Connected Pens for Diabetes Study (CUPID)
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|ClinicalTrials.gov Identifier: NCT03830216|
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: Connected insulin pen and smartphone app Device: Inactive connected insulin pen without smartphone app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, controlled treatment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Participants in the control arm will use a blinded device. All participants will be blinded to baseline time-in-range and HbA1c measures. Investigators will be blinded to professional CGM baseline time-in-range.|
|Official Title:||Connected Pens for Diabetes Study|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Treatment Arm
Study subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator.
Device: Connected insulin pen and smartphone app
The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is paired with a smartphone app with dose calculator.
Sham Comparator: Control Arm
Study subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app.
Device: Inactive connected insulin pen without smartphone app
The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is inactive and not paired with a smartphone app or dose calculator.
- CGM time in range [ Time Frame: 3 months ]Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
- Absolute change in HbA1c [ Time Frame: 3 months ]Average change in HbA1c from Baseline to Month 3 compared between groups
- Mean sensor glucose (mg/dL) [ Time Frame: 3 months ]Mean sensor glucose will be measured on the final blinded, professional CGM session performed at the end of the 3 month
- Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL) [ Time Frame: 3 months ]Percent of time spent in hypoglycemia from Baseline to Month 3 will be compared between groups
- Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL) [ Time Frame: 3 months ]Percent of time spent in hyperglycemia from Baseline to Month 3 will be compared between groups
- Change in patient reported outcomes - ADDQoL [ Time Frame: 3 months ]The Audit of Diabetes Dependent Quality of Life (ADDQoL) Questionnaire measures diabetes-specific quality of life. The 19 items measure the impact of diabetes on specific aspects of life and the importance of these aspects of life for quality of life.
- Change in patient reported outcomes - DTSQ [ Time Frame: 3 months ]The Diabetes Treatment Satisfaction Questionnaire (DTSQ) measures diabetes treatment satisfaction. The 8 items measure treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
- Change in patient reported outcomes - IDSS [ Time Frame: 3 months ]The Insulin Delivery Satisfaction Survey (IDSS) measures insulin delivery device satisfaction. The 14 items measure provides a comprehensive profile of sources of device satisfaction.
- Change in patient reported outcomes - HCS [ Time Frame: 3 months ]The Hypoglycemic Confidence Scale (HCS) Hypoglycemic measures the degree to which patients feel able, secure, and comfortable regarding their ability to avoid hypoglycemia.
- Change in glycemic variability (CV and SD) [ Time Frame: 3 months ]
- Number of missed bolus doses and missed basal doses [ Time Frame: 3 months ]
- Number of SMBG measurements in participants not using CGM [ Time Frame: 3 months ]
- Number of insulin dose administrations [ Time Frame: 3 months ]
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): NCT03830216
|Contact: Victoria Shainskyemail@example.com|
|United States, California|
|Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Michelle Sendejas 949-764-8065 Michelle.Sendejas@hoag.org|
|Principal Investigator: David T Ahn, MD|
|Principal Investigator:||David Ahn, MD||Hoag Memorial Hospital Presbyterian|