Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— AID-BIT  

Official title:

Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024928
• Other study ID #: 230316
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: January 14, 2025

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: Ralf M Nass, MD
• Phone: 434-982-0868
• Email: rmn9a[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration. Participants will be randomized to either the control group or the experimental group. If in the experimental group, the participant will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days. Researchers will compare the glycemic control of the experimental group to the control group.

Description:

The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study will be performed at the University of Virginia (UVA), with screening procedures taking place either virtually or at the Clinical Research Unit (CRU) at UVA. All participants will undergo a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM). Participants will be randomized (1:1) to either the Control (CTR) Group or the Experimental (EXP) Group. In the EXP Group, participants will use an Automated Insulin Device (AID) for 10 days in the Basal Insulin Titration (BIT) Phase then return to their original therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP). The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose. During the same 10 days, in the CTR group, participants will use an unblinded CGM and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. Both groups will then go into a 10-days maintenance period using a blinded CGM. Outcomes will be measured in the last 7 days of the BIT and Maintenance Phases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 14, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18.0 years old at time of consent.

2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.

3. HbA1c = 7.5%.

4. Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec)

5. Willingness to discontinue a personal CGM during the duration of the study.

6. Access to the internet and willingness to upload data during the study as needed.

7. 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.

8. Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, Glucagon-like peptide (GLP)-1 receptor agonists, pramlintide, Dipeptidyl peptidase (DPP)-4 inhibitors, sulfonylureas and nutraceuticals).

Exclusion Criteria:

1. Treatment with meglitinides/sulfonylureas.

2. Currently using an approved intermediate (e.g., insulin Neutral Protamine Hagedorn (NPH)) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).

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: a) Inpatient psychiatric treatment in the past 6 months, b) Presence of a known adrenal disorder, c) Uncontrolled thyroid disease.

5. Currently pregnant or intent to become pregnant during the trial.

6. Currently breastfeeding.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Control-IQ use in Type 2 Diabetes under basal insulin injections
Testing the safety and feasibility of using Automated Insulin Delivery (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Testing survey	Receiving feedback from the participants regarding system functionality.	14 days
Primary	Percent Time in Range	The percent of time spent within glycemic range of 70 to 180 mg/mL.	14 days
Secondary	Percent Time Below Range	The percent of time spent below 70 mg/mL.	14 days
Secondary	Percent Time Above Range	The percent of time spent above 180 mg/mL.	14 days
Secondary	Percent Time in Tighter Range	The percent of time spent within glycemic range of 70 to 140 mg/mL.	14 days
Secondary	Percent Time Below Range (Hypoglycemia)	The percent of time spent below 54 mg/mL.	14 days
Secondary	Percent Time Above Range (Hyperglycemia)	The percent of time spent above 250 mg/mL.	14 days
Secondary	Mean glucose reading measured by Continuous Glucose Monitor (CGM)	Glucose variability measured by coefficient of variation.	14 days