Evaluating the InPen in Pediatric Type 1 Diabetes (EMPoWER)

• ClinicalTrials.gov Identifier: NCT05515939
• Recruitment Status: Enrolling by invitation
• First Posted: August 25, 2022
• Last Update Posted: October 3, 2022
• Sponsor: Wayne State University
• Information provided by (Responsible Party): Colleen Buggs-Saxton, MD, PhD, Wayne State University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Type 1 Diabetes	Device: InPen Insulin Pen

Study Design

• Study Type: Observational
• Estimated Enrollment: 34 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluating the Utility of the "sMart" InPen Wireless-Enabled System to impRove Glycemic Control in Pediatric Type 1 Diabetes (EMPoWER Study)
• Actual Study Start Date: September 9, 2022
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: January 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
InPen; Patients who will begin using the InPen device as per standard of care	Device: InPen Insulin Pen; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change in Diabetes Numeracy Test (DNT-14) [ Time Frame: Baseline and 24 weeks (end of study) ]
   Assessment test designed to investigate numeracy skills in patients with diabetes
2. Clinical Evaluation of Treatment [ Time Frame: 24 weeks (end of study) ]
   Questionnaire to assess usability, comfort with, and usefulness of the InPen and its app.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 13-21 years of age with Type 1 Diabetes who will be initiating treatment with the InPen insulin pen device

Criteria

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.

Contacts and Locations

Locations

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48221

Sponsors and Collaborators

Wayne State University

  Study Documents (Full-Text)

Documents provided by Colleen Buggs-Saxton, MD, PhD, Wayne State University:

Informed Consent Form  [PDF] May 18, 2022

More Information

• Responsible Party: Colleen Buggs-Saxton, MD, PhD, Associate Professor of Pediatrics, Wayne State University
• ClinicalTrials.gov Identifier: NCT05515939
• Other Study ID Numbers: WSU-12-2021
• First Posted: August 25, 2022
• Last Update Posted: October 3, 2022
• Last Verified: September 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Colleen Buggs-Saxton, MD, PhD, Wayne State University:

Type 1 Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs