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Citation
Tonascia, James (2020). Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT) (Version 2) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/j1jk-ct53
Data Availability Statement
Data from the Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT) [(Version 2) https://doi.org/10.58020/j1jk-ct53] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The GLUMIT study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the GLUMIT (https://doi.org/10.58020/j1jk-ct53) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the GLUMIT study and does not necessarily reflect the opinions or views of the GLUMIT study, NIDDK-CR, or NIDDK.
Data Package Version
Version 2 (Updated on: Oct 12, 2020)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
Publications
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General Description

For diabetics with gastroparesis, unpredictable gastric emptying rates and uncertainties in nutrient absorption can lead to difficulties in managing glycemia. The utility of continuous glucose monitoring (CGM), which quantifies real time glucose excursions, in planning periprandial insulin dosing for diabetic patients with gastroparesis has not been explored. The Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) study is a multicenter, uncontrolled clinical trial that was established by the Gastroparesis Clinical Research Consortium (GpCRC) to assess the safety and utility of CGM in guiding insulin pump therapy in patients with type 1 and type 2 diabetes and gastroparesis.

Individuals with symptoms of gastroparesis, a Gastroparesis Cardinal Symptom Index (GCSI) score of 18, and diabetes for at least 2 years are enrolled in the study. Participants are treated using a combination of CGM and insulin pump therapy. The primary outcome measure, the frequency of mild and moderate (glucose level < 70 mg/dL) and severe hypoglycemic episodes while undergoing therapy, is assessed at 12 and 24-week follow-up visits. CGM data are related to finger stick levels and HbA1c values to test comparability of CGM and finger stick values. The efficacy of CGM-guided insulin pump therapy on symptoms of gastroparesis, quality of life, satiety, gastric myoelectrical activity, and autonomic function are also evaluated as a secondary outcome measures.

Objectives

The study aimed to evaluate the safety and 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.

Outcome Measure

The primary outcome measure, the frequency of mild and moderate (glucose level < 70 mg/dL) and severe hypoglycemic episodes while undergoing therapy, is assessed at 12 and 24-week follow-up visits. The efficacy of CGM-guided insulin pump therapy on symptoms of gastroparesis, quality of life, satiety, gastric myoelectrical activity, and autonomic function are also evaluated as a secondary outcome measures.

Eligibility Criteria

Individuals between the ages of 18-70 years who met the following criteria were eligible for the study:

  • Type 1 or Type 2 diabetes mellitus for at least 2 years
  • Symptoms of gastroparesis for at least 1 year prior to registration
  • Gastroparesis Cardinal Symptom Index (GCSI) score of 18
  • Delayed gastric emptying on gastric scintigraphy within 1 year of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
  • Hemoglobin A1c of at least 8.0% at registration regardless of current therapy
  • Normal upper endoscopy within 1 year of registration
  • No clinical or imaging evidence of obstruction
  • Successful mastering use of GMS during the run-in period
Outcome

Preliminary analysis has shown excellent comparability between CGM and finger stick values (random Bland-Altman plot, 95% limits of agreement = -55 to +52 mg/dL, and Pearson's correlation = 0.95 [p<0.001]).

Research Area

Digestive Diseases, Diabetes, Multidisciplinary Research

Study Type

Interventional

Study Sites

7

Study Start Date

2011-05

Study End Date

2015-01

Condition

Gastroparesis, Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus

Keywords

Continuous Glucose Monitoring (CGM), Glycemia, Diabetes, Gastroparesis, Gastroparesis Cardinal Symptom Index (GCSI), Gastric Myoelectrical Activity, Insulin Pump therapy, Clinical Trial, Glycemic Control

NIDDK Division

Division of Digestive Diseases and Nutrition

45
Participants

Target Population
Adults

Sex

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Age

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Race

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Ethnicity

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Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
Download
GLUMIT-DG Data Dictionary
Data Dictionary used as a collection of metadata - defines the variable contents of each dataset (version: April 9, 2020)Codebook/Data DictionaryPDF

