Insulearn Feasibility With MDI (InsuLearn)

Feasibility of a Bolus Calculator Without Carbohydrate Counting in T1D Patients Under MDI Therapy: A Supervised Randomized Controlled Trial

This is a 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: InsuLearn

Detailed Description

Following recruitment and screening, 12 participants will be randomized to either the InsuLearn→UC or the UC→InsuLearn sequence. Participants will be trained in the use of CGM (Dexcom G6 or Guardian™ 4), smart insulin pen (SIP, InPen™, Medtronic) and the InPen™ bolus calculator phone application. The InPen™ application will be set to the "meal estimation" mode where the user can select the meal category: if it is a breakfast/lunch/dinner/snack and if it has low/med/high carb amount. During the one-month data collection period, participants will be asked to use the InPen™ app to log and deliver their insulin doses. Before the hotel admission, InsuLearn will analyze the collected data to learn a new optimized insulin dose for each meal category. InsuLearn will generate a report of suggested new insulin doses that will be reviewed, approved, or changed by the study physician as needed. In the 24-h supervised interventions (hotel admission), the participant will consume three standardized meals, a med-carb lunch, a high-carb dinner, and low-carb breakfast. The insulin dose delivered in each admission will be either calculated by participants as per their UC or is as provided by the InsuLearn approved report. The two interventions are combined into a 2-day admission without a washout period.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasmeen Dhillon; Phone Number: (434) 466-7942; Email: jkd9ud@uvahealth.org
• Study Contact Backup: Name: Viola Holmes, RD, CDCES; Phone Number: (434) 249-6251; Email: vjf7j@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903-2981
      • University of Virginia Center for Diabetes Technology
      • Sub-Investigator: Ralf Nass, MD
      • Contact: Anas Fathi, PhD; Phone Number: 434-982-6483; Email: fwt9vd@virginia.edu
      • Sub-Investigator: Marc Breton, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18.0 years old at time of consent.
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year.
3. Hemoglobin A1c (HbA1c) between 7.0% - 10.0%.
4. Currently using insulin under multiple daily injections (MDI) therapy for at least six months.
5. Poor carbohydrate counting, based on their score on the AdultCarbQuiz (a score lower of 33/43).
6. Willingness to wear the study continuous glucose monitor (CGM) during the duration of the study.
7. Access to the internet and willingness to upload data during the study as needed.
8. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
9. Investigator has confidence that the subject can successfully operate all study devices and can adhere to the protocol.

Participant Exclusion Criteria

1. NPH (neutral protamine hagedorn) insulin
2. Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
3. Currently being treated for a seizure disorder.

4. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:

   1. Inpatient psychiatric treatment in the past 6 months
   2. Presence of a known adrenal disorder
   3. Abnormal liver function test results (Transaminase >3 times the upper limit of normal)
   4. Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2).
   5. Active gastroparesis requiring medical therapy.
   6. Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L).
   7. Abuse of alcohol or recreational drugs
   8. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
   9. Uncontrolled arterial hypertension (Resting diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg).
   10. Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
5. Currently pregnant or intent to become pregnant during the trial.
6. Currently breastfeeding.
7. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol.
8. Participation in another pharmaceutical or device trial at the time of enrolment or during the study.
9. Currently taking non-insulin glucose-lowering agent during the trial (including GLP-1 receptor agonists, pramlintide, and SGLT2 inhibitors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: InsuLearn→Usual Care; During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by the InsuLearn, MD approved, report. The second 24 hours of the hotel admission (visit 7), participants will use their usual care method to calculate their insulin dose.	Device: InsuLearn; InsuLearn is an artificial intelligence (AI)-algorithm that analyses collected participants data: CGM, insulin, and meal categories to learn the optimal insulin dose. InsuLearn will run offline in a study laptop to generate the optimal insulin dose for each meal category. The algorithm will generate an ambulatory glucose profile (AGP) report with new settings for the InPen™ meal estimation bolus calculator. The study physician will review the report and the algorithm recommendations. The study physician can accept or modify the algorithm recommendations as per his judgment. The new settings will be used during the intervention admission.
Active Comparator: Usual Care→InsuLearn; During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by their usual care method. The second 24 hours of the hotel admission (visit 7), participants will use the InsuLearn, MD approved, report to calculate their insulin dose.	Device: InsuLearn; InsuLearn is an artificial intelligence (AI)-algorithm that analyses collected participants data: CGM, insulin, and meal categories to learn the optimal insulin dose. InsuLearn will run offline in a study laptop to generate the optimal insulin dose for each meal category. The algorithm will generate an ambulatory glucose profile (AGP) report with new settings for the InPen™ meal estimation bolus calculator. The study physician will review the report and the algorithm recommendations. The study physician can accept or modify the algorithm recommendations as per his judgment. The new settings will be used during the intervention admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Low blood glucose index (LBGI)	Six hours after the three meals

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Medtronic; DexCom, Inc.
• Investigators: Principal Investigator: Anas Fathi, PhD, University of Virginia Center for Diabetes Technology

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Dexcom CGM; InPen
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 231610

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes