Clinical trial NCT03830216: Connected Pens for Diabetes Study
Official title: Connected Pens for Diabetes Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Companion Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled treatment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CGM time in range
timeFrame: 3 months
Secondary outcomes:
measure: Absolute change in HbA1c
timeFrame: 3 months
measure: Mean sensor glucose (mg/dL)
timeFrame: 3 months
measure: Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL)
timeFrame: 3 months
measure: Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL)
timeFrame: 3 months
measure: Change in patient reported outcomes - ADDQoL
timeFrame: 3 months
measure: Change in patient reported outcomes - DTSQ
timeFrame: 3 months
measure: Change in patient reported outcomes - IDSS
timeFrame: 3 months
measure: Change in patient reported outcomes - HCS
timeFrame: 3 months
Other outcomes:
measure: Change in glycemic variability (CV and SD)
timeFrame: 3 months
measure: Number of missed bolus doses and missed basal doses
timeFrame: 3 months
measure: Number of SMBG measurements in participants not using CGM
timeFrame: 3 months
measure: Number of insulin dose administrations
timeFrame: 3 months
Locations:
city: Newport Beach
country: United States
facility: Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: David Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: