Diabetes MellitusCUPIDNCT03830216
Connected Pens for Diabetes Study
A study testing Connected insulin pen and smartphone app and Inactive connected insulin pen without smartphone app in people with Diabetes Mellitus, run by Companion Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Connected insulin pen and smartphone app and Inactive connected insulin pen without smartphone app
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
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.
Read the 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
- Being tested
- Connected insulin pen and smartphone app, Inactive connected insulin pen without smartphone app
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected insulin pen and smartphone appDevice
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.
Inactive connected insulin pen without smartphone appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Inactive connected insulin pen without smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM time in range
Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
Measured: 3 months
Secondary outcomes (8)
Absolute change in HbA1c
Average change in HbA1c from Baseline to Month 3 compared between groups
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start30 May 2019
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Why it stopped: Selective inclusion/exclusion criteria led to low enrollment which was not viable for the sponsor and site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Companion Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Ahn, MD, Principal investigator, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830216
- Sponsor's protocol ID
- CM 2018-01
- Acronym
- CUPID
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connected Pens for Diabetes Study
- ClinicalTrials.gov ID
- NCT03830216
- Acronym / sponsor ID
- CUPID / CM 2018-01
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Selective inclusion/exclusion criteria led to low enrollment which was not viable for the sponsor and site.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Companion Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Connected insulin pen and smartphone appStudy subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator. |
| Control Arm | Sham comparator | Device: Inactive connected insulin pen without smartphone appStudy subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connected insulin pen and smartphone appThe 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. | Device | Treatment Arm |
| Inactive connected insulin pen without smartphone appThe 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. | Device | Control Arm |
Primary outcome
CGM time in range
Time frame: 3 months
Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
8 secondary outcomes
Absolute change in HbA1c
Time frame: 3 months
Mean sensor glucose (mg/dL)
Time frame: 3 months
Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL)
Time frame: 3 months
Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL)
Time frame: 3 months
Change in patient reported outcomes - ADDQoL
Time frame: 3 months
Change in patient reported outcomes - DTSQ
Time frame: 3 months
Change in patient reported outcomes - IDSS
Time frame: 3 months
Change in patient reported outcomes - HCS
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Selective inclusion/exclusion criteria led to low enrollment which was not viable for the sponsor and site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ahn, MD principal investigator
Hoag Memorial Hospital Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected insulin pen and smartphone app and Inactive connected insulin pen without smartphone app in people with Diabetes Mellitus, run by Companion Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Selective inclusion/exclusion criteria led to low enrollment which was not viable for the sponsor and site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM time in range (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.