Trial Outcomes & Findings for New Patient Support Program in Type 2 Diabetes (NCT NCT03752567)

Results Overview

Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of "pharmacy of service".

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

12 months

Results posted on

2020-02-12

Participant Flow

Enrollment took place in the first 15 days of the operating period (November 1, 2018 - October 31, 2019). The patients were enrolled at the only experimentation center represented by La Regina pharmacy, a community pharmacy in a small rural center in southern Italy.

None of the enrolled patients were excluded from the ongoing trial. All patients completed the entire observation period.

Participant milestones

Participant milestones
Measure	Group Study Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria). Follow up: like group descriptions
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Patient Support Program in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Study n=40 Participants Enrolled patients include people with reduced glucose tolerance, or impaired fasting blood sugar, or type 2 diabetes free of organ complications, or type 2 diabetes with chronic complications.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Age, Continuous	64.5 years STANDARD_DEVIATION 9.52 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of "pharmacy of service".

Outcome measures

Outcome measures
Measure	Group Study n=40 Participants The patients enrolled were 40. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance * impaired fasting blood sugar * type 2 diabetes free of organ complications * type 2 diabetes with chronic complications
Percent of Participants With Adherence to the PDTA Percentage of adherence to PDTA - 3 months	98 percentage of participants
Percent of Participants With Adherence to the PDTA Percentage of adherence to PDTA - 6 months	98 percentage of participants
Percent of Participants With Adherence to the PDTA Percentage of adherence to PDTA - 12 months	98 percentage of participants

SECONDARY outcome

Timeframe: 365 days

variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)

Outcome measures

Outcome measures
Measure	Group Study n=40 Participants The patients enrolled were 40. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance * impaired fasting blood sugar * type 2 diabetes free of organ complications * type 2 diabetes with chronic complications
Waiting Time Electrocardiogram waiting list	117 days Standard Deviation 57.5
Waiting Time Fundus Oculi waiting list	120 days Standard Deviation 50

SECONDARY outcome

Timeframe: 12 months

variation of arterial pressure (Systolic, Diastolic) (mmHg)

Outcome measures

Outcome measures
Measure	Group Study n=40 Participants The patients enrolled were 40. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance * impaired fasting blood sugar * type 2 diabetes free of organ complications * type 2 diabetes with chronic complications
Levels of Arterial Pressure Systolic pressure variation	-13 percentage of change Standard Deviation 12
Levels of Arterial Pressure Diastolic pressure variation	-9 percentage of change Standard Deviation 16

SECONDARY outcome

Timeframe: 12 months

variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy

Outcome measures

Outcome measures
Measure	Group Study n=40 Participants The patients enrolled were 40. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance * impaired fasting blood sugar * type 2 diabetes free of organ complications * type 2 diabetes with chronic complications
Levels of HbA1c	-4 percentage of change Standard Deviation 16

SECONDARY outcome

Timeframe: 12 months

variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy

Outcome measures

Outcome measures
Measure	Group Study n=40 Participants The patients enrolled were 40. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance * impaired fasting blood sugar * type 2 diabetes free of organ complications * type 2 diabetes with chronic complications
Levels of LDL-cholesterol	-10 percentage of variation Standard Deviation 27

SECONDARY outcome

Timeframe: 12 months

Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the "pharmacy of service" (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)

Outcome measures

Outcome measures
Measure	Group Study n=40 Participants The patients enrolled were 40. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance * impaired fasting blood sugar * type 2 diabetes free of organ complications * type 2 diabetes with chronic complications
Economic Impact	210.25 euro/patient/year Standard Deviation 80.25

Adverse Events

Group Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group Study n=40 participants at risk The 40 patients enrolled were 50% men and 50% women. The average age was 64.5 years. The median of the comorbidities presented by the participants was two, and in 33% (n = 13) of the cases there were more than 2 comorbidities per patient. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance 15% * impaired fasting blood sugar 5% * type 2 diabetes free of organ complications 38% * type 2 diabetes with chronic complications 42%
Cardiac disorders Description	0.00% 0/40 • 12 months There wasn't any risk of adverse event.

Other adverse events

Other adverse events
Measure	Group Study n=40 participants at risk The 40 patients enrolled were 50% men and 50% women. The average age was 64.5 years. The median of the comorbidities presented by the participants was two, and in 33% (n = 13) of the cases there were more than 2 comorbidities per patient. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance 15% * impaired fasting blood sugar 5% * type 2 diabetes free of organ complications 38% * type 2 diabetes with chronic complications 42%
Cardiac disorders Not Serious Adverse Event	0.00% 0/40 • 12 months There wasn't any risk of adverse event.

Additional Information

Dr. Raffaele La Regina

Farmacia La Regina

Phone: +393389066138

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place