Table 2. Open in new tab Recent...

Device

Study

Purpose(s)

Sample size

Diabetes type

Interval time study

Population targeted

Principal outcomes

Conclusion

Ref.

Automated insulin delivery systems

Randomized controlled trial

To evaluate long-term safety and effectiveness of open-source AID
Comparing open-source AID with SAPT

N = 94

T1D

24 weeks

Children and adults with T1D (7-70 years)

Mean TIR (3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT
TIR was 56.9% with SAPT and 69.1% with AID
The treatment impact did not differ by age or insulin pump type
HbA1c was lower with AID

The system is both effective and safe, regardless of the insulin pump used
Using the AID system led to sustained improvements in BG control

(43)

Automated insulin delivery systems

Observational Study

Evaluating the effectiveness of initiating first-generation AID systems for the management of T1D over a period of up to 2 years

N = 94

T1D

6-24 months

Adults with T1D, between 2019 and 2021, were observed

HbA1c decreased by mean 0.5%
CGM time in range 3.9-10.0 mmol/L increased by 11%

The introduction of real-world AID systems led to early improvements in glucose control

(44)

Automated insulin delivery systems

Randomized controlled trial

To evaluate the clinical efficacy AID T1D pregnancy

N = 124

T1D

From 16 weeks’ gestation until delivery

Pregnant Women with T1D

The proportion of time that maternal GLs were within the target range was higher during the use of AID than standard insulin therapy (10%)
Participants randomized to AID had larger improvement in hyperglycemia (AID vs control −11%) and lower HbA1c (−0.34%)

The use of AID significantly enhanced maternal BG control throughout the duration of the pregnancy in individuals with T1D

(45)

Automated insulin delivery systems

Randomized controlled trial

The evaluation of the effectiveness and safety of fully AID systems in comparison to conventional insulin therapy

N = 17

T2D

—

Patients with T2D suffering hemodialysis

Compared with control patients receiving standard subcutaneous insulin therapy, patients receiving AID
Their CGM readings were within the target range of 5.6-10.0 mmol/L

AID provides a novel approach to achieve effective and safe glucose control in this vulnerable patient population

(46)

Automated insulin delivery systems

Randomized controlled trial

Comparing FCL AID with standard insulin therapy in adults with T2D

N = 26

T2D

Two 8-week periods

Adults with T2D

Proportion of time in target glucose range was 66.3% with FCL therapy vs 32.3% with CT
Mean GL was lower during the FCL therapy period than during the CT period;
HbA1c was lower following FCL therapy than following CT

This method could potentially be considered a safe and effective approach in enhancing outcomes of T2D patients

(47)

Smart connected insulin pen

Observational study

The examination of the impact of the connected NovoPen 6 on insulin regimen management and glycemic control in individuals with T1D

N = 94

T1D

24 months

People with T1D

TIR showed a significant increase from the baseline period to the follow-up period
Over the course of the study, the mean daily MBD of injections decreased by 43%

This study underscores the potential advantages in glycemic management and insulin dosing practices when reliable insulin dose data from a connected insulin pen

(40)

Connected insulin pen

Clinical trial

Using connected pen device to assess the frequency of MBD during periods of masked and unmasked CGM

N = 64

T1D and T2D

12 weeks

People with T1D and people with T2D

MBD, %TAR, %TBR, and HbA1c reduced significantly (0.74 MBD/day to 0.62 MBD/day)
%TIR increased significantly (41.9%-49.0%

Tailored therapeutic approaches may be needed for individuals with T1D and T2D to address the impact of MBD on glycemic control

(49)

Sensor-integrated pump

Randomized controlled trial

Examining the effectiveness of the MiniMed 640G insulin pump, which is equipped with the SmartGuard predictive low-glucose management (PLGM) feature

—

T1D

24 weeks

Adults (age 24-75 years) with T1D

The mean number of hypoglycemic events, defined as sensor glucose ≤55 mg/dL for >20 consecutive minutes
Various glycemic indices, glycated hemoglobin levels, and patient-reported outcomes such as hypoglycemia awareness and treatment satisfaction

The SMILE study is expected to offer valuable insights into the efficacy of SmartGuard technology in managing T1D patients

(48)

Device

Study

Purpose(s)

Sample size

Diabetes type

Interval time study

Population targeted

Principal outcomes

Conclusion

Ref.

