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

Type 1 Diabetes Clinical Trial

Official title:

Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320069
• Other study ID #: G200018
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: September 29, 2020

Study information

• Verified date: November 2023
• Source: Insulet Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study schedule consists of two outpatient phases: 1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by; 2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2) Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study. Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator. After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age at time of consent/assent 2-70 years

2. Subjects aged < 18 years must be living with parent/legal guardian

3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment

4. Must be a current Omnipod user, or have used an Omnipod in the past

5. Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol

6. Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra

7. Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality

8. 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

9. 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

10. Willing to wear the system continuously throughout the study

11. For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C <10%

12. 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)

13. Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)

14. 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.

15. 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.

Exclusion Criteria:

1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk

2. History of severe hypoglycemia in the past 6 months

3. History of DKA in the past 6 months, unrelated to an intercurrent illness or infusion set failure

4. Plans to receive blood transfusion over the course of the study

5. Currently diagnosed with anorexia nervosa or bulimia

6. Acute or chronic kidney disease or currently on hemodialysis

7. History of adrenal insufficiency

8. Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study

9. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement

10. Plans to use insulin other than U-100 insulin intended for use in the study device during the study

11. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)

12. 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

13. Clinical signs of hypothyroidism and hyperthyroidism

14. 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)

15. 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.

16. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Omnipod Horizon™ Automated Glucose Control System
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode

Locations

Country	Name	City	State
United States	Atlanta Diabetes	Atlanta	Georgia
United States	University of Virginia	Charlottesville	Virginia
United States	University of Colorado Denver	Denver	Colorado
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Insulet Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Mean Glucose	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary	Percentage of Time <54 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary	Percentage of Time = 250 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary	Percentage of Time = 300 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary	Percentage of Time in Range 70-180 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary	Mean Glucose	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time <54 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time <70 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time >180 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time = 250 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time = 300 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time in Range 70-180 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Percentage of Time in Range 70-140 mg/dL	Glucose metric from continuous glucose monitoring system (CGM)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Standard Deviation	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Secondary	Coefficient of Variation	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)	Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall