Type 1 DiabetesEMPoWERNCT05515939
Evaluating the InPen in Pediatric Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Wayne State University at 1 site in United States.
Trial summary
Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. 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 Insulin Pen
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients aged 13-21 years of age with Type 1 Diabetes who will be initiating treatment with the InPen insulin pen device
Who may be able to join
- Patients from 13-21 years of age (inclusive) at the time of enrollment.
- Patients diagnosed with type 1 diabetes for more than 6 months.
- Patients with uncontrolled T1D as defined by an elevated HbA1c > 8% within the last 3 months prior to the start of the study.
- Patients using multiple daily injections of insulin (MDI); basal- bolus regimen requiring three or more injections per day.
- Basal insulin requirement: one or two dose per day of a long-acting insulin analog: insulin glargine U-100 (Lantus or Basaglar), insulin glargine U-300 (Toujeo), insulin detemir (Levemir), or insulin degludec (Tresiba).
- Bolus insulin requirement: three or more doses per day of a rapid-acting insulin analog: insulin lispro (Humalog or Admelog) or insulin aspart (Novolog or Fiasp).
- Completion of basic diabetes education program within first year of diagnosis including management of hyperglycemia and hypoglycemia.
- Patients not actively using InPen (including discontinuation of the InPen for at least 12 weeks).
Who cannot join
- Pediatric patients with T1D with health conditions that may impact glycemic control (e.g., uncontrolled hypothyroidism or hyperthyroidism or prolonged use (more than 2 weeks) of exogenous steroids), pregnancy, language barrier, or inability to obtain informed consent from patient and/or caregiver.
- Patients who are unable to obtain insurance approval to cover the cost for the InPen device and insulin cartridges for the InPen.
- Patients with T1D who are allergic to Humalog and Novolog insulin analogs.
- Patients/caregivers who are unwilling to switch to the InPen device and/or insulin cartridges required for the use of the InPen device.
- Patients who do not own a smartphone or tablet that is compatible with the InPen App.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Utility of the "sMart" InPen Wireless-Enabled System to impRove Glycemic Control in Pediatric Type 1 Diabetes (EMPoWER Study)
Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. Despite advances in insulin delivery systems, fewer black and Hispanic children compared to white children with T1D use insulin pumps. Therefore, most minority children with T1D in urban areas require multiple daily injections (MDI) of insulin which may put them at increased risk of poor glycemic control. Although several factors contribute to worsening glycemic control in adolescents with T1D, studies have shown that missing doses of insulin at mealtimes is a major factor.
Adolescents with T1D who use MDI with a basal-bolus regimen use formulas to calculate insulin doses that involve a four-step process. The complexity of determining insulin doses contributes to inaccuracies in both timing of doses and amount of insulin given, both of which can lead to hyperglycemia and hypoglycemia.
Read more
The InPen™ Smart Insulin Pen System (Medtronics) was approved by the FDA for children of all ages with T1D in June 2020. The InPen is a Bluetooth-enabled smart insulin pen that helps with management of insulin dosing and tracking via capture of rapid-acting insulin doses and tracking of insulin in the body through the use of its companion app (free on Apple iOS and Android). The app includes a bolus calculator, which can lead to more accurate insulin dosing, which may improve glycemic control.
The specific benefits of using the InPen include the following: simplifying insulin dose calculations, administering more accurate insulin doses, tracking insulin doses to help prevent hypoglycemia, providing reminders to administer insulin, and storing data in the InPen App that can be easily shared with diabetes healthcare teams to assist with adjusting insulin doses.
The goal of this study is to determine if use of the InPen will improve glycemic control and diabetes numeracy in adolescents with uncontrolled T1D living in urban areas.
- Conditions
- Type 1 Diabetes
- Being tested
- InPen Insulin Pen
- Keywords
- Type 1 Diabetes
- 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 Insulin PenDevice
The InPen is a reusable smart insulin pen for people living with diabetes. The device uses Bluetooth technology to send dose information to a mobile application. The InPen can be used to deliver insulin, help calculate insulin doses, and estimate carbohydrates for meals
| Study group | Role | What they receive |
|---|---|---|
| InPen | Patients who will begin using the InPen device as per standard of care Receives: Device: InPen Insulin Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c)
Change in mean hemoglobin A1c (HbA1c) among patients from baseline to 12- and 24 weeks after using the InPen device in diabetes management plan.
Measured: Baseline to 12 and 24 weeks (End of study)
Secondary outcomes (2)
Change in Diabetes Numeracy Test (DNT-14)
Assessment test designed to investigate numeracy skills in patients with diabetes
Measured: Baseline and 24 weeks (end of study)
Clinical Evaluation of Treatment
Questionnaire to assess usability, comfort with, and usefulness of the InPen and its app.
Measured: 24 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start9 Sep 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Buggs-Saxton, MD, PhD, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515939
- Sponsor's protocol ID
- WSU-12-2021
- Acronym
- EMPoWER
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Utility of the "sMart" InPen Wireless-Enabled System to impRove Glycemic Control in Pediatric Type 1 Diabetes (EMPoWER Study)
- ClinicalTrials.gov ID
- NCT05515939
- Acronym / sponsor ID
- EMPoWER / WSU-12-2021
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Aug 2022 (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.
Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. Despite advances in insulin delivery systems, fewer black and Hispanic children compared to white children with T1D use insulin pumps. Therefore, most minority children with T1D in urban areas require multiple daily injections (MDI) of insulin which may put them at increased risk of poor glycemic control. Although several factors contribute to worsening glycemic control in adolescents with T1D, studies have shown that missing doses of insulin at mealtimes is a major factor.
Adolescents with T1D who use MDI with a basal-bolus regimen use formulas to calculate insulin doses that involve a four-step process. The complexity of determining insulin doses contributes to inaccuracies in both timing of doses and amount of insulin given, both of which can lead to hyperglycemia and hypoglycemia.
The InPen™ Smart Insulin Pen System (Medtronics) was approved by the FDA for children of all ages with T1D in June 2020. The InPen is a Bluetooth-enabled smart insulin pen that helps with management of insulin dosing and tracking via capture of rapid-acting insulin doses and tracking of insulin in the body through the use of its companion app (free on Apple iOS and Android). The app includes a bolus calculator, which can lead to more accurate insulin dosing, which may improve glycemic control.
The specific benefits of using the InPen include the following: simplifying insulin dose calculations, administering more accurate insulin doses, tracking insulin doses to help prevent hypoglycemia, providing reminders to administer insulin, and storing data in the InPen App that can be easily shared with diabetes healthcare teams to assist with adjusting insulin doses.
The goal of this study is to determine if use of the InPen will improve glycemic control and diabetes numeracy in adolescents with uncontrolled T1D living in urban areas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InPen | – | Device: InPen Insulin PenPatients who will begin using the InPen device as per standard of care |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 13-21 years of age with Type 1 Diabetes who will be initiating treatment with the InPen insulin pen device
Key inclusion criteria (8 listed)
- Patients from 13-21 years of age (inclusive) at the time of enrollment.
- Patients diagnosed with type 1 diabetes for more than 6 months.
- Patients with uncontrolled T1D as defined by an elevated HbA1c > 8% within the last 3 months prior to the start of the study.
- Patients using multiple daily injections of insulin (MDI); basal- bolus regimen requiring three or more injections per day.
- Completion of basic diabetes education program within first year of diagnosis including management of hyperglycemia and hypoglycemia.
Key exclusion criteria (5 listed)
- Pediatric patients with T1D with health conditions that may impact glycemic control (e.g., uncontrolled hypothyroidism or hyperthyroidism or prolonged use (more than 2 weeks) of exogenous steroids), pregnancy, language barrier, or inability to obtain informed consent from patient and/or caregiver.
- Patients who are unable to obtain insurance approval to cover the cost for the InPen device and insulin cartridges for the InPen.
- Patients with T1D who are allergic to Humalog and Novolog insulin analogs.
- Patients/caregivers who are unwilling to switch to the InPen device and/or insulin cartridges required for the use of the InPen device.
- Patients who do not own a smartphone or tablet that is compatible with the InPen App.
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 Insulin PenThe InPen is a reusable smart insulin pen for people living with diabetes. The device uses Bluetooth technology to send dose information to a mobile application. The InPen can be used to deliver insulin, help calculate insulin doses, and estimate carbohydrates for meals | Device | InPen |
Primary outcome
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline to 12 and 24 weeks (End of study)
Change in mean hemoglobin A1c (HbA1c) among patients from baseline to 12- and 24 weeks after using the InPen device in diabetes management plan.
2 secondary outcomes
Change in Diabetes Numeracy Test (DNT-14)
Time frame: Baseline and 24 weeks (end of study)
Clinical Evaluation of Treatment
Time frame: 24 weeks (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Wayne State University 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 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Hemoglobin A1c (HbA1c) (time frame: Baseline to 12 and 24 weeks (End of study)). 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 20 Aug 2026.