Connected Pens for Diabetes Study

NCT ID: NCT03830216

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2019-11-12

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm

Study subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator.

Group Type: EXPERIMENTAL

Connected insulin pen and smartphone app

Intervention Type: DEVICE

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.

Control Arm

Study subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app.

Group Type: SHAM_COMPARATOR

Inactive connected insulin pen without smartphone app

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Companion Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Hoag Memorial Hospital Presbyterian

Locations

Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Countries

United States

Other Identifiers

CM 2018-01

Identifier Type: -

Identifier Source: org_study_id