Completed
A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes
F3Z-MC-IOQY - ClinicalTrials.gov - NCT04484779
The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone application. The application will be used to record and track diabetes-data related information.
How long will I be in the trial?
The study will last about 13 weeks and may include up to 6 visits.
Completed
A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes
F3Z-MC-IOQY - ClinicalTrials.gov - NCT04484779
The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone application. The application will be used to record and track diabetes-data related information.
How long will I be in the trial?
The study will last about 13 weeks and may include up to 6 visits.
Key Requirements
Age :
18+
Sex:
All
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.
Age
18+
Sex
All
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
Type 1 Diabetes, 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
Enter your postal code to find the nearest site
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.
Age
18+
Sex
All
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
Type 1 Diabetes, 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
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