Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

NCT03195140 | Completed Results FDA Device

• 1 other identifier: G170105
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 4

Brief Summary

A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth \> 6 years old with type 1 diabetes (T1D).

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus; Diabetes; Sensor Augmented Pump; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia < 70 mg/dL

  Percentage of time CGM \<70 mg/dL

  3 weeks

Secondary Outcomes (10)

• Hypoglycemia <60 mg/dL

  3 weeks

• Hypoglycemia <50 mg/dL

  3 weeks

• Hypoglycemia AOC <70 mg/dL

  3 weeks

• Low Blood Glucose Index (LBGI)

  3 weeks

• Hypoglycemic Events Per Week

  3 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump.

Device: Predictive Low Glucose Suspend

Control Arm

NO INTERVENTION

The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.

Interventions

Predictive Low Glucose Suspend DEVICE

Application of Predictive Low Glucose Suspend

Intervention Arm

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)
• \. Age ≥6.0 years old
• \. 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
• \. 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.
• \. Investigator has confidence that the participant can successfully use all study devices and is capable of adhering to the protocol

You may not qualify if:

• \. Anticipated need to use acetaminophen during study participation
• \. 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
• \. 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
• \. 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.

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

Location

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8.

  PMID: 30089663 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

1 participant did not have baseline data available, so outcome measures report on 102 of the 103 participants.

Results Point of Contact

• Title: Jordan Pinsker, MD
• Organization: Tandem Diabetes Care, Inc

clinicalaffairs@tandemdiabetes.com

858-366-6900

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Vance Swanson

  Tandem Diabetes Care, Inc.

  STUDY CHAIR

• John Lum, MS

  JCHR

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized, crossover design, consisting of two 3-week periods, with the PLGS System used during one period and SAP therapy used during the other period. The crossover trial will be preceded by a run-in phase in which participants may receive training using the study devices. For 10 adult participants, a PLGS Pilot Period will proceed to the crossover trial to ensure safety and usability objectives are met prior to the start of the crossover trial.

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 22, 2017
• Study Start: August 11, 2017
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)