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

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ClinicalTrials.gov Identifier: NCT06024928
Recruitment Status : Not yet recruiting
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Anas El Fathi, University of Virginia

Study Description
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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
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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
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 14, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024928


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

Locations
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United States, Virginia
University of Virginia Center for Diabetes Technology
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
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Principal Investigator: Anas El Fathi, PhD University of Virginia Center for Diabetes Technology
More Information
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Responsible Party: Anas El Fathi, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT06024928    
Other Study ID Numbers: 230316
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: August 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.

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