Type 1 DiabetesEarly Phase 1IPCLNCT01787318
Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
A Early Phase 1 study testing ePID closed loop system and InsuPatch in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial summary
This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- ePID closed loop system and InsuPatch
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2015
- Phase
- Early Phase 1
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 12-40 years
- clinical diagnosis of type 1 diabetes
- duration of type 1 diabetes ≥ 1 year
- HbA1c ≤ 9 %
- Treated with pump therapy for at least 3 months
- Body weight > 40 kg
Who cannot join
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of poor wound healing, heat sensitivity, or diminished skin integrity.
- History of hypoglycemic seizure within last 3 months
- Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum creatinine)
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
- Subjects unable to give consent / permission / assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Effect of the Insupatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.
Read the detailed description
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an external insulin pump comparing the peak post-prandial glucose levels and the post-prandial glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient hospital research unit (HRU) setting. The closed loop visit consists of approximately 67 hours over 4 days and 3 nights.
- Conditions
- Type 1 Diabetes
- Being tested
- ePID closed loop system, InsuPatch
- 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.
ePID closed loop systemDevice
Insulin pump controlled by closed loop unit and algorithm
InsuPatchDevice
device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site
| Study group | Role | What they receive |
|---|---|---|
| ePID closed loop system using Insupatch | Experimental | Insupatch activated at mealtimes Receives: Device: ePID closed loop system; Device: InsuPatch |
| ePID closed loop system without InsuPatch | Active comparator | InsuPatch will not be activated at mealtimes Receives: Device: ePID closed loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Post-Prandial Glucose Excursions
Peak post-prandial plasma glucose excursions after breakfast, lunch, and dinner on days #2 and #3. One day with InsuPatch activated and one day without InsuPatch activated
Measured: 48 hours
Secondary outcomes (6)
Total Area Under Curve of the meal-related glucose excursion over target
Measured: 48 hours
Nadir glucose levels following the meals
Measured: 48 hours
Mean 24 hour glucose levels
Measured: 48 hours
Mean daytime and nighttime glucose levels
Measured: 48 hours
Peak post-prandial insulin levels following meals
Measured: 48 hours
Area Under Curve meal-related insulin excursion following meals
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionDec 2015
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Weinzimer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787318
- Sponsor's protocol ID
- HIC # 1208010682
- Acronym
- IPCL
- Status last verified
- Apr 2016
- First submitted
- 16 Jan 2013
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Insupatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01787318
- Acronym / sponsor ID
- IPCL / HIC # 1208010682
- Conditions
- Type 1 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Feb 2013 (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.
This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.
Detailed description
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an external insulin pump comparing the peak post-prandial glucose levels and the post-prandial glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient hospital research unit (HRU) setting. The closed loop visit consists of approximately 67 hours over 4 days and 3 nights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ePID closed loop system using Insupatch | Experimental | Device: ePID closed loop system, Device: InsuPatchInsupatch activated at mealtimes |
| ePID closed loop system without InsuPatch | Active comparator | Device: ePID closed loop systemInsuPatch will not be activated at mealtimes |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- age 12-40 years
- clinical diagnosis of type 1 diabetes
- duration of type 1 diabetes ≥ 1 year
- HbA1c ≤ 9 %
- Treated with pump therapy for at least 3 months
Key exclusion criteria (8 listed)
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of poor wound healing, heat sensitivity, or diminished skin integrity.
- History of hypoglycemic seizure within last 3 months
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 |
|---|---|---|
| ePID closed loop systemInsulin pump controlled by closed loop unit and algorithm | Device | ePID closed loop system using Insupatch, ePID closed loop system without InsuPatch |
| InsuPatchdevice which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site | Device | ePID closed loop system using Insupatch |
Primary outcome
Peak Post-Prandial Glucose Excursions
Time frame: 48 hours
Peak post-prandial plasma glucose excursions after breakfast, lunch, and dinner on days #2 and #3. One day with InsuPatch activated and one day without InsuPatch activated
6 secondary outcomes
Total Area Under Curve of the meal-related glucose excursion over target
Time frame: 48 hours
Nadir glucose levels following the meals
Time frame: 48 hours
Mean 24 hour glucose levels
Time frame: 48 hours
Mean daytime and nighttime glucose levels
Time frame: 48 hours
Peak post-prandial insulin levels following meals
Time frame: 48 hours
Area Under Curve meal-related insulin excursion following meals
Time frame: 48 hours
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 14 Apr 2016.
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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.
Stuart Weinzimer, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ePID closed loop system and InsuPatch in people with Type 1 Diabetes, run by Yale University 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 6 inclusion and 8 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 14 Apr 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Peak Post-Prandial Glucose Excursions (time frame: 48 hours). 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 14 Apr 2016.