Type 1 DiabetesNCT05036343
A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens
A study testing InPen® in people with Type 1 Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- InPen®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals between the ages of 13 and 21 years.
- Patients with Type 1 diabetes for at least 6 months
- Defined as either a c peptide <1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty
- Patients who currently receive insulin injections with a CGM.
- English speaking.
- Have access to a smart phone. on an insulin to carbohydrate ratio
Who cannot join
- Individuals less than 13
- Non-English speaking.
- No access to a smart phone.
- Intellectual disability that would impact their ability to utilize the technology
- Known pregnant women taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Smart Insulin Pens: A Randomized, Crossover Prospective Interventional Pilot Study Assessing the Effect on Glycemic Control and Diabetes Related Burdens
The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.
Read the detailed description
Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- InPen®
- Keywords
- Adolescents, Young Adults, Continuous Glucose monitoring (CGM)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InPen®Device
A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten.
| Study group | Role | What they receive |
|---|---|---|
| InPen® and CGM, then standard of care and CGM | Experimental | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will use the InPen® and CGM for the first 90 days then switch to standard of care with traditional insulin injections and CGM for 90 days. Receives: Device: InPen® |
| Standard of care and CGM, then InPen® and CGM | Experimental | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will receive standard of care with traditional insulin injections and CGM for first 90 days then switch to the InPen® and CGM for 90 days. Receives: Device: InPen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Time in Range
The percentage of time that glucose readings are in goal range (70-180 mg/dL)
Measured: 3 months
InPen® Missed Insulin Injections
Number of missed insulin injections after 30 and 90 days of InPen and CGM
Measured: 30 and 90 days
Change in Hemoglobin A1c
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Unit of measure = percent of glycated hemoglobin
Measured: Baseline, 3 months
Glucose
Mean glucose levels at 6 months. Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL
Measured: 3 months
Secondary outcomes (3)
Change in Diabetes Distress Scale Score
Measured using the Diabetes Distress Scale (DDS) which identifies 17 potential problem areas that people with diabetes may experience and asked subjects to rate their perceived degree of distressed during the past month; using a scale of 1 = "Not a problem at all", 6 = "A very serious problem." Total scores range from 17-102, lower scores indicating less distress and higher scores indicating more distress
Measured: Baseline, 3 months
Change in Transition Readiness
Mean change in transition readiness as measured by using the Transition Readiness Assessment Questionnaire (TRAQ). A 20-item questionnaire assessing the skill levels that are important for transition to adult health care; using a scale of 1 = "No, I do not know how", 5 = "Yes, I always do this when I need to." Total scores range from 20 - 100, lower scores indicating lower readiness and higher scores indicating greater readiness.
Measured: Baseline, 3 months
Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score
Measured using the Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment questionnaire. A 14-item questionnaire rating the confidence level for managing chronic conditions, medications and treatment; using a scale of 1 = "I am not at all confident", 5 = "I am very confident." Total scores range from 14-70, lower scores indicating lower confidence and higher scores indicating higher confidence.
Measured: Baseline, 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 Sep 2021
- Study start14 Sep 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana L. Creo, Mayo Clinic
- Investigators
- Ana Creo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036343
- Sponsor's protocol ID
- 21-004938
- Status last verified
- Dec 2023
- First submitted
- 2 Sep 2021
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Insulin Pens: A Randomized, Crossover Prospective Interventional Pilot Study Assessing the Effect on Glycemic Control and Diabetes Related Burdens
- ClinicalTrials.gov ID
- NCT05036343
- Acronym / sponsor ID
- 21-004938
- Conditions
- Type 1 Diabetes
- Keywords
- Adolescents, Young Adults, Continuous Glucose monitoring (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.
Detailed description
Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InPen® and CGM, then standard of care and CGM | Experimental | Device: InPen®Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will use the InPen® and CGM for the first 90 days then switch to standard of care with traditional insulin injections and CGM for 90 days. |
| Standard of care and CGM, then InPen® and CGM | Experimental | Device: InPen®Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will receive standard of care with traditional insulin injections and CGM for first 90 days then switch to the InPen® and CGM for 90 days. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Individuals between the ages of 13 and 21 years.
- Patients with Type 1 diabetes for at least 6 months
- Defined as either a c peptide <1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty
- Patients who currently receive insulin injections with a CGM.
- English speaking.
Key exclusion criteria (5 listed)
- Individuals less than 13
- Non-English speaking.
- No access to a smart phone.
- Intellectual disability that would impact their ability to utilize the technology
- Known pregnant women taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily)
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 |
|---|---|---|
| InPen®A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten. | Device | InPen® and CGM, then standard of care and CGM, Standard of care and CGM, then InPen® and CGM |
Primary outcome
Glucose Time in Range
Time frame: 3 months
The percentage of time that glucose readings are in goal range (70-180 mg/dL)
InPen® Missed Insulin Injections
Time frame: 30 and 90 days
Number of missed insulin injections after 30 and 90 days of InPen and CGM
Change in Hemoglobin A1c
Time frame: Baseline, 3 months
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Unit of measure = percent of glycated hemoglobin
Glucose
Time frame: 3 months
Mean glucose levels at 6 months. Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL
3 secondary outcomes
Change in Diabetes Distress Scale Score
Time frame: Baseline, 3 months
Change in Transition Readiness
Time frame: Baseline, 3 months
Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Ana Creo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InPen® in people with Type 1 Diabetes, run by Mayo Clinic 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jan 2024. 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. 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?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glucose Time in Range (time frame: 3 months). The study lists 4 primary outcomes in all. 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 2 Jan 2024.