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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
Sponsor:
Information provided by (Responsible Party):
Companion Medical, Inc.

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.

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

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Absolute change in HbA1c [ Time Frame: 3 months ]
    Average change in HbA1c from Baseline to Month 3 compared between groups

  2. 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. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. Change in glycemic variability (CV and SD) [ Time Frame: 3 months ]
  2. Number of missed bolus doses and missed basal doses [ Time Frame: 3 months ]
  3. Number of SMBG measurements in participants not using CGM [ Time Frame: 3 months ]
  4. Number of insulin dose administrations [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The participant is ≥ 18 years of age
  2. 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.
  3. Glycated hemoglobin (HbA1c) ≥ 7.5%).
  4. The participant is a current iPhone user for over 30 days.
  5. Participant adjusts meal insulin doses based on carbohydrate content of meals.
  6. The participant is fluent in the English language.
  7. The participant and the investigator understand participant obligations and agree that the participant is willing and able to complete the study visits.
  8. Patients prandial insulin need must be <30 U per meal.

Exclusion Criteria:

  1. The participant has been using unblinded CGM for less than 6 months.
  2. The participant uses pre-mixed insulin.
  3. Current use of a smart insulin pen.
  4. Use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose results
  5. Used systemic oral or inhaled steroids for more than 7 days within the last 3 months
  6. Oral anti-diabetic agents, with the exception of metformin
  7. Injectable anti-diabetic agents other than insulin
  8. The participant is legally blind or has below specified best-corrected vision level.
  9. Diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion)
  10. The participant is pregnant, lactating, or plans to become pregnant in the next 6 months.
  11. The participant is currently participating in another clinical study that may preclude the participant from meeting the obligations of this study.
  12. 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.

Information from the National Library of Medicine

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


Contacts
Contact: Victoria Shainsky 858-603-3139 vshainsky@companionmedical.com

Locations
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         
Sponsors and Collaborators
Companion Medical, Inc.
Investigators
Principal Investigator: David Ahn, MD Hoag Memorial Hospital Presbyterian

Responsible Party: Companion Medical, Inc.
ClinicalTrials.gov Identifier: NCT03830216     History of Changes
Other Study ID Numbers: CM 2018-01
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs