Connected Pens for Diabetes Study

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03830216

Run by

Companion Medical, Inc.

People needed

21

Starts

2019-05-30

Expected to finish

2019-11-12

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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