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| ID | Type | Description | Link |
|---|---|---|---|
| JDRF 22-2011-649 | Other Grant/Funding Number | Juvenile Diabetes Research Foundation |
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| University of Padova | OTHER |
| University of California, Santa Barbara | OTHER |
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An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a hospital based clinical research center.
The principal goal is to validate a smart phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger home-based trials of CTR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Involving Automated CTR | Experimental | Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs)system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct the hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system. |
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| CGM-Augmented Insulin Pump Treatment | No Intervention | Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. Subjects will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. Subjects will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Assistant (DiAs) | Device | A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect size of Control-to-Range (CTR) vs. Continuous Glucose Monitor (CGM)-augmented insulin pump treatment in an outpatient setting. | The investigators expect that compared to CGM-augmented insulin pump treatment, CTR will result in moderate effect size of approximately 0.4, in terms of reduction of the overnight risk for hypoglycemia as measured by the Low Blood Glucose Index computed from retrofitted CGM data. This effect is not expected to be statistically significant with the anticipated sample size but will be used to inform power analysis for the subsequent multi-center trial of CTR at home. | 40 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in target range | CTR will improve (non-significantly at the projected sample size of N=5 subjects/site) the time spent within the target range of 80-140 mg/dL overnight (computed from retrofitted CGM data) and will reduce the extent of postprandial glucose excursions during the day. These data will provide justification and design support for a subsequent larger multi-center trial of CTR at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort with the Diabetes Assistant (DiAs) user interface | 40 hours | |
| Reliability of DiAs remote monitoring | Assess the DiAs remote monitoring by medical personnel/technicians to confirm appropriate functioning outside of the hospital setting. |
Inclusion Criteria:
≥21 and <65 years old.
Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL - confirmed iii. HbA1c ≥6.5% documented - confirmed iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually iii. Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
Use of an insulin pump to treat his/her diabetes for at least 1 year.
Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), target glucose and active insulin.
HbA1c <9% as measured with DCA2000 or equivalent device.
Not currently known to be pregnant, breast feeding, or intending to become pregnant (females).
Demonstration of proper mental status and cognition for the study.
Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving CGM use.
If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Renard, MD, PhD | University of Montpellier Hospital | Principal Investigator |
| Boris P. Kovatchev, PhD | University of Virginia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique CHU Montipellier | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24929429 | Derived | Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, Doyle FJ 3rd. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014 Jul;37(7):1789-96. doi: 10.2337/dc13-2076. Epub 2014 Jun 14. |
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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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|
| 40 hours |
| 40 hours |
| Reliability of inter-device connections between DiAs and the CGM and between DiAs and the insulin pump. | Assess the functioning of the connections between DiAs, the continuous glucose sensor, and the insulin pump. | 40 hours |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |