Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study

NCT04320069 | Completed Results DMC FDA Device

• 1 other identifier: G200018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.

Conditions

Type 1 Diabetes

Keywords

T1D; Omnipod

Outcome Measures

Primary Outcomes (2)

• Percentage of Time <70 mg/dL

  Glucose metric from continuous glucose monitoring system (CGM)

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

• Percentage of Time >180 mg/dL

  Glucose metric from continuous glucose monitoring system (CGM)

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

Secondary Outcomes (15)

• Mean Glucose

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

• Percentage of Time <54 mg/dL

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

• Percentage of Time ≥ 250 mg/dL

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

• Percentage of Time ≥ 300 mg/dL

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

• Percentage of Time in Range 70-180 mg/dL

  Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)

Study Arms (1)

Omnipod Horizon™ Automated Glucose Control System

EXPERIMENTAL

All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.

Device: Omnipod Horizon™ Automated Glucose Control System

Interventions

Omnipod Horizon™ Automated Glucose Control System DEVICE

Omnipod Horizon™ Automated Glucose Control System use in Manual Mode

Omnipod Horizon™ Automated Glucose Control System

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of consent/assent 2-70 years
• Subjects aged \< 18 years must be living with parent/legal guardian
• Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
• Must be a current Omnipod user, or have used an Omnipod in the past
• Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
• Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra
• Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality
• Must be willing to use the Omnipod Horizon™ bolus calculator without a connected CGM for the first 7-days of Manual Mode (Phase 1) while manually entering BG values to deliver boluses
• Must be willing to use the Omnipod Horizon™ bolus calculator with a connected CGM for the last 7-days of Manual Mode (Phase 2) using the CGM-informed bolus calculator to deliver boluses
• Willing to wear the system continuously throughout the study
• For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C \<10%
• Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (except for the Dexcom Follow App)
• Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)
• Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from subjects aged \< 18 years per State requirements.
• For subjects aged 2-5.9 years of age, parents or trained caregivers agree to be physically present during the decision and delivery of insulin boluses for this age group, as well as agree to be available for glucose monitoring and treatment during the 4-hour post bolus period.

You may not qualify if:

• A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
• History of severe hypoglycemia in the past 6 months
• History of DKA in the past 6 months, unrelated to an intercurrent illness or infusion set failure
• Plans to receive blood transfusion over the course of the study
• Currently diagnosed with anorexia nervosa or bulimia
• Acute or chronic kidney disease or currently on hemodialysis
• History of adrenal insufficiency
• Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study
• Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• Plans to use insulin other than U-100 insulin intended for use in the study device during the study
• Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
• Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months
• Clinical signs of hypothyroidism and hyperthyroidism
• Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
• Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of the pivotal study after study pause.

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (4)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• Pinsker JE, Church MM, Brown SA, Voelmle MK, Bode BW, Narron B, Huyett LM, Lee JB, O'Connor J, Benjamin E, Dumais B, Ly TT. Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment. Diabetes Technol Ther. 2022 Jan;24(1):18-25. doi: 10.1089/dia.2021.0140. Epub 2021 Sep 3.

  PMID: 34491825 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Trang Ly
• Organization: Insulet Corporation

tly@insulet.com

9786007628

Study Officials

• Jordan Pinsker, MD

  Sansum Diabetes Research Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, multi-center, prospective clinical study.

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: June 9, 2020
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)