Type 1 DiabetesNCT01712594
Safety and Effectiveness Study of a Closed Loop System Maintaining Patients' Glucose Levels During an Overnight Period
A study testing Closed Loop Procedure (Medtronic) in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 1 site in United Kingdom.
Trial summary
Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor glucose readings when making their insulin dosage decisions. Designing a computerized system that mimics the way insulin is produced naturally in a person who does not have type 1 diabetes holds many challenges; all of which… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Closed Loop Procedure (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Dec 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
- Weight is between 50 and 120 kg
- Subject has used a Medtronic insulin pump for at least the previous 6 months
- Subject has an glycated hemoglobin (A1C) value ≤ 9.0% demonstrated at the time of enrollment
- Subject uses a rapid-acting analogue insulin in his/her pump
Who cannot join
- Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
- Subject has an exclusionary cardiac disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of a Closed Loop Insulin Delivery System (Aka AAGC) With an Artificially Induced Calibration Error During the Overnight Period
Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor glucose readings when making their insulin dosage decisions. Designing a computerized system that mimics the way insulin is produced naturally in a person who does not have type 1 diabetes holds many challenges; all of which cannot be addressed in just one study. The purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system designed to automatically infuse the correct insulin dose during the hours that the patient is sleeping.
The system consists of an insulin pump that provides insulin to the patient through an infusion set. A sensor inserted just under the patient's skin measures glucose levels and a transmitter sends this information to the pump. To enable the sensor to register the glucose information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times a day. In the commercially released system, the physician would recommend the continuous background (basal) insulin rates and the patient would be required to make decisions regarding extra insulin (bolus) for meals or as a response to high glucose levels.
Read more
In the Closed Loop System, a mobile control system is added to these devices. This consists of an Android phone, a closed loop algorithm and a translator. This system is designed to translate the sensor information and direct the pump to provide the required dosage of insulin automatically without requiring input from the patient.
Reliable calibration has proved challenging, and so it is important that the system function safely, even when calibration is inaccurate. In this study, a calibration error will be introduced under very controlled circumstances. This testing will identify if the system can maintain acceptable overnight glucose levels, regardless of whether or not calibration is ideal.
- Conditions
- Type 1 Diabetes
- Being tested
- Closed Loop Procedure (Medtronic)
- Keywords
- United Kingdom Overnight closed loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Loop Procedure (Medtronic)Device
Also called AAGC
The procedure A is the device running under normal conditions, procedure B will incorporate an induced calibration error.
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop Procedure AB | Active comparator | Closed loop procedure with normal calibration first followed by closed loop procedure B with calibration error induced. Receives: Device: Closed Loop Procedure (Medtronic) |
| Closed loop Procedure BA | Active comparator | Closed loop procedure with an induced calibration error first followed by closed loop procedure with normal calibration. Receives: Device: Closed Loop Procedure (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time spent in the target range defined as 3.8-8.8 mmol/l (70 to 160 mg/dL) YSI glucose during in-clinic overnight visits
Subjects will arrive at the research facility between 17:00 and 18:00. Plasma glucose will be measured and they will have their evening meal of no more than 80 g of carbohydrate. They will bolus for this meal using their usual Bolus Wizard (Medtronic) settings. After the meal, an IV catheter will be inserted for the collection of venous blood samples. The Mobile Control System will be connected and closed-loop control will be started approximately 4 hours after dinner. The subject will remain under closed-loop control overnight (approximately 11 p.m.-6 a.m.). During one of the Closed Loop nights the system will be challenged by a calibration error of 30%. At approximately 7 am (before breakfast), the Mobile Control System will be turned off and the patient will be provided with a breakfast (approximately 40-70 gm of carbohydrate) and will take a bolus according to the Bolus Wizard. The patient will return to their usual pump treatment with the MiniMed Paradigm Veo System.
Measured: Two in-patient nights
Secondary outcomes (2)
Glucose Area under the curve (AUC) below 3.8 mmol/l (70 mg/dL ) YSI glucose obtained during in-clinic overnight visits
Blood glucose samples will be obtained from the line approximately every 30 minutes, or every 5-15 minutes at treating physician's discretion, if either the sensor or a previous glucose reading is < 81mg/dL or > 360mg/dL (< 3.5 mmol/l or > 20 mmol/l). Plasma samples will be analyzed using a YSI 2300 Glucose and Lactate Analyzer between 18:00 and 6:00.
Measured: Two overnight closed loop sessions
Glucose AUC above 8.8mmol/l (160 mg/dL) YSI glucose obtained during in-clinic overnight visits
Blood glucose samples will be obtained from the line approximately every 30 minutes, or every 5-15 minutes at treating physician's discretion, if either the sensor or a previous glucose reading is < 81mg/dL or > 360mg/dL (< 3.5 mmol/l or > 20 mmol/l). Plasma samples will be analyzed using a YSI 2300 Glucose and Lactate Analyzer (YSI, Inc., OH, USA) between 18:00 and 6:00.
Measured: Two overnight closed loop sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712594
- Sponsor's protocol ID
- CEP223
- Status last verified
- May 2017
- First submitted
- 19 Oct 2012
- Last updated
- 12 May 2017
- 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of a Closed Loop Insulin Delivery System (Aka AAGC) With an Artificially Induced Calibration Error During the Overnight Period
- ClinicalTrials.gov ID
- NCT01712594
- Acronym / sponsor ID
- CEP223
- Conditions
- Type 1 Diabetes
- Keywords
- United Kingdom Overnight closed loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Oct 2012 (estimated)
- 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.
Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor glucose readings when making their insulin dosage decisions. Designing a computerized system that mimics the way insulin is produced naturally in a person who does not have type 1 diabetes holds many challenges; all of which cannot be addressed in just one study. The purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system designed to automatically infuse the correct insulin dose during the hours that the patient is sleeping.
The system consists of an insulin pump that provides insulin to the patient through an infusion set. A sensor inserted just under the patient's skin measures glucose levels and a transmitter sends this information to the pump. To enable the sensor to register the glucose information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times a day. In the commercially released system, the physician would recommend the continuous background (basal) insulin rates and the patient would be required to make decisions regarding extra insulin (bolus) for meals or as a response to high glucose levels.
In the Closed Loop System, a mobile control system is added to these devices. This consists of an Android phone, a closed loop algorithm and a translator. This system is designed to translate the sensor information and direct the pump to provide the required dosage of insulin automatically without requiring input from the patient.
Reliable calibration has proved challenging, and so it is important that the system function safely, even when calibration is inaccurate. In this study, a calibration error will be introduced under very controlled circumstances. This testing will identify if the system can maintain acceptable overnight glucose levels, regardless of whether or not calibration is ideal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Loop Procedure AB | Active comparator | Device: Closed Loop Procedure (Medtronic)Closed loop procedure with normal calibration first followed by closed loop procedure B with calibration error induced. |
| Closed loop Procedure BA | Active comparator | Device: Closed Loop Procedure (Medtronic)Closed loop procedure with an induced calibration error first followed by closed loop procedure with normal calibration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
- Weight is between 50 and 120 kg
- Subject has used a Medtronic insulin pump for at least the previous 6 months
- Subject has an glycated hemoglobin (A1C) value ≤ 9.0% demonstrated at the time of enrollment
- Subject uses a rapid-acting analogue insulin in his/her pump
Key exclusion criteria (3 listed)
- Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
- Subject has an exclusionary cardiac disorder
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 |
|---|---|---|
| Closed Loop Procedure (Medtronic)Also: AAGCThe procedure A is the device running under normal conditions, procedure B will incorporate an induced calibration error. | Device | Closed Loop Procedure AB, Closed loop Procedure BA |
Primary outcome
Amount of time spent in the target range defined as 3.8-8.8 mmol/l (70 to 160 mg/dL) YSI glucose during in-clinic overnight visits
Time frame: Two in-patient nights
Subjects will arrive at the research facility between 17:00 and 18:00. Plasma glucose will be measured and they will have their evening meal of no more than 80 g of carbohydrate. They will bolus for this meal using their usual Bolus Wizard (Medtronic) settings. After the meal, an IV catheter will be inserted for the collection of venous blood samples. The Mobile Control System will be connected and closed-loop control will be started approximately 4 hours after dinner. The subject will remain under closed-loop control overnight (approximately 11 p.m.-6 a.m.). During one of the Closed Loop nights the system will be challenged by a calibration error of 30%. At approximately 7 am (before breakfast), the Mobile Control System will be turned off and the patient will be provided with a breakfast (approximately 40-70 gm of carbohydrate) and will take a bolus according to the Bolus Wizard. The patient will return to their usual pump treatment with the MiniMed Paradigm Veo System.
2 secondary outcomes
Glucose Area under the curve (AUC) below 3.8 mmol/l (70 mg/dL ) YSI glucose obtained during in-clinic overnight visits
Time frame: Two overnight closed loop sessions
Glucose AUC above 8.8mmol/l (160 mg/dL) YSI glucose obtained during in-clinic overnight visits
Time frame: Two overnight closed loop sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop Procedure (Medtronic) in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 1 site in United Kingdom.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 12 May 2017. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of time spent in the target range defined as 3.8-8.8 mmol/l (70 to 160 mg/dL) YSI glucose during in-clinic overnight visits (time frame: Two in-patient nights). 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 12 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.