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Type 1 DiabetesPHM2NCT02438189

Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms

A study testing Predictive Hyperglycemia Minimization Algorithm and Predictive Hypoglycemia Minimization Algorithm in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data. Read more about this study

Who is it for?
Ages 15 to 45 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Predictive Hyperglycemia Minimization Algorithm and Predictive Hypoglycemia Minimization Algorithm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesin 2 countries
Study dates
Jun 2015to Mar 2016
Phase
Interventional
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 15 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, 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 The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
  • Age 15.0 to <46.0 years
  • HbA1c <10.0%
  • Measured with DCA2000 or equivalent device for assessing eligibility
  • HbA1c measurements performed as part of usual clinical care within 2 weeks prior to obtaining informed consent for participation in the trial may be used.
  • Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning
  • Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night
  • An understanding of and willingness to follow the protocol and sign the informed consent

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)
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • 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 13Show fewer
  • History of ongoing renal disease (other than microalbuminuria). Creatinine level must have been obtained within the last year if subject has diabetes of >10 years duration. If creatinine is >1.5 mg/dL (132 µmol/L), the subject is excluded.
  • 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
  • Abuse of alcohol
  • Pregnancy Negative urine pregnancy test required for females who have experienced menarche as well as agreement from subject and parent/guardian to use a form of contraception to prevent pregnancy while participant is in the study. Subjects who become pregnant will be discontinued from the study.
  • Liver disease as defined by an ALT greater than 3 times the upper limit of normal

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Stanford University

    Stanford, California, 94305

Other trials in United States

Canada1 site

  • St. Joseph's Health Care

    London, Ontario, N6A4V2

Other trials in Canada

About this study

Official title: Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing

Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data.

Study Design: randomized controlled trial, with randomization on a night level within subject.

Read more

Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness in last 6 months; Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night.

Sample Size: 30 subjects.

Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use.

Major Efficacy Outcomes:

  • Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
  • Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.

Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis.

Read the detailed description

Subjects who are eligible for the clinical trial initially will use a Veo insulin pump and Enlite 2 CGM sensor at home for a minimum of 6 days/week over a 2-week period to verify that the subject is able to use the CGM and insert sensors.

The first 10 subjects enrolled will participate in a 2-day overnight hotel-based pilot, collecting a total of 20 nights of data and experience with the system in a transitional hotel setting. The DSMB will review safety data from the 20 night hotel-based pilot study and make recommendations regarding proceeding to the at-home portion of the study.

Following DSMB review and approval of the safety data from the hotel study, the first 10 subjects will participate in an Algorithm Assessment Phase of approximately 10 nights of Predictive Low Glucose Suspend (PLGS) + Hyper Minimization system use each (for a nominal total of 100 nights of use at home) to determine if any adjustments to the algorithm parameters are needed and if it is safe to advance to the randomized clinical trial phase. If adjustments are needed, the Algorithm Assessment Phase will be repeated, using the same 10 subjects if possible. Once the randomized clinical trial phase begins, approximately 200 nights of randomized system use will be collected and assessed for safety by the DSMB before proceeding.

New subjects who enroll in the study after the completion of the Algorithm Assessment Phase will use the PLGS+Hyper Minimization closed-loop system at home for at least 5 days to demonstrate their ability to use the system and submit study data to the Coordinating Center.

Subjects who successfully demonstrate their ability to use the system at home as described above will be eligible for the randomized trial phase. This phase consists of use of the full system in the home for approximately 42 nights:

  • Each night the blood glucose level will be checked with the BG meter and used to perform a calibration of the CGM. This calibration must occur no more than 90 minutes prior to activation of the system. NOTE: Subjects 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 system will run in PLGS+Hyper Minimization mode or PLGS-only.
  • Subjects will be blinded as to whether the system is running in PLGS+Hyper Minimization mode or PLGS-only.
  • There will not be an alarm if the pump shuts off or if automated insulin dosing occurs. The CGM alarm will be set to 60 mg/dL (3.3 mmol/L). When a CGM alarm occurs, the subject 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 120 minutes in a 150-minute period, and no more than 180 minutes for the entire night. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
  • Small correction boluses of insulin will be delivered when the system predicts that hyperglycemia above a pre-set threshold will occur, with insulin-on-board constraints and cumulative delivery limits to minimize the likelihood of excessive insulin delivery.
  • Subjects will be asked to check blood glucose with the study BG meter each morning prior to breakfast and enter the results using the controller software interface. The subject will be instructed to contact the study physician if the morning blood glucose value is <60 mg/dl (3.3 mmol/L) or >300 mg/dl (16.7 mmol/L). Monitoring processes detailed in section 3.11 will ensure that the subject can be contacted if these values are not reported as required or are out of range.
  • Subjects will be asked to record all overnight carbohydrate intake using the controller software interface.
  • Subjects will be asked to perform periodic CGM data uploads using the controller software interface. Monitoring processes will ensure that the subject can be contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of hypoglycemia or hyperglycemia, or elevated morning blood glucose values.

Upon completion of the study, subjects as well as study clinicians will be asked to complete a human factors usability questionnaire regarding use of the study system.

Conditions
Type 1 Diabetes
Being tested
Predictive Hyperglycemia Minimization Algorithm, Predictive Hypoglycemia Minimization Algorithm
Keywords
Type 1 Diabetes, Hypoglycemia, Hyperglycemia, Artificial Pancreas
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Predictive Hyperglycemia Minimization AlgorithmDevice

    A predictive hyperglycemia minimization algorithm designed to deliver automated correction boluses when the estimated glucose is predicted to exceed 140 mg/dL

  • Predictive Hypoglycemia Minimization AlgorithmDevice

    Also called Predictive Low Glucose Suspension (PLGS)

    A predictive hypoglycemia minimization designed to suspend the pump if the current sensor glucose is ≤70 mg/dL at any time or <230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes

Study groups in NCT02438189
Study groupRoleWhat they receive
Predictive Low Glucose Suspend (PLGS)Active comparatorA predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or <230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes. Basal insulin was restored on the first sensor rise during insulin suspension, and suspension time could not exceed 120 minutes in a 150 minute window or a cumulative total of 180 minutes per night.
Receives: Device: Predictive Hypoglycemia Minimization Algorithm
Predictive Hyper/Hypo Minimizer (PHHM)ExperimentalA predictive hyperglycemia minimization algorithm ran actively on the study laptop during the night and delivered automated correction boluses when the estimated glucose was predicted to exceed 140 mg/dL. In addition, a predictive hypoglycemia minimization algorithm ran and suspended the pump if the current sensor glucose was ≤70 mg/dL at any time or <230 mg/dL and predicted to fall below 80 mg/dL in the next 50 minutes.
Receives: Device: Predictive Hyperglycemia Minimization Algorithm; Device: Predictive Hypoglycemia Minimization Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Time Spent 70-180 mg/dL

    Mean percent of time participant spent with glucose values 70-180 mg/dl, measured by continuous glucose monitor of each night

    Measured: Up to 42 nights

Secondary outcomes (15)

  1. Mean Sensor Glucose

    Mean CGM sensor glucose

    Measured: Up to 42 nights

  2. Percent Time Spent <50 mg/dL (2.8 mmol/L)

    Median percent of time participant spent with glucose values <50 mg/dl, measured by continuous glucose monitor of each night.

