N/A
Completed N=50
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
Type 1 diabetes mellitus · Cognitive Change
Source: ClinicalTrials.gov NCT03674281 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Time of Blood Glucose in Range 70-180 mg/dL — 69.6; 79.6; 50.9; 69.2 percentage of time — p=0.002
Summary
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time of Blood Glucose in Range 70-180 mg/dL |
69.6; 79.6; 50.9; 69.2 | 0.002 sig |
| SECONDARY Ecological Momentary Assessments |
2.42; 2.21; 2.45; 2.3 | — |
| SECONDARY Sleep Patterns |
5.86; 5.71; 5.50; 4.38; 3.54; 3.62 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year, using insulin for at least 1 year and using an insulin pump for at least 6 months.
- Familiarity and use of a carbohydrate ratio for meal boluses by participants and families participating.
- Age 6-10 years old or 65 years or older
- Hemoglobin A1c 160/90 mm Hg).
- Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility).
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
Data sourced from ClinicalTrials.gov (NCT03674281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.