Clinical trial NCT02813421: Continue Glucose Monitoring Before Insulin Pump
Official title: Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: CGM
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)
timeFrame: First 6 weeks of insulin pump therapy
Secondary outcomes:
measure: Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)
timeFrame: First 5 days of insulin pump therapy
measure: Mean Blood Glucose (mg/dL)
timeFrame: First 6 weeks of insulin pump therapy
measure: Percentage Time Hyperglycemic
timeFrame: First 6 weeks of insulin pump therapy
measure: Total Daily Insulin Dose (Units)
timeFrame: First 6 weeks of insulin pump therapy
measure: Percentage Basal Insulin (%)
timeFrame: First 6 weeks of insulin pump therapy
measure: Total Number of Insulin Dose Adjustments
timeFrame: First 6 weeks of insulin pump therapy
measure: Total Number of Phone Calls to Clinic Hotline
timeFrame: First 6 weeks of insulin pump therapy
measure: Number of Insulin Dose Adjustments Made Per Phone Call
timeFrame: First 6 weeks of insulin pump therapy
measure: Episodes of DKA
timeFrame: First 6 weeks of insulin pump therapy
measure: Total Number of Episodes of Severe Hypoglycemia
timeFrame: First 6 weeks of insulin pump therapy
measure: Hemoglobin A1c (%)
timeFrame: Baseline to 3 months post-pump start
measure: Number of Participants With Satisfaction of Transition to Pump Therapy
timeFrame: At 6 weeks after start of insulin pump therapy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jessica A Ferris, MD
role: PRINCIPAL_INVESTIGATOR
References: