Connected Pens for Diabetes Study

NCT03830216 | Terminated FDA Device

• 1 other identifier: CM 2018-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• CGM time in range

  Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period

  3 months

Secondary Outcomes (8)

• Absolute change in HbA1c

  3 months

• Mean sensor glucose (mg/dL)

  3 months

• Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL)

  3 months

• Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL)

  3 months

• Change in patient reported outcomes - ADDQoL

  3 months

Other Outcomes (4)

• Change in glycemic variability (CV and SD)

  3 months

• Number of missed bolus doses and missed basal doses

  3 months

• Number of SMBG measurements in participants not using CGM

  3 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Control Arm

SHAM COMPARATOR

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

Interventions

Connected insulin pen and smartphone app 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.

Treatment Arm

Inactive connected insulin pen without smartphone app 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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Companion Medical, Inc.: lead

Study Sites (1)

Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Ahn, MD

  Hoag Memorial Hospital Presbyterian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled treatment

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 5, 2019
• Study Start: May 30, 2019
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)