The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
2017년 10월 19일 업데이트: Steven J. Russell, MD, PhD, Massachusetts General Hospital
The Summer Camp Study 2: Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population Ages 6-11 at the Clara Barton Diabetes Camps
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improve glycemic control vs. usual care for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.
연구 개요
연구 유형
중재적
등록 (실제)
19
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria
- Age 6-11 years with type 1 diabetes for at least one year
- Diabetes managed using an insulin infusion pump for ≥ three months
- Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)
- Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion)
Exclusion Criteria
- Unable to provide informed consent, informed assent or parental consent
- Unable to comply with study procedures
- Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis)
- Pregnancy (positive urine human chorionic gonadotropin [HCG])
- History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion
- Personal history of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma
- History of prolonged QT or arrhythmia, congenital heart disease or current known cardiac disease
- Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes (T1D) at the time of the study
- Seizure disorder, history of any seizure within the last two years, or ongoing treatment with anticonvulsants
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio-frequency (RF) interference
- Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (SGLT-2) inhibitors) anti-diabetic medications
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the comparator and bionic pancreas arms of the study
- History of eating disorder such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Bionic Pancreas
Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
|
Automated blood glucose control via a closed-loop bionic pancreas device.
다른 이름들:
|
|
실험적: Usual Care
Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
|
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
기간: Days 2 to 5 of each period
|
Glucose reading were taken every 5 minutes by the CGM.
The CGM glucose results during Days 2 through 5 were averaged.
|
Days 2 to 5 of each period
|
|
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
기간: Days 2 to 5 of each period
|
Glucose reading were taken every 5 minutes by the CGM.
The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 through 5 was calculated.
|
Days 2 to 5 of each period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean CGMG Values
기간: Day 1 and Days 1-5 in each period
|
Glucose reading were taken every 5 minutes by the CGM.
The glucose results for each time frame were averaged.
|
Day 1 and Days 1-5 in each period
|
|
Percentage of Time With CGMG Concentration by Ranges During Day 1
기간: Day 1 of each period
|
Glucose readings were taken every 5 minutes by the CGM.
The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL(2.8
mmol/L), < 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).
|
Day 1 of each period
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
기간: Days 1 to 5 of each period
|
Glucose readings were taken every 5 minutes by the CGM.
The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).
|
Days 1 to 5 of each period
|
|
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
기간: Days 2 to 5 of each period
|
Glucose readings were taken every 5 minutes by the CGM.
The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).
|
Days 2 to 5 of each period
|
|
Percentage of Participants With Mean CGMG Glucose <154 mg/dL
기간: Day 1, Days 1-5, and Days 2-5 of each period
|
Glucose reading were taken every 5 minutes by the CGM.
The glucose readings were averaged.
154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.
|
Day 1, Days 1-5, and Days 2-5 of each period
|
|
Percentage of Participants With Mean CGMG Glucose <169 mg/dL
기간: Day 1, Days 1-5, and Days 2-5 of each period
|
Glucose reading were taken every 5 minutes by the CGM.
The glucose readings were averaged.
169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
|
Day 1, Days 1-5, and Days 2-5 of each period
|
|
Percentage of Participants With Mean CGMG Glucose <183 mg/dL
기간: Day 1, Days 1-5, and Days 2-5 of each period
|
Glucose reading were taken every 5 minutes by the CGM.
The glucose readings were averaged.
183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
|
Day 1, Days 1-5, and Days 2-5 of each period
|
|
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
기간: Days 1-5
|
A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
|
Days 1-5
|
|
Mean Plasma Glucose Values
기간: Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The plasma glucose readings were averaged.
The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.
|
Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
|
Percentage of Time With Plasma Glucose Values by Ranges on Day 1
기간: Day 1 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).
|
Day 1 of each period
|
|
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
기간: Days 1 to 5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dL (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dL (2.8 mmol/L).
|
Days 1 to 5 of each period
|
|
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
기간: Days 2 to 5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).
|
Days 2 to 5 of each period
|
|
Percentage of Participants With Mean Plasma Glucose <154 mg/dL
기간: Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The plasma glucose readings were averaged.
154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.
|
Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
|
Percentage of Participants With Mean Plasma Glucose <169 mg/dL
기간: Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The plasma glucose readings were averaged.
169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
|
Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
|
Percentage of Participants With Mean Plasma Glucose <183 mg/dL
기간: Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
The plasma glucose readings were averaged.
183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
|
Day 1, Days 1 to 5, and Days 2 to 5 of each period
|
|
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
기간: Days 1-5
|
A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
|
Days 1-5
|
|
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
기간: Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
|
The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.
|
Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
|
|
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL
기간: Day 1, Days 1-5, and Days 2-5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L.
These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L.
A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.
