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

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control-IQ use in Type 2 Diabetes under basal insulin injections
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Automated Insulin Delivery (AID), Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ), Basal Insulin Titration (BIT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18.0 years old at time of consent. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year. HbA1c ≥ 7.5%. Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec) Willingness to discontinue a personal CGM during the duration of the study. Access to the internet and willingness to upload data during the study as needed. 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. 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: Treatment with meglitinides/sulfonylureas. 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). Currently being treated for a seizure disorder. 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. Currently pregnant or intent to become pregnant during the trial. Currently breastfeeding.

Sites / Locations

  • University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Automated Insulin Delivery in the Basal Insulin Titration Phase

Standard Care with Study Continuous Glucose Monitor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2023
Last Updated
September 5, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT06024928
Brief Title
Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes
Acronym
AID-BIT
Official Title
Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Automated Insulin Delivery (AID), Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ), Basal Insulin Titration (BIT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automated Insulin Delivery in the Basal Insulin Titration Phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care with Study Continuous Glucose Monitor
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Control-IQ use in Type 2 Diabetes under basal insulin injections
Other Intervention Name(s)
Tandem Diabetes Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
System Testing survey
Description
Receiving feedback from the participants regarding system functionality.
Time Frame
14 days
Title
Percent Time in Range
Description
The percent of time spent within glycemic range of 70 to 180 mg/mL.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Percent Time Below Range
Description
The percent of time spent below 70 mg/mL.
Time Frame
14 days
Title
Percent Time Above Range
Description
The percent of time spent above 180 mg/mL.
Time Frame
14 days
Title
Percent Time in Tighter Range
Description
The percent of time spent within glycemic range of 70 to 140 mg/mL.
Time Frame
14 days
Title
Percent Time Below Range (Hypoglycemia)
Description
The percent of time spent below 54 mg/mL.
Time Frame
14 days
Title
Percent Time Above Range (Hyperglycemia)
Description
The percent of time spent above 250 mg/mL.
Time Frame
14 days
Title
Mean glucose reading measured by Continuous Glucose Monitor (CGM)
Description
Glucose variability measured by coefficient of variation.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18.0 years old at time of consent. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year. HbA1c ≥ 7.5%. Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec) Willingness to discontinue a personal CGM during the duration of the study. Access to the internet and willingness to upload data during the study as needed. 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. 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: Treatment with meglitinides/sulfonylureas. 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). Currently being treated for a seizure disorder. 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. Currently pregnant or intent to become pregnant during the trial. Currently breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf M Nass, MD
Phone
434-982-0868
Email
rmn9a@uvahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas El Fathi, PhD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf M Nass, MD
Phone
434-982-0868
Email
rmn9a@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Lianna H Smith
Phone
434-466-4856
Email
lhs7px@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Ralf M Nass, MD
First Name & Middle Initial & Last Name & Degree
Boris Kovatchev, PhD
First Name & Middle Initial & Last Name & Degree
Anas El Fathi, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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