N/A
Completed N=101
A Study of t:Slim X2 With Control-IQ Technology
Source: ClinicalTrials.gov NCT03844789 ↗Enrolled (actual)
101
Serious AEs
0.5%
Results posted
Apr 2023
Primary outcomePrimary: Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period — 67; 55 Percentage of Time
Summary
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period |
67; 55 | — |
| SECONDARY CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period |
31; 43 | — |
| SECONDARY CGM-Measured Mean Glucose Over 16 Week Trial Period |
162; 179 | — |
| SECONDARY Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period |
7.0; 7.6 | — |
| SECONDARY CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period |
1.57; 1.80 | — |
| SECONDARY CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period |
0.23; 0.29 | — |
| SECONDARY CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period |
7.8; 18.4 | — |
| SECONDARY Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period |
38; 39 | — |
| SECONDARY CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period |
33; 34 | — |
| SECONDARY CGM-measured Mean Glucose Over 12 Week Trial Extension Period |
165; 167 | — |
| SECONDARY Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period |
7.2; 7.3 | — |
| SECONDARY CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period |
1.50; 1.34 | — |
| SECONDARY CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period |
0.25; 0.25 | — |
| SECONDARY CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period |
9.0; 10.1 | — |
| SECONDARY Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period |
38; 38 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥ 6 and ≤ 13 years old
- Weight ≥25 kg and ≤140 kg
- 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. 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.
- Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
- Willingness to suspend use of any personal closed loop system that they use at home for the duration of the clinical trial once the study CGM is in use
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using to t:slim X2. This includes:
- Participants randomized to Control IQ
- Participants on the SAP group on MDI treatment that will be provided a Tandem pump to switch to CSII
- Participates that are already in Continuous Subcutaneous Insulin Infusion (CSII) randomized to SAP during the extension phase when transition to Control IQ
- Total daily insulin dose (TDD) at least 10 U/day
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
Exclusion Criteria
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including glucagon-like peptide [GLP-1] agonists, Symlin, dipeptidyl peptidase 4 [DPP-4] inhibitors, sodium-glucose cotransporter-2 (SGLT2) 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 (specified on the study procedure manual)
- 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 (NCT03844789). 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.