After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.

After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.

Hypoglycemia Unawareness

Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period

Carvedilol 3.125 mg

Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period

Carvedilol 2.5 mg

Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period

Placebo capsule

University of Utah

Carvedilol in Treating Hypoglycemia Unawareness

The Use of Low-Dose Carvedilol to Improve Hypoglycemia Awareness in Patients With Type 1 Diabetes Mellitus

Participants will complete the Edinburgh Hypoglycemia Symptom questionnaire at baseline and after the 4-week treatment period. The average change in hypoglycemia symptom score will be compared between the carvedilol and placebo groups.

Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood glucagon level will be compared between the carvedilol and placebo groups.

Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood epinephrine level will be compared between the carvedilol and placebo groups.

Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood norepinephrine level will be compared between the carvedilol and placebo groups.

Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood cortisol level will be compared between the carvedilol and placebo groups.

Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood growth hormone level will be compared between the carvedilol and placebo groups.

The number of hypoglycemic episodes as determined by CGM will be determined during the 4-week treatment period and compared to the 1-week pre-study baseline period.

Owen Chan, PhD

Associate Professor of Medicine

Double-blinded, randomized, placebo-controlled study in patients with Type 1 diabetes mellitus and hypoglycemia unawareness

The GDEP consists of two components, which are 1) gamification app on diabetes education, and 2) usual care group (face-to-face discussion with a DNE).
1) Gamification: The development of this gamification app, a mobile-based app of serious gaming, addresses the limitation and few recommendations from the current literature review. It aimed to enhance the user experience, and to facilitate diabetes education in an effective and efficient way, aligning with ADA (2014) guidelines, work instructions, and protocols in one tertiary organization. The learning modules are framed by socio-cognitive framework and self-efficacy. The gaming concept has been implemented into a mobile app, which can be accessed via iOS and Android platforms. It takes an average of 15 minutes to complete per stage. Hence, allowing flexibility for participants to access the games anywhere and anytime using i-pad or mobile devices.

The control group comprises of the standard care or usual care group, which is the face-to-face session with the DNE. The content during each session is dependent upon the individual's needs and concerns, including the reason for referral to DNE by the endocrinologist. For example, teaching the individual patient on self-management of blood glucose (SMBG) and emphasizing on diet modification and exercise if necessary. Educational pamphlets on diabetes management will be given to him/her if deemed necessary. Each session will usually requires an average of 45 minutes, which is considered as long consultation that costs 16 dollars. On the other hand, short consultation is categorised as less than 30 minutes that costs around eight dollars. The difference is that there is no GDEP in the control group. However, after the completion of data collection at six months time, the control group will also receive the intervention (GDEP). This is in order to give them equal opportunity.

Diabetic Patients, Gamification, Diabetic Education

"Diabetic application" focuses on diabetes management and consists of two gamelets and consist of story-telling, case scenarios with the integration of problem-based decision-making and solving skills in diabetes management. These scenarios created are familiar to the patients and nurses - to make the games more interactive and realistic to the players (participants). Immediate feedback will be given after they select their decision. The visual reward will appear after attaining one score for each correct question. Participants can easily access and play the games several times till contents are reinforced and knowledge is retained or at their own comfort level. This game mechanics aim to motivate and assist patients to achieve their desired result and self-efficacy behaviors. It addresses the deficits from the current literature review, by aiming to be up-to-date, reliable with new updated scenarios and platform.

Gamification Diabetes Education Program (GDEP)

11 Jalan, Tan Tock Seng Hospital,

The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients

The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients: A Randomised Controlled Trial.

Clinical indicator to monitor glycemic control for the past three months

Using Self-efficacy tool (Duprez et al., 2013)

KHO SIOK EE SHARON

Principal Investigator, Clinical Instructor

National Healthcare Group, Singapore

Tan Tock Seng Hospital

The study adopted a randomized controlled trial (RCT) design, comparing between intervention group (receiving GDEP) and control group (current practice). In this study, the RCT study design allows comparison between the intervention (GDEP), which will then prove the hypotheses and serves to address the aim of this study.

Assessor blinding is not possible as the researcher is involved in the whole process from recruitment to data analysis as part of her doctorate study. However, a research assistant (RA) will assist in arranging the sequence of the envelopes as part of allocation concealment, double-checking of the data entry and analysis of the report. To highlight, the RA will also not know which is the 'control' and 'intervention' group, as both groups will be de-identified as group A and B during the process of data entry and analysis.

Diabetic patients attended usual procedure in the outpatient clinic with regular visits

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.

Diabetic patients attended usual procedure in the outpatient clinic with regular visits
Behavioral motivation: Optimization of medical care in diabetes

Standard Care

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

Telemedicine Group

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

duration of type 2 diabetes

insulin treatment

Percent of glycosylated hemoglobin, HbA1c

Glycemia

Lipids

Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207

diabetes complications/fatigue

Carvedilol in Treating Hypoglycemia Unawareness

The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients

Telemedicine Strategy With Home Treatment Save Resources

Spanish Diabetes Self-Management Program

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