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

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ClinicalTrials.gov Identifier: NCT04073576
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Christchurch Clinical Studies Trust Ltd

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.

Condition or disease Intervention/treatment Phase
Type1diabetes Device: AHCL Device: SAP+PLGM Not Applicable

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:

  1. Advanced Hybrid Closed Loop (AHCL - the new algorithm)
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : October 11, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: AHCL
Advanced Hybrid Closed Loop
Device: AHCL
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.

Active Comparator: SAP+PLGM
Sensor Augmented Pump with Predictive Low Glucose Monitoring
Device: SAP+PLGM
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 Measures :
  1. Performance of the AHCL system [ Time Frame: 4 weeks ]
    percentage of sensor glucose values between 3.9 - 10.0 mmol/L


Secondary Outcome Measures :
  1. Safety of the AHCL system [ Time Frame: 4 weeks ]
    percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test).
  2. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
  3. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
  4. Current use of SGLT-2 or GLP-1 medications.
  5. History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
  6. History of severe visual impairment, in the opinion of the Investigator.
  7. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073576


Locations
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New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, Canterbury, New Zealand, 8011
Contact: Jo Sanders    +6433729477    jo@ccst.co.nz   
Sponsors and Collaborators
Christchurch Clinical Studies Trust Ltd
Medtronic

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Responsible Party: Christchurch Clinical Studies Trust Ltd
ClinicalTrials.gov Identifier: NCT04073576     History of Changes
Other Study ID Numbers: CH-1803-AHCL
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs