Type 1 Diabetes MellitusePID-03NCT00831389
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
A study testing Closed Loop in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Closed Loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects between 12-30 years of age.
- Subjects must weigh at least 50 kg to accommodate phlebotomy.
- Previously diagnosed Type 1 Diabetes Mellitus
- Diabetes duration at least 1 year.
- Currently treating their diabetes with an insulin pump.
- A1C of ≤ 9.0 % at time of enrollment.
Show all 12Show fewer
- Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose if needed.
- Willing to wear two (2) subcutaneous glucose sensors and two (2) transmitters simultaneously during closed-loop portion of the study.
- Be in good general health without other acute or chronic illnesses except treated hypothyroidism or celiac disease and asthma not requiring glucocorticoid use.
- Able to tolerate a 75-minute exercise period of moderate intensity.
- Speak and understand English.
- Subject and parent (if minor) must be able to comprehend and sign the informed consent form and other study documents.
Who cannot join
- Pregnancy (urine pregnancy test) or lactation, if female.
- Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
- Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
- Subject using any of the following medications:
- glucocorticoids
- cyclosporine
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- L-asparaginase
- niacin
- protease inhibitors
- anti-psychotics
- GnRH agonists
- beta-blockers
- calcium channel blockers
- immunosuppressants
- over-the-counter medications that may effect glucose metabolism.
- Subject has any of the following conditions
- insulin allergy
- severe insulin resistance
- exercise-induced asthma
- musculoskeletal problems that may impact ability to complete exercise protocol
- substance abuse
- skin ulcers or poor wound healing
- bleeding disorders
- chronic infections
- eating disorders
- give a history of or are predisposed to major stress
- any other major organ system disease.
- Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
- Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
- Subjects using dietary supplements within 14 days of study enrollment
- Subject is currently enrolled in another study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Pediatrics Diabetes Research
New Haven, Connecticut, 06519
About this study
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
Read the detailed description
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise. Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop). The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Closed Loop
- 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.
Closed LoopDevice
Insulin pump controlled by closed loop unit and algorithm
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop (CL) Phase | Experimental | Closed Loop (CL) Phase Receives: Device: Closed Loop |
| Standard of Care (OL) Phase | No intervention | Standard of Care (OL) Phase or Open Loop Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose (PG) Response to Exercise
PG at start of exercise minus the subsequent PG nadir
Measured: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Incidence of Hypoglycemia Immediately Following Exercise
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Measured: Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
Incidence of Nocturnal Hypoglycemia Following Exercise
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Measured: Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
Secondary outcomes (6)
Peak Post-prandial Plasma Glucose (PG)
For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.
Measured: Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
Nadir Plasma Glucose (PG) Immediately Following Exercise
The PG nadir observed following the start of exercise
Measured: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Overnight Nadir Plasma Glucose (PG)
For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.
Measured: Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Measured: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Measured: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Measured: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
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 Diabetes MellitusStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Stuart Weinzimer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831389
- Sponsor's protocol ID
- ePID-03
- Acronym
- ePID-03
- Status last verified
- Nov 2017
- First submitted
- 26 Jan 2009
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sherr JL, Cengiz E, Palerm CC, Clark B, Kurtz N, Roy A, Carria L, Cantwell M, Tamborlane WV, Weinzimer SA. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2909-14. doi: 10.2337/dc13-0010. Epub 2013 Jun 11.
PubMed 23757427
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
- ClinicalTrials.gov ID
- NCT00831389
- Acronym / sponsor ID
- ePID-03 / ePID-03
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Posted 11 Oct 2012
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 the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
Detailed description
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise. Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop). The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Loop (CL) Phase | Experimental | Device: Closed LoopClosed Loop (CL) Phase |
| Standard of Care (OL) Phase | No intervention | –Standard of Care (OL) Phase or Open Loop Phase |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Male and female subjects between 12-30 years of age.
- Subjects must weigh at least 50 kg to accommodate phlebotomy.
- Previously diagnosed Type 1 Diabetes Mellitus
- Diabetes duration at least 1 year.
- Currently treating their diabetes with an insulin pump.
Key exclusion criteria (31 listed)
- Pregnancy (urine pregnancy test) or lactation, if female.
- Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
- Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
- Subject using any of the following medications:
- Subject has any of the following conditions
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 |
|---|---|---|
| Closed LoopInsulin pump controlled by closed loop unit and algorithm | Device | Closed Loop (CL) Phase |
Primary outcome
Plasma Glucose (PG) Response to Exercise
Time frame: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
PG at start of exercise minus the subsequent PG nadir
Incidence of Hypoglycemia Immediately Following Exercise
Time frame: Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Incidence of Nocturnal Hypoglycemia Following Exercise
Time frame: Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
6 secondary outcomes
Peak Post-prandial Plasma Glucose (PG)
Time frame: Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
Nadir Plasma Glucose (PG) Immediately Following Exercise
Time frame: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Overnight Nadir Plasma Glucose (PG)
Time frame: Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
Time frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
Time frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
Time frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23757427Sherr JL, Cengiz E, Palerm CC, Clark B, Kurtz N, Roy A, Carria L, Cantwell M, Tamborlane WV, Weinzimer SA. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2909-14. doi: 10.2337/dc13-0010. Epub 2013 Jun 11.
- Individual participant dataSharing planned: No
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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 study testing Closed Loop in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. 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 12 inclusion and 31 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 12 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 11 Oct 2012). 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?
Plasma Glucose (PG) Response to Exercise (time frame: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.). The study lists 3 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 NCT00831389, 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 12 Dec 2017.