The total number of carbohydrate interventions are reported.
|
Day 1, Days 1-5, and Days 2-5 of each period
|
|
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
기간: Day 1, Days 1-5, and Days 2-5 of each period
|
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements).
Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L.
These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L.
A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.
|
Day 1, Days 1-5, and Days 2-5 of each period
|
|
Insulin Total Daily Dose
기간: 11 days
|
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
|
11 days
|
|
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
기간: Day 1, Days 1-5, and Days 2-5 of each period
|
Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
|
Day 1, Days 1-5, and Days 2-5 of each period
|
|
Daily Basal Insulin Dose in the Bionic Pancreas Period
기간: Day 1 through Day 5
|
The bionic pancreas automatically adapted insulin dosing to each individual's needs.
When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days.
Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).
|
Day 1 through Day 5
|
|
Daily Bolus Insulin Dose in the Bionic Pancreas Period
기간: Day 1 through Day 5
|
The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered.
After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size.
Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).
|
Day 1 through Day 5
|
|
Carbohydrate Intake
기간: Day 1, Days 1-5 and Days 2-5
|
Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was <80 mg/dl (or for symptoms at any glucose level).
Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).
|
Day 1, Days 1-5 and Days 2-5
|
|
Number of Unscheduled Infusion Set Changes
기간: Day 1
|
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs.
Infusion set changes due to pain, infusion set falling out or infusion set failure are reported.
Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
|
Day 1
|
|
Number of Unscheduled Infusion Set Changes
기간: Days 1-5
|
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs.
Infusion set changes due to pain, infusion set falling out or infusion set failure are reported.
Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
|
Days 1-5
|
|
Number of Unscheduled Infusion Set Changes
기간: Days 2-5
|
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs.
Infusion set changes due to pain, infusion set falling out or infusion set failure are reported.
Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
|
Days 2-5
|
|
Number of Bionic Pancreas Local Infusion Site Reactions
기간: Day 1, Days 1-5 and Days 2-5
|
Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas.
Itching and redness may have also been present.
|
Day 1, Days 1-5 and Days 2-5
|
|
Mean Nausea Index Score Using a Visual Analogue Scale (VAS)
기간: Day 1, Days 1-5, and Days 2-5 in each period
|
Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea.
The average nausea index scores from Day 1 to Day 5 were calculated
|
Day 1, Days 1-5, and Days 2-5 in each period
|
|
Number of Severe Hypoglycemic Events
기간: Day 1, Days 1-5 and Days 2-5
|
A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
|
Day 1, Days 1-5 and Days 2-5
|
|
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
기간: 5 days
|
Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
|
5 days
|
|
Percentage of Time Without CGM Monitoring Data
기간: 5 days
|
Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
|
5 days
|
|
Change From Baseline in Body Weight
기간: 5 days
|
The change in body weight collected at Day 5 of each period relative to Baseline.
A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.
|
5 days
|
|
Reliability Index
기간: Day 1, Days 1-5, and Days 2-5 in each period
|
Reliability index was calculated as the percentage of time values were actually recorded by CGM.
|
Day 1, Days 1-5, and Days 2-5 in each period
|
|
List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution
기간: 5 days
|
5 days
|
|
|
Number of Unscheduled CGM Sensor Changes
기간: 5 days
|
The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
|
5 days
|
|
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
기간: 5 days
|
The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
|
5 days
|
|
Percentage of Participants Using Pramlintide During the Usual Care Period
기간: 5 days
|
The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.
|
5 days
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 6월 1일
기본 완료 (실제)
2014년 8월 1일
연구 완료 (실제)
2014년 8월 1일
연구 등록 날짜
최초 제출
2014년 4월 2일
QC 기준을 충족하는 최초 제출
2014년 4월 2일
처음 게시됨 (추정)
2014년 4월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 10월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 10월 19일
마지막으로 확인됨
2017년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
제1형 당뇨병에 대한 임상 시험
-
Rhythm Pharmaceuticals, Inc.완전한Pro-opiomelanocortin(POMC), Proprotein Convertase Subtilisin/Kexin Type 1(PCSK1) 및 Leptin 수용체(LepR) 유전자 돌연변이미국, 이스라엘, 캐나다, 독일, 그리스, 이탈리아, 포르투갈
-
Duke Street Bio Ltd모병Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Metastases)스페인, 프랑스, 헝가리, 미국
-
RevBioNational Institute on Aging (NIA)아직 모집하지 않음AO/OTA Type 2R3C 원위 요골 골절
-
Chong Kun Dang Pharmaceutical완전한
-
Salzburger LandesklinikenMedizinische Einrichtungen der Universität Düsseldorf; Universitätsklinkum Münster - Medizinische... 그리고 다른 협력자들모병
-
Sohag Universitysohag university hospital모병
-
University Hospital Hradec Kralove완전한