Trial Outcomes & Findings for Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (NCT NCT01030341)
NCT ID: NCT01030341
Last Updated: 2022-02-09
Results Overview
The incidence rate (events / person-week) of mild/moderate (glucose level \< 70 mg/dL) and severe (glucose \< 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
4 weeks screening vs 24 weeks follow-up
Results posted on
2022-02-09
Participant Flow
Forty-five patients (age 18-70 years) with diabetes for \>2 years in poor glycemic control (HbA1c \>8%) with gastroparesis were recruited from 7 centers of the GpCRC from February 2012 through May 2014. Patients had symptoms for \>1 year with Gastroparesis Cardinal Symptom Index (GCSI) scores of ≥18.
Screening Phase-Baseline glycemic profiles were obtained with blinded sensors to acquire \>216 hours of glycemic data over 2 weeks. Run-In Phase:Participants received detailed instructions in operating the CSII device and had to demonstrate competency in CSII and CGM and electronic CGM data transfer to be enrolled.
Participant milestones
| Measure |
All Participants
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Participants
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
Baseline characteristics by cohort
| Measure |
All Participants
n=45 Participants
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
|
Known diabetes duration
|
21 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Body mass index
|
29 kg/m^2
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Hemoglobin A1c
|
9.4 percentage
STANDARD_DEVIATION 1.4 • n=99 Participants
|
|
2 hr gastric retention
|
63 percentage
STANDARD_DEVIATION 20 • n=99 Participants
|
|
4 hr gastric retention
|
32 percentage
STANDARD_DEVIATION 20 • n=99 Participants
|
|
GCSI score
|
3.3 units on a scale
STANDARD_DEVIATION 0.8 • n=99 Participants
|
|
PAGI-QOL
|
2.4 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
|
Volume of Water consumed for water load satiety test
|
430 mL
STANDARD_DEVIATION 207 • n=99 Participants
|
|
Volume consumed in a liquid nutrient satiety test
|
420 mL
STANDARD_DEVIATION 258 • n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeks screening vs 24 weeks follow-upPopulation: 44 patients had non-missing data during screening phase and 37 had non-missing data during treatment phase
The incidence rate (events / person-week) of mild/moderate (glucose level \< 70 mg/dL) and severe (glucose \< 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy.
Outcome measures
| Measure |
All Participants
n=44 Participants
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Hypoglycemic Episodes
Screening phase, hypoglycemia / person-week
|
1.9 event rate per person-week
|
|
Hypoglycemic Episodes
Treatment phase, hypoglycemia / person-week
|
2.2 event rate per person-week
|
SECONDARY outcome
Timeframe: Change from baseline (screening) vs 24 weeks of follow-upTo determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis as assessed by GCSI total score and mean score and quality of life as assessed by PAGI-QOL score in diabetics with gastroparesis. The outcome is assessed using the self-reported total GCSI score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item postprandial fullness/early satiety subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5. The self-reported PAGI-QOL total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected in the last 2 weeks.The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks.
Outcome measures
| Measure |
All Participants
n=45 Participants
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Change in total GCSI score, screening to 12 weeks
|
-7.2 score on a scale
Standard Deviation 8.2
|
|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Change in GCSI composite, screening to 24 weeks
|
-0.8 score on a scale
Standard Deviation 1.0
|
|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Change in PAGI-QOL score, screening to 12 weeks
|
0.7 score on a scale
Standard Deviation 0.9
|
|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Change in PAGI-QOL score, screening to 24 weeks
|
0.7 score on a scale
Standard Deviation 0.9
|
|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Change in total GCSI score, screening to 24 weeks
|
-7.1 score on a scale
Standard Deviation 9.1
|
|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Change in GCSI composite, screening to 12 weeks
|
-0.6 score on a scale
Standard Deviation 0.9
|
Adverse Events
All Participants
Serious events: 16 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=45 participants at risk
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Metabolism and nutrition disorders
Severe hypoglycemic events, screening/run-in phase
|
4.4%
2/45 • Number of events 2
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Metabolism and nutrition disorders
Severe hypoglycemic events, treatment phase
|
14.3%
6/42 • Number of events 6
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Metabolism and nutrition disorders
Severe hyperglycemic events, treatment phase
|
7.1%
3/42 • Number of events 3
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Severe gastroparesis exacerbation, screening/run-in phase
|
2.2%
1/45 • Number of events 2
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Severe gastroparesis exacerbation, treatment phase
|
2.4%
1/42 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Nervous system disorders
Pain, numbness, paresthesia in hands, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Eye disorders
Retinal detachment, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
General disorders
Death of unknown cause, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Cardiac disorders
Heart attack, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, treatment phase
|
7.1%
3/42 • Number of events 3
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
Other adverse events
| Measure |
All Participants
n=45 participants at risk
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump
|
|---|---|
|
Gastrointestinal disorders
Non-severe gastroparesis exacerbation, screening/run-in phase
|
4.4%
2/45 • Number of events 2
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Non-severe gastroparesis exacerbation, treatment phase
|
4.8%
2/42 • Number of events 5
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Metabolism and nutrition disorders
Non-severe hyperglycemia, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Surgical and medical procedures
Cholecystectomy, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Ear and labyrinth disorders
Bilateral otitis externa, treatment phase
|
2.4%
1/42 • Number of events 2
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching rash under CGMS site, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Skin and subcutaneous tissue disorders
Rash generalized over upper body at CGMS site, treatment phase
|
2.4%
1/42 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, screening/run-in phase
|
4.4%
2/45 • Number of events 5
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, treatment phase
|
4.8%
2/42 • Number of events 2
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
|
Nervous system disorders
Tingling, disorientation, dizziness, screening/run-in phase
|
2.2%
1/45 • Number of events 1
Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place