Trial Outcomes & Findings for Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes (NCT NCT03557892)

Results Overview

Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

4 months

Results posted on

2022-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Subcutaneous Insulin Infusion+Continuous Glucose Monitoring (CSII+CGM) CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM	Multiple Daily Injections Regimen (MDI) With Degludec MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CSII+CGM n=14 Participants CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM	MDI With Degludec n=14 Participants MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin	Total n=28 Participants Total of all reporting groups
Age, Continuous	44 years n=14 Participants	41 years n=14 Participants	42 years n=28 Participants
Sex: Female, Male Female	6 Participants n=14 Participants	6 Participants n=14 Participants	12 Participants n=28 Participants
Sex: Female, Male Male	8 Participants n=14 Participants	8 Participants n=14 Participants	16 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
HbA1c	61 mmol/mol STANDARD_DEVIATION 4 • n=14 Participants	62 mmol/mol STANDARD_DEVIATION 5 • n=14 Participants	61 mmol/mol STANDARD_DEVIATION 5 • n=28 Participants

PRIMARY outcome

Timeframe: 4 months

Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)

Outcome measures

Outcome measures
Measure	CSII+CGM n=14 Participants CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM	MDI With Degludec n=14 Participants MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
HbA1c	-6.1 mmol/mol Standard Deviation 4.0	0.5 mmol/mol Standard Deviation 4.5

SECONDARY outcome

Timeframe: 4 months

Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase

Outcome measures

Outcome measures
Measure	CSII+CGM n=14 Participants CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM	MDI With Degludec n=14 Participants MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Severe Hypoglycemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months

Number of participants with local reactions at infusion/glucose monitoring site

Outcome measures

Outcome measures
Measure	CSII+CGM n=14 Participants CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM	MDI With Degludec n=14 Participants MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Local Reactions	8 Participants	0 Participants

Adverse Events

CSII+CGM

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

MDI With Degludec

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CSII+CGM n=14 participants at risk CGM+CSII: Animas Vibe Platinum insulin pump and Dexcom G4 CGM	MDI With Degludec n=14 participants at risk MDI with degludec: Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Skin and subcutaneous tissue disorders Local skin reactions	57.1% 8/14 • Number of events 8 • 4 months for each treatment arm	0.00% 0/14 • 4 months for each treatment arm

Additional Information

Dr Ilaria Dicembrini

University of Florence Medical School and AOU Careggi

Phone: +393387861041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place