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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Control-IQ use in Type 2 Diabetes under basal insulin injections


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated Insulin Delivery in the Basal Insulin Titration Phase<br>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<br>* 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.<br>* Other names: Tandem Diabetes Care;|
| No Intervention: Standard Care with Study Continuous Glucose Monitor<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated Insulin Delivery (AID), Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ), Basal Insulin Titration (BIT)