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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK073983 | U.S. NIH Grant/Contract | View source | |
| U01DK073975 | U.S. NIH Grant/Contract | View source | |
| U01DK073985 | U.S. NIH Grant/Contract | View source | |
| U01DK074035 | U.S. NIH Grant/Contract | View source | |
| U01DK074008 | U.S. NIH Grant/Contract | View source | |
| U01DK073974 | U.S. NIH Grant/Contract | View source | |
| U01DK074007 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic control for treatment of type 1 and type 2 diabetic patients with gastroparesis
This multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS in guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGMS and insulin pump | Experimental | Continuous glucose monitoring in conjunction with insulin pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGMS and insulin pump | Device | Use of continuous glucose monitoring system and insulin pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic Episodes | 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. | 4 weeks screening vs 24 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score | To 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Hamilton, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94115 | United States | ||
| Stanford University |
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| Label | URL |
|---|---|
| Click here for information on gastroparesis research | View source |
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Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/glumit/?query=GLUMIT
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Continuous glucose monitoring in conjunction with insulin pump CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Continuous glucose monitoring in conjunction with insulin pump CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hypoglycemic Episodes | 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. | 44 patients had non-missing data during screening phase and 37 had non-missing data during treatment phase | Posted | Number | event rate per person-week | 4 weeks screening vs 24 weeks follow-up |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Continuous glucose monitoring in conjunction with insulin pump CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemic events, screening/run-in phase | Metabolism and nutrition disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-severe gastroparesis exacerbation, screening/run-in phase | Gastrointestinal disorders |
Our sample size and treatment durations were somewhat modest to compare severe hypoglycemic episodes and efficacy outcomes before and during treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Van Natta | Johns Hopkins Data Coordinating Center | 410-614-1362 | mvannat1@jhu.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Change from baseline (screening) vs 24 weeks of follow-up |
| Stanford |
| California |
| 94305-5187 |
| United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Known diabetes duration | Mean | Standard Deviation | years |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Hemoglobin A1c | Mean | Standard Deviation | percentage |
|
| 2 hr gastric retention | Mean | Standard Deviation | percentage |
|
| 4 hr gastric retention | Mean | Standard Deviation | percentage |
|
| GCSI score | The Gastroparesis Cardinal Symptom Index (GCSI) is the mean of 3 subscales: nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), and bloating (2 items). Subscale scores were calculated by averaging across items within a subscale. A 6-point Likert scale was used for scoring individual items ranging from 0 (none) to 5 (very severe). | Mean | Standard Deviation | units on a scale |
|
| PAGI-QOL | The Patient Assessment of Upper Gastrointestinal Disorders-Quality of LIfe (PAGI-QOL) contains 30 items with 5 subscales: (1) daily activities; (2) clothing; (3) diet/food habits; (4) relationship; and (5) psychological well-being and distress. Items are scored on a 6-point Likert scale, with response options ranging from 0 (none) to 5 (all of the time). Subscale scores are calculated by averaging the item responses within a each subscale after reversing item scores. A total score is calculated by averaging subscale scores, with higher values indicating improved quality of life. | Mean | Standard Deviation | units on a scale |
|
| Volume of Water consumed for water load satiety test | The Water Load Satiety Test involves drinking cool water over 5 minutes until full. The outcome of interest is the volume of water drank in mL. | Mean | Standard Deviation | mL |
|
| Volume consumed in a liquid nutrient satiety test | The liquid nutrient satiety test involves drinking Ensure in 5 minutes until full. The outcome of interest is the amount drank in mL. | Mean | Standard Deviation | mL |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score | To 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (screening) vs 24 weeks of follow-up |
|
|
|
|
| 16 |
| 45 |
| 12 |
| 45 |
| Severe hypoglycemic events, treatment phase | Metabolism and nutrition disorders |
|
| Severe hyperglycemic events, treatment phase | Metabolism and nutrition disorders |
|
| Severe gastroparesis exacerbation, screening/run-in phase | Gastrointestinal disorders |
|
| Severe gastroparesis exacerbation, treatment phase | Gastrointestinal disorders |
|
| Pain, numbness, paresthesia in hands, screening/run-in phase | Nervous system disorders |
|
| Retinal detachment, screening/run-in phase | Eye disorders |
|
| Death of unknown cause, screening/run-in phase | General disorders |
|
| Heart attack, screening/run-in phase | Cardiac disorders |
|
| Abdominal pain, nausea, vomiting, screening/run-in phase | Gastrointestinal disorders |
|
| Abdominal pain, nausea, vomiting, treatment phase | Gastrointestinal disorders | Also included anxiety in one case |
|
| Non-severe gastroparesis exacerbation, treatment phase | Gastrointestinal disorders |
|
| Non-severe hyperglycemia, screening/run-in phase | Metabolism and nutrition disorders |
|
| Cholecystectomy, screening/run-in phase | Surgical and medical procedures |
|
| Bilateral otitis externa, treatment phase | Ear and labyrinth disorders | Also included vomiting and diarrhea in one case |
|
| Pruritis/itching rash under CGMS site, screening/run-in phase | Skin and subcutaneous tissue disorders |
|
| Rash generalized over upper body at CGMS site, treatment phase | Skin and subcutaneous tissue disorders |
|
| Abdominal pain, nausea, vomiting, screening/run-in phase | Gastrointestinal disorders | Also included fever, cough, nasal congestion, and/or sore throat in some cases |
|
| Abdominal pain, nausea, vomiting, treatment phase | Gastrointestinal disorders | Also included dizziness, fainting, and/or diarrhea in some cases |
|
| Tingling, disorientation, dizziness, screening/run-in phase | Nervous system disorders |
|
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| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Change in GCSI composite, screening to 24 weeks |
|
| Change in PAGI-QOL score, screening to 12 weeks |
|
| Change in PAGI-QOL score, screening to 24 weeks |
|
| paired t-test |
| <0.0001 |
| Non-Inferiority or Equivalence (legacy) |
Mean change = 0 |
| Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment. | paired t-test | <0.0001 | Non-Inferiority or Equivalence (legacy) | Mean change = 0 |
| Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment. | paired t-test | <0.0001 | Non-Inferiority or Equivalence (legacy) | Mean change = 0 |
| Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment. | paired t-test | <0.0001 | Non-Inferiority or Equivalence (legacy) | Mean change = 0 |
| Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment. | paired t-test | <0.0001 | Non-Inferiority or Equivalence (legacy) | Mean change = 0 |