Clinical trial NCT06024928: Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes
Official title: Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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.
7. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
8. History of hypoglycemia unawareness.

Primary outcomes:
measure: System Testing survey
timeFrame: 14 days
measure: Percent Time in Range
timeFrame: 14 days
Secondary outcomes:
measure: Percent Time Below Range
timeFrame: 14 days
measure: Percent Time Above Range
timeFrame: 14 days
measure: Percent Time in Tighter Range
timeFrame: 14 days
measure: Percent Time Below Range (Hypoglycemia)
timeFrame: 14 days
measure: Percent Time Above Range (Hyperglycemia)
timeFrame: 14 days
measure: Mean glucose reading measured by Continuous Glucose Monitor (CGM)
timeFrame: 14 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia Center for Diabetes Technology
name: Anas El Fathi, PhD
role: PRINCIPAL_INVESTIGATOR
References: