Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

Type 1 Diabetes Mellitus Clinical Trial

— ePID-03  

Official title:

Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831389
• Other study ID #: ePID-03
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: November 9, 2017
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2017
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

Device:
• Closed Loop
Insulin pump controlled by closed loop unit and algorithm

Locations

Country	Name	City	State
United States	Yale Pediatrics Diabetes Research	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Diabetes	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose (PG) Response to Exercise	PG at start of exercise minus the subsequent PG nadir	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.
Primary	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.	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.
Primary	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.	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	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.	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.
Secondary	Nadir Plasma Glucose (PG) Immediately Following Exercise	The PG nadir observed following the start of exercise	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.
Secondary	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.	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.
Secondary	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.	Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Secondary	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.	Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Secondary	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.	Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.