Automated insulin delivery systems

Randomized controlled trial

To evaluate long-term safety and effectiveness of open-source AID
Comparing open-source AID with SAPT

N = 94

T1D

24 weeks

Children and adults with T1D (7-70 years)

Mean TIR (3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT
TIR was 56.9% with SAPT and 69.1% with AID
The treatment impact did not differ by age or insulin pump type
HbA1c was lower with AID

The system is both effective and safe, regardless of the insulin pump used
Using the AID system led to sustained improvements in BG control

(43)

Automated insulin delivery systems

Observational Study

Evaluating the effectiveness of initiating first-generation AID systems for the management of T1D over a period of up to 2 years

N = 94

T1D

6-24 months

Adults with T1D, between 2019 and 2021, were observed

HbA1c decreased by mean 0.5%
CGM time in range 3.9-10.0 mmol/L increased by 11%

The introduction of real-world AID systems led to early improvements in glucose control

(44)

Automated insulin delivery systems

Randomized controlled trial

To evaluate the clinical efficacy AID T1D pregnancy

N = 124

T1D

From 16 weeks’ gestation until delivery

Pregnant Women with T1D

The proportion of time that maternal GLs were within the target range was higher during the use of AID than standard insulin therapy (10%)
Participants randomized to AID had larger improvement in hyperglycemia (AID vs control −11%) and lower HbA1c (−0.34%)

The use of AID significantly enhanced maternal BG control throughout the duration of the pregnancy in individuals with T1D

(45)

Automated insulin delivery systems

Randomized controlled trial

The evaluation of the effectiveness and safety of fully AID systems in comparison to conventional insulin therapy

N = 17

T2D

—

Patients with T2D suffering hemodialysis

Compared with control patients receiving standard subcutaneous insulin therapy, patients receiving AID
Their CGM readings were within the target range of 5.6-10.0 mmol/L

AID provides a novel approach to achieve effective and safe glucose control in this vulnerable patient population

(46)

Automated insulin delivery systems

Randomized controlled trial

Comparing FCL AID with standard insulin therapy in adults with T2D

N = 26

T2D

Two 8-week periods

Adults with T2D

Proportion of time in target glucose range was 66.3% with FCL therapy vs 32.3% with CT
Mean GL was lower during the FCL therapy period than during the CT period;
HbA1c was lower following FCL therapy than following CT

This method could potentially be considered a safe and effective approach in enhancing outcomes of T2D patients

(47)

Smart connected insulin pen

Observational study

The examination of the impact of the connected NovoPen 6 on insulin regimen management and glycemic control in individuals with T1D

N = 94

T1D

24 months

People with T1D

TIR showed a significant increase from the baseline period to the follow-up period
Over the course of the study, the mean daily MBD of injections decreased by 43%

This study underscores the potential advantages in glycemic management and insulin dosing practices when reliable insulin dose data from a connected insulin pen

(40)

Connected insulin pen

Clinical trial

Using connected pen device to assess the frequency of MBD during periods of masked and unmasked CGM

N = 64

T1D and T2D

12 weeks

People with T1D and people with T2D

MBD, %TAR, %TBR, and HbA1c reduced significantly (0.74 MBD/day to 0.62 MBD/day)
%TIR increased significantly (41.9%-49.0%

Tailored therapeutic approaches may be needed for individuals with T1D and T2D to address the impact of MBD on glycemic control

(49)

Sensor-integrated pump

Randomized controlled trial

Examining the effectiveness of the MiniMed 640G insulin pump, which is equipped with the SmartGuard predictive low-glucose management (PLGM) feature

—

T1D

24 weeks

Adults (age 24-75 years) with T1D

The mean number of hypoglycemic events, defined as sensor glucose ≤55 mg/dL for >20 consecutive minutes
Various glycemic indices, glycated hemoglobin levels, and patient-reported outcomes such as hypoglycemia awareness and treatment satisfaction

The SMILE study is expected to offer valuable insights into the efficacy of SmartGuard technology in managing T1D patients

(48)

Table 2.

