Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Plasma Glucose (PG) Response to Exercise
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase
Closed Loop (CL) Phase
Closed Loop (CL) Phase
干预措施: Closed Loop (Device)
结局指标
主要结局
Plasma Glucose (PG) Response to Exercise
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Peak Post-prandial Plasma Glucose (PG)(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(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)(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.(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.(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.(Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.)