Type 1 Diabetes Mellitus
Conditions
Keywords
Closed Loop Insulin Delivery, Diabetes, Type 1 Diabetes, Artificial pancreas
Brief summary
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.
Detailed description
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.
Interventions
DEVICEClosed-loop Insulin Pump therapy
Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
DEVICEStandard Insulin Pump Therapy
Subjects insulin doses followed their usual home routine.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No
Inclusion criteria
* Age \< 7 years old * Type 1 Diabetes (as diagnosed by outpatient endocrinologist) with duration greater than 6 months * Treated with insulin pump therapy for greater than 6 weeks
Exclusion criteria
* Any other chronic medical condition * Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Glycemic Control | Participants will be followed for the duration of the 48 hour protocol. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial Glycemic Control | Participants will be followed for the duration of the 48 hour protocol | Peak post-prandial blood sugar between 8 AM and noon |
| Number of Interventions for Hypoglycemia | Participants will be followed for the duration of the 48 hour protocol | The number of interventions for hypoglycemia between 10 PM - 8 AM. |
| Pre-lunch Blood Glucose Level | Participants will be followed for the duration of the 48 hour protocol | Blood glucose levels were documented at 12 pm just prior to being served lunch. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 6 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Insulin Pump Therapy First | Closed-Loop Insulin Therapy First | Total |
|---|---|---|---|
| Age, Continuous age | 3.7 years STANDARD_DEVIATION 1.3 | 5.5 years STANDARD_DEVIATION 0.9 | 5.1 years STANDARD_DEVIATION 1.4 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Participants will be followed for the duration of the 48 hour protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Insulin Pump Therapy | Nocturnal Glycemic Control | 3.2 Hours | Standard Error 0.77 |
| Closed-Loop Insulin Therapy | Nocturnal Glycemic Control | 5.3 Hours | Standard Error 0.66 |
Comparison: We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)p-value: 0.12t-test, 2 sided
Secondary
Number of Interventions for Hypoglycemia
The number of interventions for hypoglycemia between 10 PM - 8 AM.
Time frame: Participants will be followed for the duration of the 48 hour protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Insulin Pump Therapy | Number of Interventions for Hypoglycemia | 4 Interventions |
| Closed-Loop Insulin Therapy | Number of Interventions for Hypoglycemia | 5 Interventions |
Secondary
Post-prandial Glycemic Control
Peak post-prandial blood sugar between 8 AM and noon
Time frame: Participants will be followed for the duration of the 48 hour protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Insulin Pump Therapy | Post-prandial Glycemic Control | 353 mg/dL | Standard Error 24 |
| Closed-Loop Insulin Therapy | Post-prandial Glycemic Control | 367 mg/dL | Standard Error 23 |
Secondary
Pre-lunch Blood Glucose Level
Blood glucose levels were documented at 12 pm just prior to being served lunch.
Time frame: Participants will be followed for the duration of the 48 hour protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Insulin Pump Therapy | Pre-lunch Blood Glucose Level | 273 mg/dL | Standard Error 24 |
| Closed-Loop Insulin Therapy | Pre-lunch Blood Glucose Level | 189 mg/dL | Standard Error 18 |