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Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Predictive Low Glucose Suspend

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Diabetes, Sensor Augmented Pump, Hypoglycemia

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University
William Sansum Diabetes Center
Barbara Davis Center
Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sensor Glucose Values

Percentage of sensor glucose values <70 mg/dL

Secondary Outcome Measures

Hypoglycemia <60 mg/dL

Percentage of values <60 mg/dL

Hypoglycemia <50 mg/dL

Percentage of values <50 mg/dL

Hypoglycemia AUC <70 mg/dL

Area Under Curve (AUC) <70 mg/dL

Hypoglycemia index

Low blood glucose index

Hypoglycemic events

Frequency of CGM-measured hypoglycemic events

Glucose Control

Mean glucose; Percentage of values 70 to 180 mg/dL

Hyperglycemia >250 mg/dL

Percentage of values >250 mg/dL

Hyperglycemia >180 mg/dL

Percentage of values >180 mg/dL

Hyperglycemia AUC >180 mg/dL

AUC glucose >180 mg/dL

Hyperglycemia index

High blood glucose index

Full Information

NCT ID

NCT03195140

First Posted

June 14, 2017

Last Updated

February 7, 2018

Sponsor

Tandem Diabetes Care, Inc.

Collaborators

Jaeb Center for Health Research

1. Study Identification

Unique Protocol Identification Number

NCT03195140

Brief Title

Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

Official Title

Tandem PLGS Pivotal Trial: A Randomized Clinical Trial to Assess the Efficacy of Predictive Low Glucose Suspend Versus Sensor-augmented Pump Therapy in the Management of Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

August 11, 2017 (Actual)

Primary Completion Date

February 6, 2018 (Actual)

Study Completion Date

February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tandem Diabetes Care, Inc.

Collaborators

Jaeb Center for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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).

Detailed Description

Screening and Enrollment Informed consent will be signed and eligibility will be assessed History and physical examination HbA1c measurement Urine or serum pregnancy test (if applicable) Evaluation of Continuous Glucose Monitoring (CGM) and pump experience CGM and (Sensor Augmented Pump) SAP Training Period at Home All eligible participants will be assessed based on their CGM and pump experience to determine if the CGM Training Period, the SAP Training Period, or both are required. CGM Training Period (10-14 days): Participants currently using a CGM may skip the CGM Training Period per investigator discretion, generally requiring that CGM has been used on at least 85% of days during the prior 4 weeks. SAP Training Period (14-28 days): Participants currently using a Tandem pump concomitantly with a Dexcom CGM may skip both the CGM Training and the SAP Training periods per investigator discretion. i. The Tandem SAP pump will be used during the SAP Training Period and pump training will be customized based on prior pump experience PLGS Pilot Phase Prior to the initiation of the crossover trial, 10 adult participants will use the Tandem PLGS pump and CGM system in a 10-day Pilot Period. Data will be evaluated for system usability and predetermined safety metrics before participants ≥12 years old can be randomized into the crossover trial. Randomized Crossover Trial The crossover trial will begin after the data from the Pilot Period have been reviewed. Enrollment of participants 6 to 11 years old will be deferred until data from 100 post-randomization PLGS participant-days have been evaluated from participants 12 to 17 years old and the same predetermined safety metrics used to evaluate the Pilot Period have been satisfied. At the Crossover Trial initiation visit, the following will be done: The clinician will confirm the participant's willingness to participate in the crossover trial The participant's HbA1c level will be measured Random assignment to Group A or Group B Group A: intervention period first (PLGS), control period second (SAP) Group B: control period first (SAP), intervention period second (PLGS) During each of the two 3-week periods, a phone, email, or text contact will occur at 2 and 14 days, and a clinic visit at 7 and 21 days. HbA1c will be measured at the end of each period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Diabetes, Sensor Augmented Pump, Hypoglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Predictive Low Glucose Suspend

Intervention Description

Application of Predictive Low Glucose Suspend

Primary Outcome Measure Information:

Title

Sensor Glucose Values

Description

Percentage of sensor glucose values <70 mg/dL

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Hypoglycemia <60 mg/dL

Description

Percentage of values <60 mg/dL

Time Frame

3 weeks

Title

Hypoglycemia <50 mg/dL

Description

Percentage of values <50 mg/dL

Time Frame

3 weeks

Title

Hypoglycemia AUC <70 mg/dL

Description

Area Under Curve (AUC) <70 mg/dL

Time Frame

3 weeks

Title

Hypoglycemia index

Description

Low blood glucose index

Time Frame

3 weeks

Title

Hypoglycemic events

Description

Frequency of CGM-measured hypoglycemic events

Time Frame

3 weeks

Title

Glucose Control

Description

Mean glucose; Percentage of values 70 to 180 mg/dL

Time Frame

3 weeks

Title

Hyperglycemia >250 mg/dL

Description

Percentage of values >250 mg/dL

Time Frame

3 weeks

Title

Hyperglycemia >180 mg/dL

Description

Percentage of values >180 mg/dL

Time Frame

3 weeks

Title

Hyperglycemia AUC >180 mg/dL

Description

AUC glucose >180 mg/dL

Time Frame

3 weeks

Title

Hyperglycemia index

Description

High blood glucose index

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Buckingham, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vance Swanson

Organizational Affiliation

Tandem Diabetes Care, Inc.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

John Lum, MS

Organizational Affiliation

JCHR

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

William Sansum Diabetes Center

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Barbara Davis Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30089663

Citation

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.

Results Reference

derived

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Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

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