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The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. The standard treatment is to give insulin either by shots or using an insulin pump. A new device, called closed-loop insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a computer. The CGM will send the sugar levels to a computer which automatically figures out how much insulin to give and then gives that amount of insulin through the insulin pump. It will give the child insulin to bring sugar levels down if they are high, and will give less insulin if the child's blood sugar is getting lower. Earlier research using closed-loop insulin therapy has shown the ability for it to improve diabetes care in adults and older children, but there has been no research of closed-loop insulin therapy in young children. This study will compare children's current insulin therapy with the closed-loop system. The knowledge that the investigators gain from this research will help us to figure out whether closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes care.
We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient clinical research center for 48 hours. They will receive their standard home insulin therapy for one day and semi-closed-loop insulin therapy for the other day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Insulin Pump Therapy first, then Closed Loop | Active Comparator | Standard therapy day 1, Closed-Loop therapy day 2. |
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| Closed Loop first, then Standard Insulin Pump Therapy | Active Comparator | Closed-loop therapy day 1, standard therapy day 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop Insulin Pump therapy | Device | Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon. |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Glycemic Control | Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group. | Participants will be followed for the duration of the 48 hour protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial Glycemic Control | Peak post-prandial blood sugar between 8 AM and noon | Participants will be followed for the duration of the 48 hour protocol |
| Number of Interventions for Hypoglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Dauber, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23033237 | Result | Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care. 2013 Feb;36(2):222-7. doi: 10.2337/dc12-1079. Epub 2012 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Insulin Pump Therapy First | The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2. Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon. Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol. |
| FG001 | Closed-Loop Insulin Therapy First | The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2. Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon. Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Insulin Pump Therapy First | The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2. Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon. Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nocturnal Glycemic Control | Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group. | Posted | Mean | Standard Error | Hours | Participants will be followed for the duration of the 48 hour protocol. |
|
Participants will be followed for the duration of the 48 hour protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Insulin Pump Therapy | Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication Error | Metabolism and nutrition disorders | Systematic Assessment | One episode where mealtime insulin was not administered due to a nursing error. The patient was transiently hyperglycemic until an additional dose of insulin was given. This was a minor event but was unexpected. No harm came to the patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garry Steil (Assistant Prof. of Pediatrics) | Boston Children's Hospital | 617-355-7504 | garry.steil@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Standard Insulin Pump Therapy | Device | Subjects insulin doses followed their usual home routine. |
|
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The number of interventions for hypoglycemia between 10 PM - 8 AM.
| Participants will be followed for the duration of the 48 hour protocol |
| Pre-lunch Blood Glucose Level | Blood glucose levels were documented at 12 pm just prior to being served lunch. | Participants will be followed for the duration of the 48 hour protocol |
| BG001 | Closed-Loop Insulin Therapy First | The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2. Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon. Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Post-prandial Glycemic Control | Peak post-prandial blood sugar between 8 AM and noon | Posted | Mean | Standard Error | mg/dL | Participants will be followed for the duration of the 48 hour protocol |
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| Secondary | Number of Interventions for Hypoglycemia | The number of interventions for hypoglycemia between 10 PM - 8 AM. | Posted | Number | Interventions | Participants will be followed for the duration of the 48 hour protocol |
|
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| Secondary | Pre-lunch Blood Glucose Level | Blood glucose levels were documented at 12 pm just prior to being served lunch. | Posted | Mean | Standard Error | mg/dL | Participants will be followed for the duration of the 48 hour protocol |
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| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Closed-Loop Insulin Therapy | Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2. | 0 | 10 | 0 | 10 |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |