Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03774069
Eligibility Criteria:
Inclusion Criteria:
1. Subject with type 1 diabetes (\>1 yr diagnosis)
2. Age- 6-30 years old
3. HbA1c equals or above 7% and equals or below 10%
4. Insulin infusion pump CSII (Continuous Subcutaneous Inulin Infusion) therapy for at least 4 months and current treatment with one of the following pumps: Omnipod Insulet (Bedford, MA), Medtronic Minimed Veo insulinPump (MMT-754, MMT-554), Medtronic 640G or Animas.
5. BMI below 30 kg/m\^2
6. Patients willing to follow study instructions (willing to measure capillary blood glucose as required by their glucose sensor for calibration and use the bolus- calculator feature of the pump)
7. Patients are required to have minimum computer skills and understanding of navigating the internet.
8. Patients are required to know basic English.
9. Patients willing to use glucose sensor for study duration.
10. Patients will have to have a smartphone (Apple or Android) or PC with email account.
Exclusion Criteria:
1. An episode of diabetic ketoacidosis within the month prior to study entry
2. Any significant diseases/ conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety.
3. Current participation in any other interventional study.
4. Known or suspected allergy to trial products such as adhesives, tapes, needles.
5. Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
6. Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine society as follows: Severe hypoglycaemia is an event requiring assistance of another person (due to change in mental status) to actively administer carbohydrates, glucagon, or take othe corrective actions.
7. Current use of the following medications: medications that are use to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
8. Hypoglycemia unawareness
9. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus.
* Subject has unstable or rapidly progressive renal disease or is receiving dialysis.
* Subject has active proliferative retinopathy.
* Active gastroparesis
10. Patient suffers from eating disorder. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03774069
Study Brief:
Protocol Section:
NCT03774069