Type1diabetesNCT04073576
Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.
A study testing AHCL and SAP+PLGM in people with Type1diabetes, run by Christchurch Clinical Studies Trust Ltd at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 80 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- AHCL and SAP+PLGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNew Zealand
- Study dates
- 20 May 2019to 11 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Christchurch Clinical Studies Trust
Christchurch, Canterbury, 8011
Jo Sanders, +6433729477, jo@ccst.co.nz
About this study
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.
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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- AHCL, SAP+PLGM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHCLDevice
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.
SAP+PLGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AHCL | Experimental | Advanced Hybrid Closed Loop Receives: Device: AHCL |
| SAP+PLGM | Active comparator | Sensor Augmented Pump with Predictive Low Glucose Monitoring Receives: Device: SAP+PLGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the AHCL system
percentage of sensor glucose values between 3.9 - 10.0 mmol/L
Measured: 4 weeks
Secondary outcomes (1)
Safety of the AHCL system
percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start20 May 2019
- Primary completion11 Oct 2019 (estimated)
- Study completion11 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christchurch Clinical Studies Trust Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073576
- Sponsor's protocol ID
- CH-1803-AHCL
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04073576
- Acronym / sponsor ID
- CH-1803-AHCL
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Christchurch Clinical Studies Trust LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- 20 May 2019 (actual)
- Primary completion
- 11 Oct 2019 (estimated)
- Study completion
- 11 Oct 2019 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHCL | Experimental | Device: AHCLAdvanced Hybrid Closed Loop |
| SAP+PLGM | Active comparator | Device: SAP+PLGMSensor Augmented Pump with Predictive Low Glucose Monitoring |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHCLClosed 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. | Device | AHCL |
| SAP+PLGMSensor 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. | Device | SAP+PLGM |
Primary outcome
Performance of the AHCL system
Time frame: 4 weeks
percentage of sensor glucose values between 3.9 - 10.0 mmol/L
1 secondary outcome
Safety of the AHCL system
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHCL and SAP+PLGM in people with Type1diabetes, run by Christchurch Clinical Studies Trust Ltd at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the AHCL system (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.