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Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)

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ClinicalTrials.gov Identifier: NCT01030341
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetic Gastroparesis
Intervention: Device: CGMS and insulin pump

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.


Reporting Groups
  Description
All Participants

Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump


Participant Flow:   Overall Study
    All Participants
STARTED   45 [1] 
COMPLETED   42 [2] 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Lost to Follow-up                2 
[1] 45 participants met all enrollment criteria by completing the screening and run-in phases
[2] 42 participants completed the study



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants

Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31  68.9% 
Male      14  31.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      11  24.4% 
Not Hispanic or Latino      34  75.6% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   45 
Known diabetes duration 
[Units: Years]
Mean (Standard Deviation)
 21  (11) 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29  (8) 
Hemoglobin A1c 
[Units: Percentage]
Mean (Standard Deviation)
 9.4  (1.4) 
2 hr gastric retention 
[Units: Percentage]
Mean (Standard Deviation)
 63  (20) 
4 hr gastric retention 
[Units: Percentage]
Mean (Standard Deviation)
 32  (20) 
GCSI score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.3  (0.8) 
[1] 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).
PAGI-QOL [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.4  (1.1) 
[1] 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.
Volume of Water consumed for water load satiety test [1] 
[Units: mL]
Mean (Standard Deviation)
 430  (207) 
[1] 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.
Volume consumed in a liquid nutrient satiety test [1] 
[Units: mL]
Mean (Standard Deviation)
 420  (258) 
[1] The liquid nutrient satiety test involves drinking Ensure in 5 minutes until full. The outcome of interest is the amount drank in mL.


  Outcome Measures

1.  Primary:   Hypoglycemic Episodes   [ Time Frame: 4 weeks screening vs 24 weeks follow-up ]

2.  Secondary:   Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score   [ Time Frame: Change from baseline (screening) vs 24 weeks of follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our sample size and treatment durations were somewhat modest to compare severe hypoglycemic episodes and efficacy outcomes before and during treatment.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Van Natta
Organization: Johns Hopkins Data Coordinating Center
phone: 410-614-1362
e-mail: mvannat1@jhu.edu



Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01030341     History of Changes
Other Study ID Numbers: DK-GpCRC-3 GLUMIT-DG
U01DK073983 ( U.S. NIH Grant/Contract )
U01DK073975 ( U.S. NIH Grant/Contract )
U01DK073985 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U01DK074008 ( U.S. NIH Grant/Contract )
U01DK073974 ( U.S. NIH Grant/Contract )
U01DK074007 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2009
First Posted: December 11, 2009
Results First Submitted: April 5, 2017
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018