F3Z-MC-IOQY - ClinicalTrials.gov - NCT04484779
F3Z-MC-IOQY - ClinicalTrials.gov - NCT04484779
Key Requirements
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Participants must
Participants must have been diagnosed with type 1 diabetes (T1D) for at least 1 year or type 2 diabetes (T2D) for at least 6 months
Participants must be using insulin injection regimen of basal/bolus or basal only for 3 months prior to screening, which includes: (a). for bolus insulin (U-100) – a rapid-acting insulin analog (glulisine, lispro, or aspart) (b). for basal insulin – degludec (U-100 or U-200), detemir (U-100), or glargine (U-100 or U-300)
Participants with T2D may be on ≤ 3 anti-hyperglycemic medications in addition to insulin, including alpha-glucosidase inhibitors, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonist (GLP-1 RA; oral or injectable), meglitinides, metformin, sodium-glucose cotransporter-2 inhibitors (SGLTi-2), sulfonylureas, or thiazolidinediones consistent with product labeling
Participants with T1D must be on insulin only
Participants must be able to self-inject insulin dose (basal or basal/bolus) without assistance
If using Continuous Glucose Monitoring or Flash Glucose Monitoring device, participants must agree to stop use throughout duration of trial
Participants must NOT
Participants must not have experienced an episode of severe hypoglycemia within 3 months
Participants must not have hypoglycemia unawareness as judged by the investigator
Participants must not have had 1 or more emergency room visits or hospitalization due to poor glucose control within 3 months prior to screening
Trial Summary
Conditions the trial is for
Adult Type 1 Diabetes, Adult Type 2 Diabetes
What the trial is testing?
Integrated insulin management system
Could I receive a Placebo?
no
Enrollment Goal
50
Trial Dates
July 2020 - December 2020
Trial Phase
4
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Participants must
Participants must have been diagnosed with type 1 diabetes (T1D) for at least 1 year or type 2 diabetes (T2D) for at least 6 months
Participants must be using insulin injection regimen of basal/bolus or basal only for 3 months prior to screening, which includes: (a). for bolus insulin (U-100) – a rapid-acting insulin analog (glulisine, lispro, or aspart) (b). for basal insulin – degludec (U-100 or U-200), detemir (U-100), or glargine (U-100 or U-300)
Participants with T2D may be on ≤ 3 anti-hyperglycemic medications in addition to insulin, including alpha-glucosidase inhibitors, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonist (GLP-1 RA; oral or injectable), meglitinides, metformin, sodium-glucose cotransporter-2 inhibitors (SGLTi-2), sulfonylureas, or thiazolidinediones consistent with product labeling
Participants with T1D must be on insulin only
Participants must be able to self-inject insulin dose (basal or basal/bolus) without assistance
If using Continuous Glucose Monitoring or Flash Glucose Monitoring device, participants must agree to stop use throughout duration of trial
Participants must NOT
Participants must not have experienced an episode of severe hypoglycemia within 3 months
Participants must not have hypoglycemia unawareness as judged by the investigator
Participants must not have had 1 or more emergency room visits or hospitalization due to poor glucose control within 3 months prior to screening
Trial Summary
Conditions the trial is for
Adult Type 1 Diabetes, Adult Type 2 Diabetes
What the trial is testing?
Integrated insulin management system
Could I receive a Placebo?
no
Enrollment Goal
50
Trial Dates
July 2020 - December 2020
Trial Phase
4
Trial Locations
Hide locations not currently recruiting