Permitted Use(s) of the Resources
  • Use is allowed for health, medical, or biomedical research purposes
Non-Public Documents (1)
Non-Public Documents Table
Document Name
Description
Document Type
File Format
GLUMIT Informed Consent Statement
Consent form for GLUMIT-DG StudyConsent Form TemplatePDF
Datasets (11)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
EGG and Caloric Satiety Test Dataset
Captures results from EGG and Caloric Satiety Test118sas7bdat (300 KB); csv (89.03 KB)
Variable Names
  • id
  • study
  • study_txt
  • subject_id
  • repos_id
  • visit
  • form
  • st108
  • st108a
  • st109a
  • st109b
  • st109c
  • st109d
  • st109e
  • st110
  • st111
  • st112
  • st113a
  • st113b
  • st113c
  • st113d
  • st113e
  • st114a
  • st114b
  • st114c
  • st114d
  • st114e
  • st115a
  • st115b
  • st115c
  • st115d
  • st115e
  • st116a
  • st116b
  • st116c
  • st116d
  • st116e
  • st117
  • st118
  • st119
  • st120
  • st121
  • st122
  • st123
  • st124
  • st125a
  • st125b
  • st125c
  • st125d
  • st125e
  • st125f
  • st125g
  • st125h
  • st125i
  • st125j
  • st125k
  • st125l
  • st125m
  • st125n
  • st125o
  • st125p
  • st125q
  • st125r
  • st125s
  • st125t
  • st125u
  • st125v
  • st125w
  • st125x
  • st125y
  • st125z
  • st125aa
  • st125ab
  • st126a
  • st126b
  • st126c
  • st126d
  • st126e
  • st126f
  • st126g
  • st126h
  • st126i
  • st126j
  • st126k
  • st126l
  • st126m
  • st126n
  • st126o
  • st126p
  • st126q
  • st126r
  • st126s
  • st126t
  • st126u
  • st126v
  • st126w
  • st126x
  • st127a
  • st127b
  • st127c
  • st127d
  • st127e
  • st127f
  • st127g
  • st127h
  • st127i
  • st127j
  • st127k
  • st127l
  • st127m
  • st127n
  • st127o
  • st127p
  • st127q
  • st127r
  • st127s
  • st127t
  • st127u
  • st127v
  • st127w
  • st127x
  • st127y
  • st127z
  • st127aa
  • st127ab
  • st128a
  • st128b
  • st128c
  • st128d
  • st128e
  • st128f
  • st128g
  • st129a
  • st129b
  • st129c
  • st129d
  • st129e
  • st129f
  • st129g
  • st129h
  • st129i
  • st129j
  • st129k
  • st129l
  • st129m
  • st129n
  • st129o
  • st129p
  • st129q
  • st129r
  • st129s
  • st129t
  • st129u
  • st129v
  • st129w
  • st129x
  • st129y
  • st129z
  • st129aa
  • st129ab
  • formdate
Physical Examination Dataset
Captures physical examination data126sas7bdat (240 KB); csv (34.58 KB)
Patient Assessment of Upper Gastrointestinal Disorders Symptoms Severity Index (PAGI-SYM) Dataset
Captures results from Patient Assessment of Upper Gastrointestinal Disorders Symptoms Severity Index (PAGI-SYM)127sas7bdat (128 KB); csv (21.76 KB)
Follow-Up Medical History Dataset
Captures follow-up medical history data250sas7bdat (256 KB); csv (129.78 KB)
Registration Dataset
Captures registration data45sas7bdat (128 KB); csv (5.18 KB)
Laboratory Results Dataset
Captures laboratory results data127sas7bdat (128 KB); csv (22.13 KB)
Upper Endoscopy Dataset
Captures upper endoscopy data45sas7bdat (128 KB); csv (7.55 KB)
EGG and Water Load Satiety Test Dataset
Captures results from EGG and Water Load Satiety Test118sas7bdat (192 KB); csv (55.51 KB)
Gastric Emptying Scintigraphy Documentation Dataset
Captures gastric emptying scintigraphy data45sas7bdat (128 KB); csv (7.89 KB)
Baseline Medical History Dataset
Captures baseline medical history data45sas7bdat (128 KB); csv (26.54 KB)
Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) Dataset
Captures results from Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL)127sas7bdat (128 KB); csv (22.15 KB)
Specimens (1,151)
Specimens Table
Specimen
Count
Plasma1151