N/A
Completed N=103
Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03195140 ↗
Enrolled (actual)
103
Serious AEs
1.0%
Results posted
Dec 2023
Primary outcomePrimary: Hypoglycemia < 70 mg/dL — 3.6; 2.6; 3.2 percentage of time
Summary
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemia < 70 mg/dL |
3.6; 2.6; 3.2 | — |
| SECONDARY Hypoglycemia <60 mg/dL |
1.2; 0.9; 1.2 | — |
| SECONDARY Hypoglycemia <50 mg/dL |
0.3; 0.2; 0.3 | — |
| SECONDARY Hypoglycemia AOC <70 mg/dL |
0.31; 0.25; 0.30 | — |
| SECONDARY Low Blood Glucose Index (LBGI) |
0.9; 0.8; 0.9 | — |
| SECONDARY Hypoglycemic Events Per Week |
1.1; 0.8; 1.1 | — |
| SECONDARY Time in Range 70-180 mg/dL |
64; 65; 63 | — |
| SECONDARY Hyperglycemia >250 mg/dL |
7; 8; 8 | — |
| SECONDARY Hyperglycemia >180 mg/dL |
32; 32; 33 | — |
| SECONDARY Area Under Curve >180 mg/dL |
14.7; 15.8; 16.9 | — |
| SECONDARY High Blood Glucose Index (HBGI) |
6.7; 6.9; 7.4 | — |
Eligibility Criteria
Inclusion Criteria
- 1. Clinical diagnosis, based on investigator assessment, of T1D treated with insulin via an insulin pump or injections for at least 1 year, with no major change in the intensity of insulin therapy in the past 3 months (e.g. switching from injections to pump)
- 2. Age ≥6.0 years old
- 3. For participants <18 years old, living with one or more parents or guardians committed to participating in training and able to contact the participant in case of an emergency
- 4. For females, not currently known to be pregnant
- - 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 child-bearing potential. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- 5. Investigator has confidence that the participant can successfully use all study devices and is capable of adhering to the protocol
Exclusion Criteria
- 1. Anticipated need to use acetaminophen during study participation
- 2. Participation in another pharmaceutical or device trial at the time of enrollment or plan to participate in another study during the time period of participation in this study
- 3. Employed by, or having immediate family members employed by Tandem; 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
- 4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labelling
- - Individuals should not be enrolled with uncontrolled thyroid disease, renal failure (e.g., dialysis or estimated glomerular filtration (eGFR) <30), hemophilia or another major bleeding disorder, or unstable cardiovascular disease.
- - Laboratory testing and other work up needed to determine that an individual is a suitable candidate for the study should be performed as part of usual care.
Data sourced from ClinicalTrials.gov (NCT03195140). 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.