followed at the Pediatric Diabetes Outpatient Clinic of the 1st Pediatric Department of the Aristotle University of Thessaloniki, at Ippokratio General Hospital. Clinical and continuous glucose monitoring data were collected from medical records during routine clinical follow-up. Patients were treated with continuous subcutaneous insulin infusion using insulin pumps equipped with continuous glucose monitoring systems. The primary objective was to evaluate glycemic control using continuous glucose monitoring metrics, with particular emphasis on time in range (70-180 mg/dL). Secondary outcomes included time spent in hypoglycemia (\<70 mg/dL), time spent in hyperglycemia (\>180 mg/dL and \>250 mg/dL), glycemic variability, total daily insulin dose, basal and bolus insulin distribution, and other pump-related parameters. Comparisons were performed between patients receiving faster-acting insulin aspart and those receiving rapid-acting insulin analogues during routine clinical care.
Interventions
Faster-acting insulin aspart used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.
DRUGRapid-acting insulin analogues (insulin aspart or insulin lispro)
Rapid-acting insulin analogues used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained by parents or legal caregivers before any trial-related activities. 2. Any age, age ≥ 2 years and age \<18 years at the time of signing informed consent 3. Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study 4. Using the Medtronic MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial. 5. Ability and willingness to use the same insulin infusion sets throughout the trial 6. Using the same insulin for at least 30 days prior to screening 7. HbA1c \< 9.0% as assessed by local laboratory at screening 8. Ability and willingness to adhere to the protocol including performing SMBG (Self Monitoring Blood Glucose) profiles, attending visits, uploading pump and sensor data to the CareLink platform
Exclusion criteria
1. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies 2. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening 3. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial 4. Any diabetic complication including renal disease, retinopathy, etc 5. History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening 6. Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-hour glucose levels on Novorapid | Weeks 1 to 4 | ost-prandial 1-hour glucose levels on Novorapid® when used in the MiniMed 640G pump in children with type 1 diabetes. |
| 1-hour glucose levels on Fiasp | Weeks 1 to 4 | ost-prandial 1-hour glucose levels on Fiasp® when used in the MiniMed 640G pump in children with type 1 diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion events in Novorapid | Weeks 1 to 4 | Number of occlusion events during Novorapid® use |
| Half-hour glucose levels on Fiasp | Weeks 1 to 4 | ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed |
| Half-hour glucose levels on Novorapid | Weeks 1 to 4 | ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed |
| 2 hours glucose levels on Fiasp | Weeks 1 to 4 | ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed |
| 2 hours glucose levels on Novorapid | Weeks 1 to 4 | ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed |
| Time in Range in Fiasp | Weeks 1 to 4 | Percent of time spent within 70-180 mg/dl during Fiasp® use |
| Time in Range in Novorapid | Weeks 1 to 4 | Percent of time spent within 70-180 mg/dl during Novorapid® use |
| Hypoglycemia in Fiasp | Weeks 1 to 4 | Percent of time spent below 70mg mg/dl during Fiasp® use |
| Hypoglycemia in Novorapid | Weeks 1 to 4 | Percent of time spent below 70mg mg/dl during Novorapid® use |
| Total Daily Dose in Fiasp | Weeks 1 to 4 | Units of insulin used per day during Fiasp® use |
| Total Daily Dose in Novorapid | Weeks 1 to 4 | Units of insulin used per day during Novorapid® use |
| Basal/Bolus in Fiasp | Weeks 1 to 4 | Units of insulin used per basal/bolus day during Fiasp® use |
| Basal/Bolus in Novorapid | Weeks 1 to 4 | Units of insulin used per basal/bolus day during Novorapid® use |
| eHbA1c in Fiasp | Weeks 1 to 4 | Estimated HbA1c levels during Fiasp® use |
| eHbA1c in Novorapid | Weeks 1 to 4 | Estimated HbA1c levels during Novorapid® use |
| Incidence of infusion sites reactions in Novorapid | Weeks 1 to 4 | Number of reactions involving infusion sites during Fiasp® use |
| Incidence of infusion sites reactions in Fiasp | Weeks 1 to 4 | Number of reactions involving infusion sites during Fiasp® use |
| Occlusion events in Fiasp | Weeks 1 to 4 | Number of occlusion events during Fiasp® use |
Countries
Greece
Outcome results
None listed