Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Control-IQ Technology 2.0 Feasibility Study in Adult and Adolescent Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05014789
• Other study ID #: G210146
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.

Description:

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Adult and adolescent male and female subjects >age 14 years

• Clinical diagnosis of Type 1 diabetes for at least one year

• Experienced Control-IQ technology user for =3 months.

• Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening.

• Not pregnant or planning a pregnancy during the time period of the study

• Using only Humalog U-100 or Novolog U-100 insulin

• ICR and ISF optimized per investigator judgement

• CGM time in range (70-180 mg/dL) at least 50% on Control-IQ technology

• Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)

• Willing to:

1. Share Dexcom G6 CGM data with study staff and Tandem

2. Share t:connect data with Tandem

3. Eat meals with known carbohydrate amounts

4. Take meal boluses as directed (use of different options as scheduled and instructed)

5. Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia

6. Keep food and exercise diary

7. Set accurate sleep schedule on pump

8. Exercise while using exercise activity in Control-IQ technology at least twice weekly

9. Complete questionnaires before and after using investigational device

10. Sign an informed consent form

• Willingness to use the Dexcom G6 app on their personal phone throughout the study, and share real time CGM information with a local contact and study staff

• Availability of a local contact who has access to the study participant, knows their whereabouts, and agrees to be promptly available if contacted by study staff. If the subject lives alone, the local contact must live within 30 minutes and have access to the subject overnight.

Exclusion Criteria:

• Diabetic ketoacidosis (DKA) in the past 6 months

• Severe hypoglycemia (needing assistance) in the past 6 months

• Inpatient psychiatric treatment in the past 6 months

• History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or is unwilling to agree to abstain from illicit drugs throughout the study

• History of heart, lung or kidney disease determined by the investigator to interfere with the study

• Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with the study

• Use of long-acting insulin or any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than metformin

• Use of Afrezza during the study period

• Febrile illness within 3 days of the start of the study

• Subject is pregnant or lactating or intending to become pregnant before or during participation in this study

• For subjects >50 years old or with diabetes duration >20 years who will be exercising as part of the 48 hour study, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)

• Significant chronic kidney disease (eGFR < 60) or hemodialysis

• Significant liver disease

• History of adrenal insufficiency

• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Control-IQ technology 2.0
All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant Hypoglycemia	CGM percent time <54 mg/dL during each week of feature use, as well as during baseline and run-in periods	8 weeks
Primary	Severe hypoglycemia (needing assistance)	Number of severe hypoglycemic events (per protocol) during each week of feature use, as well as during baseline and run-in periods	8 weeks
Primary	Diabetic Ketoacidosis	Number of participants with Diabetic Ketoacidosis (per protocol) during each week of feature use, as well as during baseline and run-in periods	8 weeks
Primary	Serious Adverse Events	Number of Serious Adverse Events during each week of feature use, as well as during baseline and run-in periods	8 weeks
Secondary	Percent of time <70 mg/dL	CGM percent time <70 mg/dL during each week of feature use, as well as during baseline and run-in periods	8 weeks
Secondary	Percent of time > 250 mg/dL	CGM percent time > 250 mg/dL during each week of feature use, as well as during baseline and run-in periods	8 weeks
Secondary	Percent of time 70-180 mg/dL	CGM percent time in range 70-180 mg/dL during each week of feature use, as well as during baseline and run-in periods	8 weeks
Secondary	Percent of time 70-140 mg/dL	CGM percent time in range 70-140 mg/dL, during each week of feature use, as well as during baseline and run-in periods	8 weeks
Secondary	Postprandial glycemic peak mg/dL	Peak CGM glucose after each meal, during each week of feature use, as well as during baseline and run-in periods	8 weeks
Secondary	CGM Metrics by time of day	Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only, and Nighttime only.	8 weeks