Continue Glucose Monitoring Before Insulin Pump

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813421
• Other study ID #: CHLA-15-00535
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2021
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• CGM Informed

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)		First 6 weeks of insulin pump therapy
Secondary	Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)		First 5 days of insulin pump therapy
Secondary	Mean Blood Glucose (mg/dL)	Other measures of glycemic variability obtained by iPro2 download	First 6 weeks of insulin pump therapy
Secondary	Percentage Time Hyperglycemic	Data obtained by iPro2 download	First 6 weeks of insulin pump therapy
Secondary	Total Daily Insulin Dose (Units)	Will be obtained by insulin pump download.	First 6 weeks of insulin pump therapy
Secondary	Percentage Basal Insulin (%)	Will be obtained by insulin pump download.	First 6 weeks of insulin pump therapy
Secondary	Total Number of Insulin Dose Adjustments	This data will be collected on standardized log sheets.	First 6 weeks of insulin pump therapy
Secondary	Total Number of Phone Calls to Clinic Hotline	This data will be collected on standardized log sheets.	First 6 weeks of insulin pump therapy
Secondary	Number of Insulin Dose Adjustments Made Per Phone Call	This data will be collected on standardized log sheets.	First 6 weeks of insulin pump therapy
Secondary	Episodes of DKA		First 6 weeks of insulin pump therapy
Secondary	Total Number of Episodes of Severe Hypoglycemia		First 6 weeks of insulin pump therapy
Secondary	Hemoglobin A1c (%)	Difference in HbA1c from baseline to 3 months post-pump start	Baseline to 3 months post-pump start
Secondary	Number of Participants With Satisfaction of Transition to Pump Therapy	6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy.	At 6 weeks after start of insulin pump therapy