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Continue Glucose Monitoring Before Insulin Pump

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813421
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jessica Ferris, MD, Children's Hospital Los Angeles

Brief Summary:
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: CGM Informed Not Applicable

Detailed Description:
This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
Study Start Date : March 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: CGM Informed
CGM data was available for use when determining starting insulin pump doses.
Device: CGM Informed
Other Name: iPro2 Professional Continuous Glucose Monitor

No Intervention: Control
CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.



Primary Outcome Measures :
  1. Percentage time within target blood glucose (range: 70-180 mg/dL) [ Time Frame: First 6 weeks of insulin pump therapy ]

Secondary Outcome Measures :
  1. Percentage of time within target blood glucose (range: 70-180 mg/dL) [ Time Frame: First 5 days of insulin pump therapy ]
  2. Mean Blood Glucose (mg/dL) [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    Other measures of glycemic variability obtained by iPro2 download

  3. Blood Glucose Standard Deviation (mg/dL) [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    Other measures of glycemic variability obtained by iPro2 download

  4. Total daily insulin dose (units) [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    Will be obtained by insulin pump download.

  5. Percentage basal insulin (%) [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    Will be obtained by insulin pump download.

  6. Total number of insulin dose adjustments [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    This data will be collected on standardized log sheets.

  7. Total number of phone calls to clinic hotline [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    This data will be collected on standardized log sheets.

  8. Number of insulin dose adjustments made per phone call [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
    This data will be collected on standardized log sheets.

  9. Episodes of hyperglycemia [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
  10. Episodes of hypoglycemia [ Time Frame: First 5 days and first 6 weeks of insulin pump therapy ]
  11. Hemoglobin A1c (%) [ Time Frame: At 6 weeks and 3 months after start of insulin pump therapy ]
  12. Patient/Parent Satisfaction [ Time Frame: At 6 weeks after start of insulin pump therapy ]
    6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy.

  13. Nursing/physician Satisfaction [ Time Frame: Will be collected over 2 weeks, approximately 10 months from initiation of study. ]
    3 question survey addressing usability and feasibility of using CGM data to write insulin pump doses.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and Females aged 2-24 years
  2. Clinical diagnosis of Type 1 diabetes mellitus
  3. Duration of diabetes: At least 6 months

    - This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.

  4. Basal/bolus insulin regimen using long-acting and rapid-acting insulin

    - This will provide a uniform method of insulin therapy.

  5. Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
  6. Willingness to wear the iPro®2 for 5 days continuously per insertion
  7. Participant agrees to comply with the study protocol requirements
  8. Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian

Exclusion Criteria:

  1. Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
  2. Glucocorticoid use within 2 weeks of study enrollment
  3. Concurrent use of other medications that may affect glycemic control
  4. Prior CGM use in the past 6 months
  5. The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
  6. Non-English or non-Spanish speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813421


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Jessica A Ferris, MD Children's Hospital Los Angeles
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Responsible Party: Jessica Ferris, MD, Clinical Fellow, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT02813421    
Other Study ID Numbers: CHLA-15-00535
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jessica Ferris, MD, Children's Hospital Los Angeles:
CGM
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases