Type 1 DiabetesPhase 2PSO1NCT01736930
An Outpatient Pump Shutoff Pilot Feasibility and Safety Study
A Phase 2 study testing Pump suspension in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pump suspension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months
- Age >=18.0 years
- HbA1c <=8.0%
- Availability of internet access for periodic upload of study data
- Experience using the Medtronic pump and CGM and investigator is confident that subject will use CGM on a near-daily basis during the study
- Nocturnal hypoglycemia meeting the following criterion based on CGM download: during the most recent 15 nights with CGM glucose data (must be within the past 42 days), one or more nights with a sensor glucose value <=70 mg/dL.
Who cannot join
- Diabetic ketoacidosis in the past 3 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder (except for hypoglycemic seizure)
- Coronary artery disease or heart failure
- Cystic fibrosis
- Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
Show all 10Show fewer
- History of ongoing renal disease (other than microalbuminuria). Creatinine level to have been obtained within the last year if subject has diabetes of >10 years duration or is over 50 years of age. If creatinine is > 1.5 mg/dL, the subject is excluded.
- History of liver disease
- Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: inpatient psychiatric treatment in the past 6 months, uncontrolled adrenal disorder, and/or abuse of alcohol
- Pregnancy: A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Stanford University
Stanford, California, 94305
About this study
Official title: Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Safety Study
The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off.
This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include 2 clinical centers in the United States.
Read the detailed description
Patients who meet all eligibility criteria will use the study system overnight at home for about 5 nights to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Patients who successfully demonstrate their ability to use the system as described above will be eligible for the randomized trial phase. This phase consists of use of the full system as an outpatient for approximately 21 nights:
- Each night the blood glucose level will be checked with the study blood glucose (BG) meter and used to perform a calibration of the CGM. The calibration must occur no more than 90 minutes prior to activation of the system. NOTE: Patients will be instructed to calibrate the CGM per manufacturer guidelines.
- Then the system will be activated, linking the CGM and insulin pump to the computer at the bedside.
- A randomization schedule on the laptop will be used to determine whether the 'pump shut off' application will be active that night or not.
- Patients will be blinded as to whether the pump shut off is active when a session is initiated each night.
- There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL. When a CGM alarm occurs, the patient will be asked to measure the blood glucose with a BG meter, if he/she is aware of the alarm.
- The time period for outcome assessment each night will be from the time the system is activated until it is turned off in the morning.
- Pump shut off, when it occurs, will be for up to 2 hours. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
- Patients will be asked to check blood glucose with the study BG meter, blood ketones with the study ketone meter, and urine ketones with a ketone strip each morning prior to breakfast and enter the results on the study laptop. The patient will be instructed to contact the study physician if the blood glucose or ketone readings are out of an expected range. Patients will be contacted if these morning safety values are not reported as required or are out of range.
- Patients will be asked to record all overnight carbohydrate intake on the study laptop.
- Patients will be asked to perform periodic data uploads using the study laptop. Monitoring processes will ensure that the patient is contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or urine ketone values.
Upon completion of the study, patients as well as study clinicians will be asked to complete a questionnaire regarding use of the study system.
There will a follow-up visit after completion of 21 successful nights of study system use. A successful night of study system use is defined as use of the system for at least four hours. Phone contacts with the patients will be made once a week.
- Conditions
- Type 1 Diabetes
- Being tested
- Pump suspension
- Keywords
- Type 1 Diabetes, Hypoglycemia, Continuous Glucose Monitoring, Pump Suspension
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pump suspensionDevice
The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
| Study group | Role | What they receive |
|---|---|---|
| Predictive pump suspension algorithm | Active comparator | The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. Receives: Device: Pump suspension |
| Standard of Care | No intervention | The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Morning Blood Glucose (mg/dL)- Algorithm 1
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).
An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes.
Measured: 21 study nights
Mean Morning Blood Glucose (mg/dL)- Algorithm 2
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).
Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2.
Measured: 21 study nights
Mean Morning Blood Glucose (mg/dL)- Algorithm 3
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).
The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3.
Measured: 21 study nights
Percent Morning Blood Glucose >250 mg/dL - Algorithm 1
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
Measured: 21 days
Percent Morning Blood Glucose >250 mg/dL - Algorithm 2
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
Measured: 21 days
Percent Morning Blood Glucose >250 mg/dL - Algorithm 3
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
Measured: 21 days
Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.
Measured: 21 days
Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.
Measured: 21 days
Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.
Measured: 21 days
Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.
Measured: 21 days
Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.
Measured: 21 days
Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.
