Back to resultsConnected Pens for Diabetes Study (CUPID)
Primary Purpose
Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connected insulin pen and smartphone app
Inactive connected insulin pen without smartphone app
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- The participant is ≥ 18 years of age
- The participant has Type 1 OR Type 2 diabetes and is being treated with intensive insulin therapy via injection for ≥ 3 months. Intensive insulin therapy is defined as at least one long acting insulin dose and two or more short acting insulin doses per day.
- Glycated hemoglobin (HbA1c) ≥ 7.5%).
- The participant is a current iPhone user for over 30 days.
- Participant adjusts meal insulin doses based on carbohydrate content of meals.
- The participant is fluent in the English language.
- The participant and the investigator understand participant obligations and agree that the participant is willing and able to complete the study visits.
- Patients prandial insulin need must be <30 U per meal.
Exclusion Criteria:
- The participant has been using unblinded CGM for less than 6 months.
- The participant uses pre-mixed insulin.
- Current use of a smart insulin pen.
- Use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose results
- Used systemic oral or inhaled steroids for more than 7 days within the last 3 months
- Oral anti-diabetic agents, with the exception of metformin
- Injectable anti-diabetic agents other than insulin
- The participant is legally blind or has below specified best-corrected vision level.
- Diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion)
- The participant is pregnant, lactating, or plans to become pregnant in the next 6 months.
- The participant is currently participating in another clinical study that may preclude the participant from meeting the obligations of this study.
- The participant has any additional condition(s) (medical, social, or psychosocial) that in the investigator's opinion would warrant exclusion from the study or prevent the participant from completing or complying with the study requirements.
Sites / Locations
- Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment Arm
Control Arm
Arm Description
Study subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator.
Study subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app.
Outcomes
Primary Outcome Measures
CGM time in range
Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
Secondary Outcome Measures
Absolute change in HbA1c
Average change in HbA1c from Baseline to Month 3 compared between groups
Mean sensor glucose (mg/dL)
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)
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)
Percent of time spent in hyperglycemia from Baseline to Month 3 will be compared between groups
Change in patient reported outcomes - ADDQoL
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
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
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
The Hypoglycemic Confidence Scale (HCS) Hypoglycemic measures the degree to which patients feel able, secure, and comfortable regarding their ability to avoid hypoglycemia.
Full Information
NCT ID
NCT03830216
First Posted
January 30, 2019
Last Updated
January 25, 2021
Sponsor
Companion Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03830216
Brief Title
Connected Pens for Diabetes Study
Acronym
CUPID
Official Title
Connected Pens for Diabetes Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Selective inclusion/exclusion criteria led to low enrollment which was not viable for the sponsor and site.
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Companion Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to evaluate the impact of a wireless smart insulin pen and smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated diabetes mellitus patients after 3 months of use.
Detailed Description
The study is a prospective, randomized, controlled treatment design. The study device will be used for multiple daily injection (MDI) therapy of insulin. The participant will interact with the study device in the uncontrolled environment of the participant's daily life. The study protocol is designed to yield meaningful data to determine clinical and psychosocial benefits of using the study device. The study will evaluate the study device as an intervention versus a control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled treatment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Study subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
Study subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app.
Intervention Type
Device
Intervention Name(s)
Connected insulin pen and smartphone app
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Inactive connected insulin pen without smartphone app
Intervention Description
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.
Primary Outcome Measure Information:
Title
CGM time in range
Description
Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Absolute change in HbA1c
Description
Average change in HbA1c from Baseline to Month 3 compared between groups
Time Frame
3 months
Title
Mean sensor glucose (mg/dL)
Description
Mean sensor glucose will be measured on the final blinded, professional CGM session performed at the end of the 3 month
Time Frame
3 months
Title
Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL)
Description
Percent of time spent in hypoglycemia from Baseline to Month 3 will be compared between groups
Time Frame
3 months
Title
Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL)
Description
Percent of time spent in hyperglycemia from Baseline to Month 3 will be compared between groups
Time Frame
3 months
Title
Change in patient reported outcomes - ADDQoL
Description
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.
Time Frame
3 months
Title
Change in patient reported outcomes - DTSQ
Description
The Diabetes Treatment Satisfaction Questionnaire (DTSQ) measures diabetes treatment satisfaction. The 8 items measure treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Time Frame
3 months
Title
Change in patient reported outcomes - IDSS
Description
The Insulin Delivery Satisfaction Survey (IDSS) measures insulin delivery device satisfaction. The 14 items measure provides a comprehensive profile of sources of device satisfaction.
Time Frame
3 months
Title
Change in patient reported outcomes - HCS
Description
The Hypoglycemic Confidence Scale (HCS) Hypoglycemic measures the degree to which patients feel able, secure, and comfortable regarding their ability to avoid hypoglycemia.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in glycemic variability (CV and SD)
Time Frame
3 months
Title
Number of missed bolus doses and missed basal doses
Time Frame
3 months
Title
Number of SMBG measurements in participants not using CGM
Time Frame
3 months
Title
Number of insulin dose administrations
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant is ≥ 18 years of age
The participant has Type 1 OR Type 2 diabetes and is being treated with intensive insulin therapy via injection for ≥ 3 months. Intensive insulin therapy is defined as at least one long acting insulin dose and two or more short acting insulin doses per day.
Glycated hemoglobin (HbA1c) ≥ 7.5%).
The participant is a current iPhone user for over 30 days.
Participant adjusts meal insulin doses based on carbohydrate content of meals.
The participant is fluent in the English language.
The participant and the investigator understand participant obligations and agree that the participant is willing and able to complete the study visits.
Patients prandial insulin need must be <30 U per meal.
Exclusion Criteria:
The participant has been using unblinded CGM for less than 6 months.
The participant uses pre-mixed insulin.
Current use of a smart insulin pen.
Use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose results
Used systemic oral or inhaled steroids for more than 7 days within the last 3 months
Oral anti-diabetic agents, with the exception of metformin
Injectable anti-diabetic agents other than insulin
The participant is legally blind or has below specified best-corrected vision level.
Diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion)
The participant is pregnant, lactating, or plans to become pregnant in the next 6 months.
The participant is currently participating in another clinical study that may preclude the participant from meeting the obligations of this study.
The participant has any additional condition(s) (medical, social, or psychosocial) that in the investigator's opinion would warrant exclusion from the study or prevent the participant from completing or complying with the study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ahn, MD
Organizational Affiliation
Hoag Memorial Hospital Presbyterian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Connected Pens for Diabetes Study
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