Connected Pens for Diabetes Study

Study Overview
=================
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.

Official Title
-----------------
Connected Pens for Diabetes Study

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Connected insulin pen and smartphone app
* Device: Inactive connected insulin pen without smartphone app


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>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<br>* 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.<br>|
| Sham Comparator: Control Arm<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM time in range | 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 | Average change in HbA1c from Baseline to Month 3 compared between groups | 3 months | 
| 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 | 3 months | 
| 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 | 3 months | 
| 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 | 3 months | 
| 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. | 3 months | 
| 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. | 3 months | 
| 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. | 3 months | 
| 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. | 3 months |