Open in new tab

Recent randomized trials, clinical trials, and observational studies (conducted between 2018 and 2024) focused on technologies associated with insulin delivery systems, including insulin pumps and connected insulin pens

Device	Study	Purpose(s)	Sample size	Diabetes type	Interval time study	Population targeted	Principal outcomes	Conclusion	Ref.
Automated insulin delivery systems	Randomized controlled trial	To evaluate long-term safety and effectiveness of open-source AID Comparing open-source AID with SAPT	N = 94	T1D	24 weeks	Children and adults with T1D (7-70 years)	Mean TIR (3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT TIR was 56.9% with SAPT and 69.1% with AID The treatment impact did not differ by age or insulin pump type HbA1c was lower with AID	The system is both effective and safe, regardless of the insulin pump used Using the AID system led to sustained improvements in BG control	(43)
Automated insulin delivery systems	Observational Study	Evaluating the effectiveness of initiating first-generation AID systems for the management of T1D over a period of up to 2 years	N = 94	T1D	6-24 months	Adults with T1D, between 2019 and 2021, were observed	HbA1c decreased by mean 0.5% CGM time in range 3.9-10.0 mmol/L increased by 11%	The introduction of real-world AID systems led to early improvements in glucose control	(44)
Automated insulin delivery systems	Randomized controlled trial	To evaluate the clinical efficacy AID T1D pregnancy	N = 124	T1D	From 16 weeks’ gestation until delivery	Pregnant Women with T1D	The proportion of time that maternal GLs were within the target range was higher during the use of AID than standard insulin therapy (10%) Participants randomized to AID had larger improvement in hyperglycemia (AID vs control −11%) and lower HbA1c (−0.34%)	The use of AID significantly enhanced maternal BG control throughout the duration of the pregnancy in individuals with T1D	(45)
Automated insulin delivery systems	Randomized controlled trial	The evaluation of the effectiveness and safety of fully AID systems in comparison to conventional insulin therapy	N = 17	T2D	—	Patients with T2D suffering hemodialysis	Compared with control patients receiving standard subcutaneous insulin therapy, patients receiving AID Their CGM readings were within the target range of 5.6-10.0 mmol/L	AID provides a novel approach to achieve effective and safe glucose control in this vulnerable patient population	(46)
Automated insulin delivery systems	Randomized controlled trial	Comparing FCL AID with standard insulin therapy in adults with T2D	N = 26	T2D	Two 8-week periods	Adults with T2D	Proportion of time in target glucose range was 66.3% with FCL therapy vs 32.3% with CT Mean GL was lower during the FCL therapy period than during the CT period; HbA1c was lower following FCL therapy than following CT	This method could potentially be considered a safe and effective approach in enhancing outcomes of T2D patients	(47)
Smart connected insulin pen	Observational study	The examination of the impact of the connected NovoPen 6 on insulin regimen management and glycemic control in individuals with T1D	N = 94	T1D	24 months	People with T1D	TIR showed a significant increase from the baseline period to the follow-up period Over the course of the study, the mean daily MBD of injections decreased by 43%	This study underscores the potential advantages in glycemic management and insulin dosing practices when reliable insulin dose data from a connected insulin pen	(40)
Connected insulin pen	Clinical trial	Using connected pen device to assess the frequency of MBD during periods of masked and unmasked CGM	N = 64	T1D and T2D	12 weeks	People with T1D and people with T2D	MBD, %TAR, %TBR, and HbA1c reduced significantly (0.74 MBD/day to 0.62 MBD/day) %TIR increased significantly (41.9%-49.0%	Tailored therapeutic approaches may be needed for individuals with T1D and T2D to address the impact of MBD on glycemic control	(49)
Sensor-integrated pump	Randomized controlled trial	Examining the effectiveness of the MiniMed 640G insulin pump, which is equipped with the SmartGuard predictive low-glucose management (PLGM) feature	—	T1D	24 weeks	Adults (age 24-75 years) with T1D	The mean number of hypoglycemic events, defined as sensor glucose ≤55 mg/dL for >20 consecutive minutes Various glycemic indices, glycated hemoglobin levels, and patient-reported outcomes such as hypoglycemia awareness and treatment satisfaction	The SMILE study is expected to offer valuable insights into the efficacy of SmartGuard technology in managing T1D patients	(48)

Device	Study	Purpose(s)	Sample size	Diabetes type	Interval time study	Population targeted	Principal outcomes	Conclusion	Ref.
Automated insulin delivery systems	Randomized controlled trial	To evaluate long-term safety and effectiveness of open-source AID Comparing open-source AID with SAPT	N = 94	T1D	24 weeks	Children and adults with T1D (7-70 years)	Mean TIR (3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT TIR was 56.9% with SAPT and 69.1% with AID The treatment impact did not differ by age or insulin pump type HbA1c was lower with AID	The system is both effective and safe, regardless of the insulin pump used Using the AID system led to sustained improvements in BG control	(43)
Automated insulin delivery systems	Observational Study	Evaluating the effectiveness of initiating first-generation AID systems for the management of T1D over a period of up to 2 years	N = 94	T1D	6-24 months	Adults with T1D, between 2019 and 2021, were observed	HbA1c decreased by mean 0.5% CGM time in range 3.9-10.0 mmol/L increased by 11%	The introduction of real-world AID systems led to early improvements in glucose control	(44)
Automated insulin delivery systems	Randomized controlled trial	To evaluate the clinical efficacy AID T1D pregnancy	N = 124	T1D	From 16 weeks’ gestation until delivery	Pregnant Women with T1D	The proportion of time that maternal GLs were within the target range was higher during the use of AID than standard insulin therapy (10%) Participants randomized to AID had larger improvement in hyperglycemia (AID vs control −11%) and lower HbA1c (−0.34%)	The use of AID significantly enhanced maternal BG control throughout the duration of the pregnancy in individuals with T1D	(45)
Automated insulin delivery systems	Randomized controlled trial	The evaluation of the effectiveness and safety of fully AID systems in comparison to conventional insulin therapy	N = 17	T2D	—	Patients with T2D suffering hemodialysis	Compared with control patients receiving standard subcutaneous insulin therapy, patients receiving AID Their CGM readings were within the target range of 5.6-10.0 mmol/L	AID provides a novel approach to achieve effective and safe glucose control in this vulnerable patient population	(46)
Automated insulin delivery systems	Randomized controlled trial	Comparing FCL AID with standard insulin therapy in adults with T2D	N = 26	T2D	Two 8-week periods	Adults with T2D	Proportion of time in target glucose range was 66.3% with FCL therapy vs 32.3% with CT Mean GL was lower during the FCL therapy period than during the CT period; HbA1c was lower following FCL therapy than following CT	This method could potentially be considered a safe and effective approach in enhancing outcomes of T2D patients	(47)
Smart connected insulin pen	Observational study	The examination of the impact of the connected NovoPen 6 on insulin regimen management and glycemic control in individuals with T1D	N = 94	T1D	24 months	People with T1D	TIR showed a significant increase from the baseline period to the follow-up period Over the course of the study, the mean daily MBD of injections decreased by 43%	This study underscores the potential advantages in glycemic management and insulin dosing practices when reliable insulin dose data from a connected insulin pen	(40)
Connected insulin pen	Clinical trial	Using connected pen device to assess the frequency of MBD during periods of masked and unmasked CGM	N = 64	T1D and T2D	12 weeks	People with T1D and people with T2D	MBD, %TAR, %TBR, and HbA1c reduced significantly (0.74 MBD/day to 0.62 MBD/day) %TIR increased significantly (41.9%-49.0%	Tailored therapeutic approaches may be needed for individuals with T1D and T2D to address the impact of MBD on glycemic control	(49)
Sensor-integrated pump	Randomized controlled trial	Examining the effectiveness of the MiniMed 640G insulin pump, which is equipped with the SmartGuard predictive low-glucose management (PLGM) feature	—	T1D	24 weeks	Adults (age 24-75 years) with T1D	The mean number of hypoglycemic events, defined as sensor glucose ≤55 mg/dL for >20 consecutive minutes Various glycemic indices, glycated hemoglobin levels, and patient-reported outcomes such as hypoglycemia awareness and treatment satisfaction	The SMILE study is expected to offer valuable insights into the efficacy of SmartGuard technology in managing T1D patients	(48)

Abbreviations: AID, automated insulin delivery; BG, blood glucose; CGM, continuous glucose monitoring; CT, control therapy; FCL, fully closed-loop; GL, glucose level; MBD, missed bolus doses; SAPT, sensor-augmented pump therapy; T1D, type 1 diabetes; T2D, type2 diabetes; TAR, time above range; TIR, time in range.

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