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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK133148 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated Insulin Delivery in the Basal Insulin Titration Phase | Experimental | 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. |
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| Standard Care with Study Continuous Glucose Monitor | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control-IQ use in Type 2 Diabetes under basal insulin injections | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Currently using an approved intermediate (e.g., insulin 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:
Currently pregnant or intent to become pregnant during the trial.
Currently breastfeeding.
Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
History of hypoglycemia unawareness.
On a non-stable dose of non-insulin glucose-lowering agent prior to the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals) as defined by study physician.
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Nass, MD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Data will be made available after the primary publications of the study.
The Data Sharing Agreements will be formulated by the study team.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2025 | Jan 15, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| 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 |
| D004700 | Endocrine System Diseases |