HyperglycemiaNCT01291719
Insulin Balanced Infusion System
A study testing glucose and insulin infusions in people with Hyperglycemia and Diabetes, run by Admetsys Corporation at 1 site in United States.
Trial summary
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hyperglycemia, Diabetes
- What is being tested?
- glucose and insulin infusions
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%
- glucose at time of study > 150 mg/dl
Who cannot join
- pregnancy
- renal or hepatic disease
- corticosteroids
- poor intravenous access
- anemia
- electrolyte abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Balanced Infusion System Control of Glucose
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery
Read the detailed description
The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm
- Conditions
- Hyperglycemia, Diabetes
- Being tested
- glucose and insulin infusions
- Keywords
- closed loop glucose control, intensive care glucose control
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose and insulin infusionsDevice
combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl
| Study group | Role | What they receive |
|---|---|---|
| insulin and glucose infusion | Experimental | trial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system Receives: Device: glucose and insulin infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose control in target range
blood glucose measurements in target range (80-125 mg/dl)
Measured: data will be evaluated within 6 months after completion of all 40 studies
Secondary outcomes (1)
hypoglycemia
blood glucose <70 mg/dl
Measured: data will be evaluated within 6 months after all 40 studies are completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startNov 2008
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Insulin and glucose infusion in closed loop control; intervention is glucose control with insulin and glucose infusion
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Admetsys Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Timothy Valk MD, Admetsys Corporation
- Investigators
- Timothy W Valk, MD, Principal investigator, Admetsys Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291719
- Sponsor's protocol ID
- IBIS-1
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2011
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: with publication the data will be shared
Publications
Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Preliminary Study. J Diabetes Sci Technol. 2019 Sep;13(5):935-940. doi: 10.1177/1932296818821349. Epub 2019 Jan 24.
PubMed 30678470Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Advancing the Development. J Diabetes Sci Technol. 2019 Sep;13(5):941-948. doi: 10.1177/1932296819832876. Epub 2019 Mar 10.
PubMed 30854885
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Balanced Infusion System Control of Glucose
- ClinicalTrials.gov ID
- NCT01291719
- Acronym / sponsor ID
- IBIS-1
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- closed loop glucose control, intensive care glucose control
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Admetsys CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 8 Feb 2011 (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.
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery
Detailed description
The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Insulin and glucose infusion in closed loop control; intervention is glucose control with insulin and glucose infusion
| Arm | Type | Receives |
|---|---|---|
| insulin and glucose infusion | Experimental | Device: glucose and insulin infusionstrial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%
- glucose at time of study > 150 mg/dl
Key exclusion criteria (6 listed)
- pregnancy
- renal or hepatic disease
- corticosteroids
- poor intravenous access
- anemia
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 |
|---|---|---|
| glucose and insulin infusionscombined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl | Device | insulin and glucose infusion |
Primary outcome
glucose control in target range
Time frame: data will be evaluated within 6 months after completion of all 40 studies
blood glucose measurements in target range (80-125 mg/dl)
1 secondary outcome
hypoglycemia
Time frame: data will be evaluated within 6 months after all 40 studies are completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 30678470Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Preliminary Study. J Diabetes Sci Technol. 2019 Sep;13(5):935-940. doi: 10.1177/1932296818821349. Epub 2019 Jan 24.
- Results publication: PubMed 30854885Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Advancing the Development. J Diabetes Sci Technol. 2019 Sep;13(5):941-948. doi: 10.1177/1932296819832876. Epub 2019 Mar 10.
- Individual participant dataSharing planned: No. with publication the data will be shared
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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.
Timothy W Valk, MD principal investigator
Admetsys Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose and insulin infusions in people with Hyperglycemia and Diabetes, run by Admetsys Corporation at 1 site 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
glucose control in target range (time frame: data will be evaluated within 6 months after completion of all 40 studies). 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 NCT01291719, 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 27 Oct 2026.