    Measured: Up to 42 nights

  3. Percent of Time Spent <60 mg/dL (3.3 mmol/L)

    Median percent of time participant spent with glucose values <60 mg/dl, measured by continuous glucose monitor of each night

    Measured: Up to 42 nights

  4. Percent Time Spent <70 mg/dL (3.9 mmol/L)

    Median percent of time participant spent with glucose values <70 mg/dl, measured by continuous glucose monitor of each night

    Measured: Up to 42 nights

  5. Percent Time Spent >180 mg/dL (10.0 mmol/L)

    Median percent of time participant spent with glucose values >180 mg/dl, measured by continuous glucose monitor of each night

    Measured: Up to 42 nights

  6. Percent Time Spent >250 mg/dL (13.9 mmol/L)

    Median percent of time participant spent with glucose values >250 mg/dl, measured by continuous glucose monitor of each night

    Measured: 42 nights

  7. Percent Time Spent >300 mg/dL (16.7 mmol/L)

    Median percent of time participant spent with glucose values >300 mg/dl (16.7 mmol/L), measured by continuous glucose monitor of each night

    Measured: Up to 42 nights

  8. Percent Time Spent >30 Min and >60 Min Consecutive <50 mg/dL (2.8 mmol/L)

    Percent of time participant spent >30 minutes and >60 minutes consecutively with glucose values <50 mg/dl (2.8 mmol/L) of all nights

    Measured: Up to 42 nights

  9. Percent Time Spent >30 Min and >60 Min Consecutively <60 mg/dL (3.3 mmol/L)

    Percent of time participant spent >30 minutes and >60 minutes consecutively with glucose values <60 mg/dl (3.3 mmol/mol) of all nights

    Measured: Up to 42 nights

  10. Percent Time Spent With >30 Min and >60 Min Consecutively <70 mg/dL (3.9 mmol/L)

    Percent of time participant spent with >30 min and >60 min consecutively <70 mg/dL (3.9 mmol/L) of all nights

    Measured: Up to 42 nights

  11. Glucose Coefficient of Variation (CV)

    Measured: Up to 42 nights

  12. Amount of Total Insulin Boluses

    Measured: Up to 42 nights

  13. Mean Home Glucose Meter Morning Glucose

    Measured: Up to 42 nights

  14. Percent of Mornings With Glucose >250 mg/dL (13.9 mmol/L)

    Percent of mornings participant spent with glucose >250 mg/dL (13.9 mmol/L), measured by home glucose monitor of all mornings

    Measured: Up to 42 nights

  15. Percent Time Spent 70 to 180 mg/dL (3.9 to 10.0 mmol/L) Overnight

    Percent of time participant spent with glucose values 70 to 180 mg/dl (2.8 mmol/L), measured by continuous glucose monitor, during each night

    Measured: Up to 42 nights

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Subjects are randomized on a per-night level for when the PHHM will be active or not.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02438189
Sponsor's protocol ID
PHM2
Other IDs
RFA-DK-08-012, 5R01DK085591-05
Acronym
PHM2
Status last verified
Jul 2026
First submitted
1 May 2015
Last updated
11 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No

Publications

  • Spaic T, Driscoll M, Raghinaru D, Buckingham BA, Wilson DM, Clinton P, Chase HP, Maahs DM, Forlenza GP, Jost E, Hramiak I, Paul T, Bequette BW, Cameron F, Beck RW, Kollman C, Lum JW, Ly TT; In-Home Closed-Loop (IHCL) Study Group. Predictive Hyperglycemia and Hypoglycemia Minimization: In-Home Evaluation of Safety, Feasibility, and Efficacy in Overnight Glucose Control in Type 1 Diabetes. Diabetes Care. 2017 Mar;40(3):359-366. doi: 10.2337/dc16-1794. Epub 2017 Jan 18.

    PubMed 28100606

Questions about this trial

What is this clinical trial studying?

A study testing Predictive Hyperglycemia Minimization Algorithm and Predictive Hypoglycemia Minimization Algorithm in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 3 sites in 2 countries.

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 8 inclusion and 13 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 11 Aug 2026). 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?

Percent Time Spent 70-180 mg/dL (time frame: Up to 42 nights). 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 NCT02438189, 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 11 Aug 2026.

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