- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03830216
Connected Pens for Diabetes Study (CUPID)
January 25, 2021 updated by: Companion Medical, Inc.
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Newport Beach, California, United States, 92663
- Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change in HbA1c
Time Frame: 3 months
|
Average change in HbA1c from Baseline to Month 3 compared between groups
|
3 months
|
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
|
3 months
|
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
|
3 months
|
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
|
3 months
|
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.
|
3 months
|
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.
|
3 months
|
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.
|
3 months
|
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.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in glycemic variability (CV and SD)
Time Frame: 3 months
|
3 months
|
Number of missed bolus doses and missed basal doses
Time Frame: 3 months
|
3 months
|
Number of SMBG measurements in participants not using CGM
Time Frame: 3 months
|
3 months
|
Number of insulin dose administrations
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Ahn, MD, Hoag Memorial Hospital Presbyterian
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2019
Primary Completion (Actual)
November 12, 2019
Study Completion (Actual)
November 12, 2019
Study Registration Dates
First Submitted
January 30, 2019
First Submitted That Met QC Criteria
February 1, 2019
First Posted (Actual)
February 5, 2019
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM 2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on Connected insulin pen and smartphone app
-
H. Lee Moffitt Cancer Center and Research InstituteNational Institute on Drug Abuse (NIDA)Recruiting
-
World BankDepartment for International Development, United Kingdom; Wits Reproductive... and other collaboratorsCompletedHIV Infections | Antiretroviral Therapy | Patient Compliance | Viral Load | Cell PhoneSouth Africa
-
Universidade Federal do ParanáCompletedAdolescent Behavior
-
Vanderbilt UniversityNovo Nordisk A/SActive, not recruiting
-
Hillerod Hospital, DenmarkPicterus ASRecruitingNeonatal Hyperbilirubinemia | Neonatal JaundiceBotswana
-
Calibra Medical, Inc.Northwestern University; University of Texas Southwestern Medical Center; Henry... and other collaboratorsCompletedFeasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily InjectionsDiabetes MellitusUnited States
-
Amalgam Rx, Inc.Kansas City Area Life Sciences Institute, Inc.; University of Kansas; LifeScanUnknown
-
University of PittsburghTerminated
-
Reuth Rehabilitation HospitalActive, not recruitingChronic Pain of Left Foot (Finding) | Chronic Pain of Right Foot (Finding)Israel
-
Nanfang Hospital of Southern Medical UniversityRecruitingInjection | Gestational Diabetes | Blood Glucose, High | Glycemic ControlChina