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

November 29, 2023 updated by: Anas El Fathi, University of Virginia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Center for Diabetes Technology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ralf M Nass, MD
        • Sub-Investigator:
          • Boris Kovatchev, PhD
        • Principal Investigator:
          • Anas El Fathi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 14, 2025

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data will be made available after the primary publications of the study.

IPD Sharing Access Criteria

The Data Sharing Agreements will be formulated by the study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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