Smart pen could make insulin dosing easier for teens with diabetes
NCT ID NCT05515939
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This study tests whether a Bluetooth-enabled smart insulin pen, called InPen, can help teenagers with type 1 diabetes better control their blood sugar. The device helps calculate insulin doses and tracks injections, which may reduce errors. The trial involves 34 teens aged 13-21 who use multiple daily injections and have poor blood sugar control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- InPen smart insulin pen (device)
- What this could lead to
- If it works, this could give teens with type 1 diabetes a simpler way to manage insulin doses and improve blood sugar control.
- What could go wrong
- This is a small, early-stage study with only 34 participants, so results may not apply to everyone. The device is a tool, not a cure, and success depends on consistent use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients aged 13-21 years of age with Type 1 Diabetes who will be initiating treatment with the InPen insulin pen device
- Ages
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13 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients from 13-21 years of age (inclusive) at the time of enrollment. 2. Patients diagnosed with type 1 diabetes for more than 6 months. 3. Patients with uncontrolled T1D as defined by an elevated HbA1c \> 8% within the last 3 months prior to the start of the study. 4. Patients using multiple daily injections of insulin (MDI); basal- bolus regimen requiring three or more injections per day. 1. 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). 2. 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). 5. Completion of basic diabetes education program within first year of diagnosis including management of hyperglycemia and hypoglycemia. 6. Patients not actively using InPen (including discontinuation of the InPen for at least 12 weeks). Exclusion Criteria: 1. 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. 2. Patients who are unable to obtain insurance approval to cover the cost for the InPen device and insulin cartridges for the InPen. 3. Patients with T1D who are allergic to Humalog and Novolog insulin analogs. 4. Patients/caregivers who are unwilling to switch to the InPen device and/or insulin cartridges required for the use of the InPen device. 5. Patients who do not own a smartphone or tablet that is compatible with the InPen App.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Wayne State University
Detroit, Michigan, 48221, United States
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