Trial Outcomes & Findings for Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes (NCT NCT01939834)

Results Overview

For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

5 consecutive nights

Results posted on

2024-05-21

Participant Flow

Patients with Type 1 Diabetes recruited from medical clinics or local community.

This was a cross-over study in which subjects were assigned to either Overnight Closed-Loop Control (CLC) or Sensor-Augmented Pump Therapy (SAP) sessions first following training sessions. The additional AAA Control portion of the trial was not completed following pilot studies that indicated overnight closed-loop control to be preferable. Therefore the planned N=36 participants were not enrolled and no data was collected in the AAA Control 40hr portion of the trial.

Participant milestones

Participant milestones
Measure	Overnight CLC Control Followed by SAP Participants had an CLC experimental session of 5 consecutive nights of closed loop control which was supervised in an outpatient setting. During the SAP control session, subjects were at home for a week using their home or study insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations.	SAP Followed by Overnight CLC During the SAP control session, subjects were at home for a week using their home or study insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations.Participants had an CLC experimental session of 5 consecutive nights of closed loop control which was supervised in an outpatient setting.
First Phase (Overnight CLC or SAP) STARTED	5	5
First Phase (Overnight CLC or SAP) COMPLETED	5	5
First Phase (Overnight CLC or SAP) NOT COMPLETED	0	0
Second Phase (SAP or Overnight CLC) STARTED	5	5
Second Phase (SAP or Overnight CLC) COMPLETED	5	5
Second Phase (SAP or Overnight CLC) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants: Overnight CLC Control vs CGM + Insulin Pump at Home n=10 Participants Subjects had an Experimental session of 5 consecutive nights of closed loop control which was supervised. During the Control session, subjects will be at home using their home insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations. The active comparator for subjects participating in 5 consecutive nights of closed loop control will be the sensor-augmented pump therapy at home in which the subject will be on their home insulin pump and using a CGM per their usual care.
Age, Continuous	46.4 years STANDARD_DEVIATION 8.5 • n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	2 Participants n=39 Participants
Region of Enrollment United States	5 participants n=39 Participants
Region of Enrollment Italy	5 participants n=39 Participants

PRIMARY outcome

Timeframe: 5 consecutive nights

Population: Cross-over trial with 10 participants total.

For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.

Outcome measures

Outcome measures
Measure	Overnight Closed-Loop Control (CLC) n=10 Participants Participants had an CLC experimental session of 5 consecutive nights of closed loop control (23:00 to 07:00) which was supervised in an outpatient setting.	Sensor Augmented Pump Therapy (SAP) n=10 Participants During the SAP control session, subjects were at home for a week using their home or study insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations.
Time in Range Overnight	54.5 % time in range Interval 36.5 to 74.7	32.2 % time in range Interval 7.8 to 54.7

SECONDARY outcome

Timeframe: 5 consecutive nights

A secondary goal of the cross-over trial is to evaluate the ability of the CLC to prevent hypoglycemia with the outcome measure of Low Blood Glucose Index. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk (there is no maximum score). Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale. The calculation of LBGI uses all available CGM values during the 5 consecutive nights of study to create one index. For the SAP group, the mean value lies outside the interquartile range due to outlying values that contribute to increasing the mean.

Outcome measures

Outcome measures
Measure	Overnight Closed-Loop Control (CLC) n=10 Participants Participants had an CLC experimental session of 5 consecutive nights of closed loop control (23:00 to 07:00) which was supervised in an outpatient setting.	Sensor Augmented Pump Therapy (SAP) n=10 Participants During the SAP control session, subjects were at home for a week using their home or study insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations.
Evaluating the Risk for Hypoglycemia as Measured by the Low Blood Glucose Index	0.65 index score Interval 0.02 to 0.84	1.05 index score Interval 0.0 to 0.96

SECONDARY outcome

Timeframe: 5 consecutive nights

Closed loop control will improve the time spent within the target range of 70-180 mg/dl (computed from retrofitted CGM data).

Outcome measures

Outcome measures
Measure	Overnight Closed-Loop Control (CLC) n=10 Participants Participants had an CLC experimental session of 5 consecutive nights of closed loop control (23:00 to 07:00) which was supervised in an outpatient setting.	Sensor Augmented Pump Therapy (SAP) n=10 Participants During the SAP control session, subjects were at home for a week using their home or study insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations.
Time Within Target Range	85.4 % time in range Interval 71.6 to 100.0	59.1 % time in range Interval 30.2 to 100.0

Adverse Events

Overnight CLC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sensor-Augmented Pump Therapy (SAP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sue Brown

University of Virginia

Phone: 434-924-1825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place