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.
Email
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.
Email

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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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?