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

• ClinicalTrials.gov Identifier: NCT06024928
• Recruitment Status: Recruiting
• First Posted: September 6, 2023
• Last Update Posted: December 6, 2023
• Sponsor: University of Virginia
• Information provided by (Responsible Party): Anas El Fathi, University of Virginia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Device: Control-IQ use in Type 2 Diabetes under basal insulin injections	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study is a randomized controlled parallel design trial where participants will be randomized 1:1 to either a control group or an experimental group.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
• Actual Study Start Date: November 1, 2023
• Estimated Primary Completion Date: January 1, 2025
• Estimated Study Completion Date: January 14, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Automated Insulin Delivery in the Basal Insulin Titration Phase; Participants will use Automated Insulin Delivery (AID) for 10 days in the Basal Insulin Titration (BIT) Phase. This group will then return to their original home therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP) with a blinded CGM. The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.	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.; Other Name: Tandem Diabetes Care
No Intervention: Standard Care with Study Continuous Glucose Monitor; Participants will use a study Continuous Glucose Monitor (CGM) along with their original home therapy and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. This group will then transition into a 10-day Maintenance Phase (MP) using a blinded CGM, where the basal dose will be maintained.

Outcome Measures

Primary Outcome Measures :

1. System Testing survey [ Time Frame: 14 days ]
   Receiving feedback from the participants regarding system functionality.
2. Percent Time in Range [ Time Frame: 14 days ]
   The percent of time spent within glycemic range of 70 to 180 mg/mL.

Secondary Outcome Measures :

1. Percent Time Below Range [ Time Frame: 14 days ]
   The percent of time spent below 70 mg/mL.
2. Percent Time Above Range [ Time Frame: 14 days ]
   The percent of time spent above 180 mg/mL.
3. Percent Time in Tighter Range [ Time Frame: 14 days ]
   The percent of time spent within glycemic range of 70 to 140 mg/mL.
4. Percent Time Below Range (Hypoglycemia) [ Time Frame: 14 days ]
   The percent of time spent below 54 mg/mL.
5. Percent Time Above Range (Hyperglycemia) [ Time Frame: 14 days ]
   The percent of time spent above 250 mg/mL.
6. Mean glucose reading measured by Continuous Glucose Monitor (CGM) [ Time Frame: 14 days ]
   Glucose variability measured by coefficient of variation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Ralf M Nass, MD; 434-982-0868; rmn9a@uvahealth.org

Locations

United States, Virginia

University of Virginia Center for Diabetes Technology; Recruiting

Charlottesville, Virginia, United States, 22903

Contact: Ralf M Nass, MD 434-982-0868 rmn9a@uvahealth.org

Contact: Lianna H Smith 434-466-4856 lhs7px@uvahealth.org

Sub-Investigator: Ralf M Nass, MD

Sub-Investigator: Boris Kovatchev, PhD

Principal Investigator: Anas El Fathi, PhD

Sponsors and Collaborators

University of Virginia

Investigators

• Principal Investigator: Anas El Fathi, PhD; University of Virginia Center for Diabetes Technology

More Information

• Responsible Party: Anas El Fathi, Principal Investigator, University of Virginia
• ClinicalTrials.gov Identifier: NCT06024928
• Other Study ID Numbers: 230316
• First Posted: September 6, 2023
• Last Update Posted: December 6, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Data will be made available after the primary publications of the study.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Anas El Fathi, University of Virginia:

Automated Insulin Delivery (AID); Continuous Glucose Monitor (CGM); Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ); Basal Insulin Titration (BIT)

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs