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Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.

Primary Purpose

Type1diabetes

Status

Unknown status

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

AHCL

SAP+PLGM

About this trial

This is an interventional treatment trial for Type1diabetes

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 7 - 80 years inclusive.
Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
On insulin pump therapy for at least 6 months prior to study Day 1.
Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
Willing and able to adhere to the study protocol.
Access to the internet and a computer system that meets requirements for uploading the study pump.

Exclusion Criteria:

Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test).
Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
Current use of SGLT-2 or GLP-1 medications.
History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
History of severe visual impairment, in the opinion of the Investigator.
If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Sites / Locations

Christchurch Clinical Studies TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AHCL

SAP+PLGM

Arm Description

Advanced Hybrid Closed Loop

Sensor Augmented Pump with Predictive Low Glucose Monitoring

Outcomes

Primary Outcome Measures

Performance of the AHCL system

percentage of sensor glucose values between 3.9 - 10.0 mmol/L

Secondary Outcome Measures

Safety of the AHCL system

percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L

Full Information

NCT ID

NCT04073576

First Posted

August 27, 2019

Last Updated

August 27, 2019

Sponsor

Christchurch Clinical Studies Trust Ltd

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT04073576

Brief Title

Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.

Official Title

Randomized Cross Over Trial of the MiniMed™ 670G 4.0 Insulin Pump, Comparing Advanced Hybrid Closed Loop Mode With Sensor Augmented Pump Therapy in Type 1 Diabetes.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 20, 2019 (Actual)

Primary Completion Date

October 11, 2019 (Anticipated)

Study Completion Date

October 11, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Christchurch Clinical Studies Trust Ltd

Collaborators

Medtronic

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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a study of the Minimed 670G 4.0 insulin pump, assessing the efficacy of the Advanced Hybrid Closed Loop (AHCL) algorithm in controlling blood glucose levels in Type 1 Diabetes.

Detailed Description

Insulin delivery systems are an increasingly popular treatment option for Type I Diabetes (T1D). Delivery systems consist of an insulin pump, a glucose sensor with a transmitter attached, and a maths program (algorithm) built into the pump. The algorithm uses sensor glucose levels to decide how much insulin should be delivered by the pump. This study aims to see how well a new algorithm controls blood glucose levels in T1D. The study uses the MiniMed 670G 4.0 insulin pump and compares two different algorithms: Advanced Hybrid Closed Loop (AHCL - the new algorithm) Sensor augmented pump therapy with predictive low-glucose management (SAP with PLGM). Approximately 60 participants with T1D, aged 7 - 80 years, will take part in the study. Every participant will receive the following two treatment algorithms in random order, with a two-week washout between treatments: MiniMed 670G 4.0 insulin pump in AHCL mode for 4 weeks. MiniMed 670G 4.0 insulin pump in SAP + PLGM mode for 4 weeks. During the study insulin pump data will be uploaded and changes in health will be monitored. In addition, participants will complete 3-day food diaries and a number of questionnaires. Participants at the Dunedin site will also be asked to complete home sleep studies during the trial (optional). The results of the study will be used to further develop insulin delivery systems. It is hoped this may improve treatment for people with diabetes.

6. Conditions and Keywords

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

Type1diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AHCL

Arm Type

Experimental

Arm Description

Advanced Hybrid Closed Loop

Arm Title

SAP+PLGM

Arm Type

Active Comparator

Arm Description

Sensor Augmented Pump with Predictive Low Glucose Monitoring

Intervention Type

Device

Intervention Name(s)

AHCL

Intervention Description

Closed loop algorithm contained in the MiniMed™ 670G 4.0 pump to be used in the study; includes a modified proportional integrative derivative (PID) model, with insulin feedback, an auto correction bolus feature and additional safety features.

Intervention Type

Device

Intervention Name(s)

SAP+PLGM

Intervention Description

Sensor Augmented Pump (SAP) Therapy Mode with Predictive Low Glucose Management (PLGM), contained in the the MiniMed™ 670G 4.0 pump to be used in the study.

Primary Outcome Measure Information:

Title

Performance of the AHCL system

Description

percentage of sensor glucose values between 3.9 - 10.0 mmol/L

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Safety of the AHCL system

Description

percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 7 - 80 years inclusive. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1. On insulin pump therapy for at least 6 months prior to study Day 1. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. Willing and able to adhere to the study protocol. Access to the internet and a computer system that meets requirements for uploading the study pump. Exclusion Criteria: Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test). Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted). Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit. Current use of SGLT-2 or GLP-1 medications. History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator. History of severe visual impairment, in the opinion of the Investigator. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Facility Information:

Facility Name

Christchurch Clinical Studies Trust

City

Christchurch

State/Province

Canterbury

ZIP/Postal Code

8011

Country

New Zealand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jo Sanders

Phone

+6433729477

jo@ccst.co.nz

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.

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