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Type 1 Diabetes MellitusPhase 2AP HybridNCT02153190

Hybrid Artificial Pancreas in Home Setting

A Phase 2 study testing HYBRID and OPEN in people with Type 1 Diabetes Mellitus and Treatement by Insulin Pump, run by University Hospital, Montpellier at 3 sites in 3 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

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
HYBRID and OPEN
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesin 3 countries
Study dates
May 2014to Jun 2015
Phase
Phase 2
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

  • Age ≥ 18 et < 70 years old
  • Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
  • Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
  • BMI < 35 kg/m²
  • Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
  • Trained in carbohydrate counting
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  • HbA1c > 7.5 % and < 10%
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
  • Willing to undergo all study procedures
  • Informed consent signed

Who cannot join

  • Pregnancy or breast feeding, or intention to be pregnant during the study duration
  • Use of a medication that significantly impacts glucose metabolism, e.g. steroids
  • Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
  • Patient plans to go abroad during the trial period
  • Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
  • Patient does not hold any nearby party for assistance if needed
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  • Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
  • Presence of any malignant disease, unless considered as cured for more than 10 years
  • History of acute cardiovascular event during the prior year
  • History of diabetic keto-acidosis during the prior 6 months
  • Renal insufficiency with creatinin > 150 μmol/L
  • Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
  • Impaired cognitive or psychological abilities which may result in defective adherence to study conditions

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

France1 site

  • CHU Montpellier

    Montpellier, 34000

Other trials in France

Italy1 site

  • University of Padova

    Padova

Other trials in Italy

Netherlands1 site

  • University of Amsterdam

    Amsterdam

Other trials in Netherlands

About this study

Official title: Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

Read the detailed description

During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

Being tested
HYBRID, OPEN
Keywords
Type 1 Diabetes,, T1DM,, Artificial Pancreas
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.

  • HYBRIDDevice

    During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.

  • OPENDevice

    During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

Study groups in NCT02153190
Study groupRoleWhat they receive
HYBRID-OPENExperimentalPatients are randomized on the schedule; hybrid period and after open period. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
Receives: Device: HYBRID; Device: OPEN
OPEN-HYBRIDExperimentalPatients are randomized on the schedule: open period and after hybrid period. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
Receives: Device: HYBRID; Device: OPEN

What is being measured

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

  1. Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period

    Measured: during 2 months-hybrid period and during 2 months-open period

Secondary outcomes (1)

  1. Low Blood Glucose Index (LBGI)

    Measured: for each period of 2 month (hybrid period and open period)

Timeline

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

  1. First posted2 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153190
Sponsor's protocol ID
8628 4
Acronym
AP Hybrid
Status last verified
Nov 2015
First submitted
29 May 2014
Last updated
6 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.

    PubMed 27208331

  • Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.

    PubMed 26432775

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HYBRID and OPEN in people with Type 1 Diabetes Mellitus and Treatement by Insulin Pump, run by University Hospital, Montpellier at 3 sites in 3 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 10 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 6 Nov 2015. 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 France, Italy, Netherlands. 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?

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?

Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period (time frame: during 2 months-hybrid period and during 2 months-open period). 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 NCT02153190, which also lists 2 linked publications.

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 6 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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