Measured: 21 days
Secondary outcomes (6)
Mean Sensor Glucose Overnight - Algorithm 1
Measured: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Mean Sensor Glucose Overnight - Algorithm 2
Measured: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Mean Sensor Glucose Overnight - Algorithm 3
Measured: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1
Measured: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2
Measured: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3
Measured: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce A Buckingham, MD, Study chair, Stanford UniversityRoy W Beck, MD, PhD, Principal investigator, Jaeb Center for Health ResearchJohn Lum, MS, Study director, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736930
- Sponsor's protocol ID
- PSO1
- Other IDs
- R01DK085591
- Acronym
- PSO1
- Status last verified
- Aug 2016
- First submitted
- 20 Nov 2012
- Last updated
- 30 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Buckingham BA, Cameron F, Calhoun P, Maahs DM, Wilson DM, Chase HP, Bequette BW, Lum J, Sibayan J, Beck RW, Kollman C. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-7. doi: 10.1089/dia.2013.0040. Epub 2013 Jul 24.
PubMed 23883408
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT01736930
- Acronym / sponsor ID
- PSO1 / PSO1
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Hypoglycemia, Continuous Glucose Monitoring, Pump Suspension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 14 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off.
This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include 2 clinical centers in the United States.
Detailed description
Patients who meet all eligibility criteria will use the study system overnight at home for about 5 nights to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Patients who successfully demonstrate their ability to use the system as described above will be eligible for the randomized trial phase. This phase consists of use of the full system as an outpatient for approximately 21 nights:
- Each night the blood glucose level will be checked with the study blood glucose (BG) meter and used to perform a calibration of the CGM. The calibration must occur no more than 90 minutes prior to activation of the system. NOTE: Patients will be instructed to calibrate the CGM per manufacturer guidelines.
- Then the system will be activated, linking the CGM and insulin pump to the computer at the bedside.
- A randomization schedule on the laptop will be used to determine whether the 'pump shut off' application will be active that night or not.
- Patients will be blinded as to whether the pump shut off is active when a session is initiated each night.
- There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL. When a CGM alarm occurs, the patient will be asked to measure the blood glucose with a BG meter, if he/she is aware of the alarm.
- The time period for outcome assessment each night will be from the time the system is activated until it is turned off in the morning.
- Pump shut off, when it occurs, will be for up to 2 hours. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
- Patients will be asked to check blood glucose with the study BG meter, blood ketones with the study ketone meter, and urine ketones with a ketone strip each morning prior to breakfast and enter the results on the study laptop. The patient will be instructed to contact the study physician if the blood glucose or ketone readings are out of an expected range. Patients will be contacted if these morning safety values are not reported as required or are out of range.
- Patients will be asked to record all overnight carbohydrate intake on the study laptop.
- Patients will be asked to perform periodic data uploads using the study laptop. Monitoring processes will ensure that the patient is contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or urine ketone values.
Upon completion of the study, patients as well as study clinicians will be asked to complete a questionnaire regarding use of the study system.
There will a follow-up visit after completion of 21 successful nights of study system use. A successful night of study system use is defined as use of the system for at least four hours. Phone contacts with the patients will be made once a week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predictive pump suspension algorithm | Active comparator | Device: Pump suspensionThe study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. |
| Standard of Care | No intervention | –The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months
- Age >=18.0 years
- HbA1c <=8.0%
- Availability of internet access for periodic upload of study data
- Experience using the Medtronic pump and CGM and investigator is confident that subject will use CGM on a near-daily basis during the study
Key exclusion criteria (10 listed)
- Diabetic ketoacidosis in the past 3 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder (except for hypoglycemic seizure)
- Coronary artery disease or heart failure
- Cystic fibrosis
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 |
|---|---|---|
| Pump suspensionThe study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend. | Device | Predictive pump suspension algorithm |
Primary outcome
Mean Morning Blood Glucose (mg/dL)- Algorithm 1
Time frame: 21 study nights
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes.
Mean Morning Blood Glucose (mg/dL)- Algorithm 2
Time frame: 21 study nights
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2.
Mean Morning Blood Glucose (mg/dL)- Algorithm 3
Time frame: 21 study nights
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3.
Percent Morning Blood Glucose >250 mg/dL - Algorithm 1
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
Percent Morning Blood Glucose >250 mg/dL - Algorithm 2
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
Percent Morning Blood Glucose >250 mg/dL - Algorithm 3
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.
Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.
Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.
Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.
Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.
Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3
Time frame: 21 days
The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.
6 secondary outcomes
Mean Sensor Glucose Overnight - Algorithm 1
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Mean Sensor Glucose Overnight - Algorithm 2
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Mean Sensor Glucose Overnight - Algorithm 3
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23883408Buckingham BA, Cameron F, Calhoun P, Maahs DM, Wilson DM, Chase HP, Bequette BW, Lum J, Sibayan J, Beck RW, Kollman C. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-7. doi: 10.1089/dia.2013.0040. Epub 2013 Jul 24.
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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.
Bruce A Buckingham, MD study chair
Stanford University
Roy W Beck, MD, PhD principal investigator
Jaeb Center for Health Research
John Lum, MS study director
Jaeb Center for Health Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pump suspension in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 2 sites in United States.
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 10 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Morning Blood Glucose (mg/dL)- Algorithm 1 (time frame: 21 study nights). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736930, which also lists 1 linked publication.
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 30 Aug 2016.