Trial Outcomes & Findings for Telemedicine Strategy With Home Treatment Save Resources (NCT NCT02214017)

NCT ID: NCT02214017

Last Updated: 2018-11-19

Results Overview

Percent of glycosylated hemoglobin, HbA1c

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Six months of treatment
• Results posted on: 2018-11-19

Participant Flow

Participant milestones

Measure	Standard Care Diabetic patients attended usual procedure in the outpatient clinic with regular visits Behavioral motivation: Optimization of medical care in diabetes	Telemedicine Group After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC. A videotelephone, TandBerg E20, Behavioral motivation: Optimization of medical care in diabetes
Overall Study STARTED	22	18
Overall Study COMPLETED	22	18
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

Measure	Standard Care n=22 Participants Diabetic patients attended usual procedure in the outpatient clinic with regular visits Behavioral motivation: Optimization of medical care in diabetes	Telemedicine Group n=18 Participants After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC. A videotelephone, TandBerg E20, Behavioral motivation: Optimization of medical care in diabetes	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=22 Participants	0 Participants n=18 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=22 Participants	12 Participants n=18 Participants	21 Participants n=40 Participants
Age, Categorical >=65 years	13 Participants n=22 Participants	6 Participants n=18 Participants	19 Participants n=40 Participants
Age, Continuous	68 years n=22 Participants	59 years n=18 Participants	64 years n=40 Participants
Sex: Female, Male Female	8 Participants n=22 Participants	5 Participants n=18 Participants	13 Participants n=40 Participants
Sex: Female, Male Male	14 Participants n=22 Participants	13 Participants n=18 Participants	27 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Denmark	22 participants n=22 Participants	18 participants n=18 Participants	40 participants n=40 Participants
BMI	30 kg / m^2 n=22 Participants	32.7 kg / m^2 n=18 Participants	31.8 kg / m^2 n=40 Participants
duration of type 2 diabetes	9.5 years n=22 Participants	11.5 years n=18 Participants	11 years n=40 Participants
insulin treatment	7 Participants n=22 Participants	8 Participants n=18 Participants	15 Participants n=40 Participants

PRIMARY outcome

Timeframe: Six months of treatment

Percent of glycosylated hemoglobin, HbA1c

Outcome measures

Measure	Standard Care n=22 Participants Diabetic patients attended usual procedure in the outpatient clinic with regular visits Behavioral motivation: Optimization of medical care in diabetes	Telemedicine Group n=18 Participants After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC. A videotelephone, TandBerg E20, Behavioral motivation: Optimization of medical care in diabetes
Glycemia	7.1 percent of glycosylated hemoglobin Interval 5.8 to 9.6	7.6 percent of glycosylated hemoglobin Interval 6.2 to 11.9

SECONDARY outcome

Timeframe: Six months of treatment

Total-cholesterol

Outcome measures

Measure	Standard Care n=22 Participants Diabetic patients attended usual procedure in the outpatient clinic with regular visits Behavioral motivation: Optimization of medical care in diabetes	Telemedicine Group n=18 Participants After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC. A videotelephone, TandBerg E20, Behavioral motivation: Optimization of medical care in diabetes
Lipids	3.9 milli mols/l Interval 2.7 to 4.9	3.6 milli mols/l Interval 2.4 to 4.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Six months of treatment

Population: diastolic blood pressure

Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207

Outcome measures

Measure	Standard Care n=22 Participants Diabetic patients attended usual procedure in the outpatient clinic with regular visits Behavioral motivation: Optimization of medical care in diabetes	Telemedicine Group n=18 Participants After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC. A videotelephone, TandBerg E20, Behavioral motivation: Optimization of medical care in diabetes
Blood Pressure	73 mmHg Interval 50.0 to 92.0	80 mmHg Interval 58.0 to 95.0

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telemedicine Group

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

Finn Lauszus

Herning Hospital

Phone: +45 78434614

Email: finlau@rm.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place