Trial Outcomes & Findings for Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes (NCT NCT01778751)

NCT ID: NCT01778751

Last Updated: 2016-01-25

Results Overview

Hemoglobin A1c as measured at baseline, 3m, 6m

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

50 participants

Primary outcome timeframe

Baseline, 3months, 6months

Results posted on

2016-01-25

Participant Flow

Recruitment occurred December 2013-May 2014 at the Durham VA Medical Center outpatient primary care clinics.

Participant milestones

Participant milestones
Measure	Control Veterans will receive diabetes educational materials and management per their primary provider	Intervention Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Veterans will receive diabetes educational materials and management per their primary provider	Intervention Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Transfered care	1	0

Baseline Characteristics

Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=25 Participants Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 Participants Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.	Total n=50 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 9.2 • n=5 Participants	60.2 years STANDARD_DEVIATION 8.4 • n=7 Participants	59.9 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3months, 6months

Hemoglobin A1c as measured at baseline, 3m, 6m

Outcome measures

Outcome measures
Measure	Control n=25 Participants Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 Participants Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Diabetes Control Baseline	10.7 percentage of glycosylated hemoglobin Standard Deviation 1.6	10.2 percentage of glycosylated hemoglobin Standard Deviation 1.4
Diabetes Control 3 Months	10.3 percentage of glycosylated hemoglobin Standard Deviation 1.8	9.1 percentage of glycosylated hemoglobin Standard Deviation 1.3
Diabetes Control 6 months	10.4 percentage of glycosylated hemoglobin Standard Deviation 1.6	9.1 percentage of glycosylated hemoglobin Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline, 3m, 6m

Self-Care Inventory-revised as measured at baseline, 3 months, 6 months

Outcome measures

Outcome measures
Measure	Control n=25 Participants Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 Participants Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Diabetes Self Care Baseline	49.8 units on a scale Standard Deviation 9.6	52.3 units on a scale Standard Deviation 14.8
Diabetes Self Care 3 months	53.7 units on a scale Standard Deviation 10.9	58.2 units on a scale Standard Deviation 14.6
Diabetes Self Care 6 months	52.6 units on a scale Standard Deviation 12.6	61.1 units on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline, 3m, 6m

Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months

Outcome measures

Outcome measures
Measure	Control n=25 Participants Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 Participants Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Self-reported Medication Adherence Baseline	17 participants	15 participants
Self-reported Medication Adherence 3 months	11 participants	9 participants
Self-reported Medication Adherence 6 months	9 participants	8 participants

SECONDARY outcome

Timeframe: Baseline, 3m, 6m

Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months

Outcome measures

Outcome measures
Measure	Control n=25 Participants Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 Participants Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Depressive Symptoms Baseline	7.3 units on a scale Standard Deviation 5.5	6.9 units on a scale Standard Deviation 5.6
Depressive Symptoms 3 months	6.6 units on a scale Standard Deviation 5.1	5.5 units on a scale Standard Deviation 6.3
Depressive Symptoms 6 months	5.9 units on a scale Standard Deviation 4.7	6.7 units on a scale Standard Deviation 6.2

Adverse Events

Control

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Intervention

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control n=25 participants at risk Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 participants at risk Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Cardiac disorders Hospitalization	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Respiratory, thoracic and mediastinal disorders Hospitalization	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
General disorders Hospitalization	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Renal and urinary disorders Hospitalization	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Respiratory, thoracic and mediastinal disorders Outpatient Diagnosis	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Psychiatric disorders Hospitalization	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Psychiatric disorders Psychiatric Disorder	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Investigations Hypoglycemia Requiring Asssistance	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.

Other adverse events

Additional Information

Dr Matthew J Crowley

Durham Veterans Affairs Medical Center

Phone: 919-286-6936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control n=25 participants at risk Veterans will receive diabetes educational materials and management per their primary provider	Intervention n=25 participants at risk Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Endocrine disorders Biopsy	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Skin and subcutaneous tissue disorders Biopsy	4.0% 1/25 • Number of events 2 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Ear and labyrinth disorders Ear infection	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Endocrine disorders Hyperglycemia	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Eye disorders Eye pain	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
General disorders Emergency Room Visit	24.0% 6/25 • Number of events 12 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	28.0% 7/25 • Number of events 9 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Infections and infestations Emergency Room Visit	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	12.0% 3/25 • Number of events 3 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Musculoskeletal and connective tissue disorders Emergency Room Visit	12.0% 3/25 • Number of events 3 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Psychiatric disorders Psychiatric Disorder	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Renal and urinary disorders Emergency Room Visit	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	8.0% 2/25 • Number of events 2 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Respiratory, thoracic and mediastinal disorders Emergency Room Visit	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Skin and subcutaneous tissue disorders cellulitis	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Vascular disorders Emergency Room Visit	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Surgical and medical procedures Planned Surgery and Proceedures	4.0% 1/25 • Number of events 1 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	8.0% 2/25 • Number of events 3 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Investigations # Pts with >5 BG Values <70 mg/dL from 1st encounter to end of study	0.00% 0/25 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.	12.0% 3/25 • Number of events 3 • Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts. Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3\&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.