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Trial record 3 of 16 for:    g-pump

Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor

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ClinicalTrials.gov Identifier: NCT04149262
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Athanasios Christoforidis, Aristotle University Of Thessaloniki

Brief Summary:
This is an exploratory, single-center, open label, randomized, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoRapid® when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Fiasp Drug: Novorapid Device: 640G pump Phase 4

Detailed Description:

This study is designed to compare Fiasp® to NovoRapid® in children with T1DM wearing MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter in terms of glycemic control with a focus on post-prandial ½-hour and 1-hour plasma glucose levels. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.

Half, randomized subjects will have a 4 weeks screening period using NovoRapid® and then 4 weeks treatment period with Fiasp® whereas the rest of the participants will start the trial period with 4 weeks using Fiasp® followed by 4 weeks in NovoRapid®.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single-center, Randomized, Cross-over Trial Comparing the Efficacy and Safety of Faster-acting Insulin Aspart (Fiasp®) Compared to Insulin Aspart (NovoRapid)® Used in the Medtronic MiniMed 640G Insulin Pump Equipped With Sensor
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 15, 2020


Arm Intervention/treatment
Active Comparator: Fiasp/Novorapid
4 weeks on Fiasp® then crossover to 4 weeks on NovoRapid® in subjects on the MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
Drug: Fiasp
Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter

Drug: Novorapid
Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter

Device: 640G pump
MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link

Active Comparator: Novorapid/Fiasp
4 weeks on NovoRapid® then crossover to 4 weeks on Fiasp® in subjects on the MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
Drug: Fiasp
Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter

Drug: Novorapid
Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter

Device: 640G pump
MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link




Primary Outcome Measures :
  1. 1-hour glucose levels on Fiasp [ Time Frame: 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.

  2. 1-hour glucose levels on Novorapid [ Time Frame: 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.


Secondary Outcome Measures :
  1. Half-hour glucose levels on Fiasp [ Time Frame: Weeks 1 to 4 ]
    ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed

  2. Half-hour glucose levels on Novorapid [ Time Frame: Weeks 1 to 4 ]
    ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed

  3. 2 hours glucose levels on Fiasp [ Time Frame: Weeks 1 to 4 ]
    ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed

  4. 2 hours glucose levels on Novorapid [ Time Frame: Weeks 1 to 4 ]
    ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed

  5. Time in Range in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Percent of time spent within 70-180 mg/dl during Fiasp® use

  6. Time in Range in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Percent of time spent within 70-180 mg/dl during Novorapid® use

  7. Hypoglycemia in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Percent of time spent below 70mg mg/dl during Fiasp® use

  8. Hypoglycemia in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Percent of time spent below 70mg mg/dl during Novorapid® use

  9. Total Daily Dose in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Units of insulin used per day during Fiasp® use

  10. Total Daily Dose in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Units of insulin used per day during Novorapid® use

  11. Basal/Bolus in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Units of insulin used per basal/bolus day during Fiasp® use

  12. Basal/Bolus in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Units of insulin used per basal/bolus day during Novorapid® use

  13. eHbA1c in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Estimated HbA1c levels during Fiasp® use

  14. eHbA1c in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Estimated HbA1c levels during Novorapid® use

  15. Incidence of infusion sites reactions in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Number of reactions involving infusion sites during Fiasp® use

  16. Incidence of infusion sites reactions in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Number of reactions involving infusion sites during Fiasp® use

  17. Occlusion events in Fiasp [ Time Frame: Weeks 1 to 4 ]
    Number of occlusion events during Fiasp® use

  18. Occlusion events in Novorapid [ Time Frame: Weeks 1 to 4 ]
    Number of occlusion events during Novorapid® use



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149262


Locations
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Greece
Aristotle University of Thessaloniki
Thessaloniki, Greece, 54246
Sponsors and Collaborators
Aristotle University Of Thessaloniki
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Responsible Party: Athanasios Christoforidis, Assistant Professor in Pediatric Endocrinology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04149262    
Other Study ID Numbers: AUTH-AC-1
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs